APPENDIX A

THE EFFECTS OF COMPLETION OF A CYCLING PROGRAM ON STRESS URINARY

INCONTINENCE IN POSTMENOPAUSAL WOMEN

Lauren Wu, SPT

A journal article submitted in partial fulfillment of the requirements for the degree of
Doctor of Physical Therapy

Central Michigan University

Mount Pleasant, MI
August 2016

i
 ABBREVIATIONS

Intra-abdominal pressure .......................................................................................................IAP

Pelvic floor muscle(s) ............................................................................................................PFM
Physical activity .....................................................................................................................PA
Quality of life .........................................................................................................................QOL
Stress urinary incontinence ....................................................................................................SUI
Urinary incontinence ..............................................................................................................UI

ii
 DEFINITION OF TERMS

Co-morbidity. A concomitant by unrelated pathologic or disease process; usually used in

epidemiology to indicate the coexistence of two or more disease processes.

http://medical-dictionary.thefreedictionary.com/Co-morbidity

Cycling. The act, sport, or technique of riding or racing on a (stationary) bicycle.

http://www.thefreedictionary.com/cycling

Intra-abdominal pressure. Pressure within the abdominal cavity, such as that caused by
descent of the diaphragm.

http://medical-dictionary.thefreedictionary.com/intra-abdominal+pressure

Muscle re-education. The use of physical therapeutic exercise to restore muscle tone and
strength after an injury or disease.

http://medical-dictionary.thefreedictionary.com/muscle+reeducation

Pelvic floor muscles. The muscles that span the pelvic floor and support pelvic organs,
consisting of fibers of the coccygeus and the levator ani muscles, the latter which is composed of
three fascicles: 1) Pubococcygeus-the main part of the levator, which runs form the body of the
pubis to the coccyx, with some fibers reaching the prostate, urethra, and vagina 2) Puborectalis
has right and left fascicles which unite behind the anorectal junction, forming a muscle sling that
is part of the external anal sphincter; 3) Iliococcygeus is the posteriormost part of the pelvic foor
and is poorly developed.

http://medical-dictionary.thefreedictionary.com/pelvic+floor+muscles

Postmenopausal women. Women aged 55 years or older and who had no natural
menstrual cycle in the preceding 12 months.

Jackson SL, Scholes D, Bokyo EJ, Abraham L, Fihn SD. Predictors of Urinary
Incontinence in a prospective cohort of postmenopausal women. Obstet Gynecol.
2006;108:855-862.

iii
 Prevalence. The percentage of a population affected with a particular disease at a given
time.

http://www.merriam-webster.com/dictionary/prevalence

Stress urinary incontinence. A sudden, involuntary release of urine caused by muscular

strain accompanying laughing, sneezing, coughing, or exercise, seen primarily in older women
with weakened pelvic musculature.

http://www.thefreedictionary.com/stress+incontinence

Socioemotional well-being. A general and relatively stable emotional state that indicates
the emotional evaluation, positive or negative, that an individual makes of the result of the
totality of his/her social interactions.

Bericat. The socioemotional well-being index (SEWBI): theoretical framework and

empirical operationalization. Social Indicators Research. 2014;119(2):599-626.

iv
Chapter 1:
Statement of the problem ...........................................................................................1
Stress urinary incontinence ............................................................................1
Diagnostic tests ..............................................................................................1
Impact ............................................................................................................2
Postmenopausal women .................................................................................2
Types of interventions....................................................................................3
Physical activity .............................................................................................3
Walking ..........................................................................................................3
Cycling ...........................................................................................................4
Purpose Statement ......................................................................................................4
Assumptions...............................................................................................................4
Hypothesis..................................................................................................................5
Delimitations ..............................................................................................................5
Limitations .................................................................................................................6
Chapter 2:
Review of related literature ........................................................................................8
Prevalence of SUI ..........................................................................................8
Risk factors ....................................................................................................8
Problem in postmenopausal women ..............................................................9
Socioemotional and physical impact .............................................................9
Financial impact .............................................................................................10
Surgical interventions ....................................................................................10
Pharmacotherapy interventions ......................................................................11
Conservative interventions.............................................................................12
Pelvic floor muscle function and interventions .............................................12
Physical activity as treatment.........................................................................13
Cycling as an alternative intervention............................................................13
Chapter 3:
Procedures ..................................................................................................................15
Research design .............................................................................................15
Sample population .........................................................................................15
Internal and external validity .........................................................................16
Instrumentation ..............................................................................................17
Data analysis ..................................................................................................18
Operational procedures ..................................................................................19
References ..............................................................................................................................23

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 CHAPTER 1
STATEMENT OF THE PROBLEM

Stress urinary incontinence. The purpose of this study was to investigate the effects of a

cycling program on Stress Urinary Incontinence (SUI) in postmenopausal women. SUI is a type

of urinary incontinence in which involuntary leakage of urine occurs during physical activity or

exertion. SUI occurs during events in which intra-abdominal pressure (IAP) increases and is

greater than urethral pressure. This puts stress on the pelvic floor muscles (PFM), often resulting

in leakage of urine7. These are events in which IAP becomes greater than intra-urethral pressure,

such as laughing, coughing, sneezing, exercising, and lifting. This differs from urge

incontinence, defined as involuntary bladder contractions or bladder dysfunction causing sudden,

extreme urges to urinate. In a recent study, Saha et al. 2013 found that 44% of women ages 51-

55 reported having urinary incontinence in general, with 61% of those cases SUI specifically.

Another study by Jackson, et al. 2006 estimated SUI occurring in 66% of their subjects.

Diagnostic tests. Several tests are available to aid in the diagnosis of SUI. These include

pelvic and/or rectal exams, cystoscopies, examining voiding diaries, diagnostic ultrasound,

urinalysis, urodynamic studies, and 1-hour pad tests30. Pelvic or rectal exams can be performed

to determine PFM weakness. Cystoscopies are performed to examine the inside of the bladder

and associated structures. Voiding diaries kept by women typically contain information of how

much fluid was consumed, at what times they were consumed, activities performed when

episodes of leakage occurred, how many times the woman had to use the bathroom or change

sanitary pads, and other details. Diagnostic ultrasound can be used to examine intra-pelvic

structures via an extra-pelvic approach, and may be used to detect any hypermobility of

structures. Urinalyses are done to rule out any other pathologies that may be causing SUI.

Urodynamic testing can be performed to evaluate urethra and and bladder functioning.

1
 Impact. For many women, these symptoms can pose issues in their socioemotional,

physical and sanitary wellbeing. This condition can have detrimental effects on quality of life

(QOL), given that leakage occurs during normal, everyday functions. The degree of severity can

vary from a few drops to wetting undergarments. Women may take extra precautions to alleviate

the impact SUI has on their daily routines. These behavior changes include decreasing fluid

intake, avoiding caffeinated, alcoholic, or highly acidic beverages, avoiding strenuous activity,

and wearing sanitary pads30. Additionally, socioemotional wellbeing is negatively impacted, as

SUI can lead to feelings of fear, shame, humiliation, helplessness, depression, anxiety, or loss of

self-confidence38. Indeed, these feelings may not allow women to feel at ease when discussing

these issues or seeking treatment, which further impacts their QOL. Effective treatment for SUI

is imperative in order to preserve the socioemotional and physical well-being of the large

percentage of women it affects.

Postmenopausal women. Postmenopausal women are particularly of interest due to the

physiological changes they experience after menopause, and other common risk factors they

possess. Estrogen hormone levels are significantly decreased during and after menopause, which

can affect the urinary tract and lead to symptoms of SUI. Kobata, et al. 2008 proposed estrogen

hormone therapy may combat the negative effects of SUI. Other risk factors for developing SUI

include aging, pregnancy or child birth, obesity, smoking, pelvic floor muscle laxity, poor pelvic

floor muscle contractility, injury to the pelvic structures, history of urinary tract infections,

history of pelvic cavity surgeries such as hysterectomy, denervation, and devascularization14,26.

Certain comorbidities, such as obesity or diabetes, may worsen symptoms of SUI. It is a result of

all of these changes and potential comorbidities that SUI is a common issue in this population

and should be studied further.

2
 Types of interventions. Given the complexity individual cases of SUI in this population

may present with, a variety of treatment options should be explored for this population. There are

three main types of interventions for SUI: pharmacotherapy, surgery, and conservative

treatments. One common intervention as mentioned is estrogen hormone replacement therapy.

While this seems like a logical approach, Hendrix, et al. 2005 found that estrogen therapy had no

effects in alleviating symptoms of SUI. Surgical intervention includes vaginal repair in cases of

prolapse, bulking injections, and vaginal tapes or slings30. Conservative behavioral approaches

include dietary changes, losing weight, and quitting smoking. One of the leading treatments for

SUI is PFM exercise. Physical therapists who specialize in pelvic floor rehabilitation can help

women identify PFM, and facilitate muscular re-education and strengthening through use of

interventions such as PFM exercises and biofeedback devices41.

Physical activity. Physical activity contributes to the wellbeing of pelvic and abdominal

structures. General benefits, depending on the mode, include increases in aerobic endurance,

skeletal muscle strength, improved sleep, improvements in blood profiles, and reduced blood

pressure29. Some women may tend to avoid exercise, however. Strenuous activity such as

resistance training, plyometric exercises, and running tend to worsen SUI symptoms due to IAP

increases42. Lower intensity physical activity can help to reduce body weight and reduce fat

mass, which may help decrease IAP, thereby decreasing stress on PFM29.

Walking. Women who walked regularly were found to be associated with decreased risk

of developing urinary incontinence6. It may be prescribed as part of an exercise program for

women with SUI because the IAP during walking fluctuates between a relatively low range as

compared to other higher intensity activities42. Furthermore, it is inexpensive, low-intensity, easy

to get involved, and can be done just about anywhere. Additionally, lower extremity muscles

3
with attachments to the pelvis have fascial connections to the PFM. During walking, these lower

extremity muscle contractions may facilitate neuromuscular activation in PFM, which may

enhance their functioning.

Cycling. One alternative to walking is cycling. Similar to walking, cycling helps increase

skeletal muscle strength, aerobic endurance, and cardiovascular health24. Indeed, one advantage

may be that IAP during this activity is lower than in walking, which puts less stress on PFM42.

While cycling is not as flexible, accessible, easy to learn, or inexpensive as walking, the benefits

may outweigh the costs. Stationary cycling can reduce the learning curve necessary for riding,

and is often indicated for individuals who cannot tolerate the impact of weight-bearing on their

joints. Cycling in groups may have a positive effect on social and emotional wellbeing and may

increase motivation and adherence to an exercise program. As such, cycling may be preferred by

some women. It may have implications as an alternative or supplement to alleviating symptoms

of SUI and should be explored as a potential treatment intervention.

PURPOSE STATEMENT

The purpose of this study was to investigate the effects of a cycling program on Stress

Urinary Incontinence (SUI) in postmenopausal women. The study focused on postmenopausal

women in Southeast Michigan who reported mild to severe symptoms of SUI. The results

contributed to current interventions of reducing or eliminating symptoms of SUI.

ASSUMPTIONS

There were several assumptions determined for this study. The researcher assumed that

all published research articles and internet sources used in this paper were factual, complete, and

current at the time of their publication. Additionally, it is assumed that the participants in the

4
study were honest and accurate in their reports of symptoms during the intervention. During the

intervention portion of the study, it was assumed that participants were motivated to be able to

maintain the intensity required in order to receive benefits of the exercise modality. It is also

assumed that after instruction by the research investigator, participants were able to successfully

perform the intra-pelvic strength tests and that the participants performed with maximal effort. In

regard to the research investigator, it was assumed that after proper instruction, the investigator

was able to properly administer all participant directions and use of instruments (e.g.,

questionnaires, cycling equipment, biofeedback devices) in a standardized manner.

HYPOTHESIS

SUI remains a common issue in postmenopausal women. The research will show whether

completion of a cycling program will positively impact symptoms of SUI in postmenopausal

women vs a control group who does not complete a cycling program, using an experimental pre-

test/post-test design.

DELIMITATIONS

One delimitation of this study was that it focused on women defined as postmenopausal,

or were over 55 years of age who have not experienced a menstrual cycle for one year or more.

Postmenopausal women may respond to this treatment different than those who are

premenopausal or currently undergoing menopause.

The study was also delimited to postmenopausal women were diagnosed with SUI and

whose symptoms were rated as mild to severe symptoms. Symptoms were described by

individual subjects according to how many times they leaked urine in the previous seven days

and it was assumed that accurate categorization was given by the research investigator.

5
 This study was delimited to participants living in the southeast Michigan area. This area

was selected because there were greater resources available to the researcher in terms of greater

number of clinics and hospitals in which to recruit a large sample size.

Typically, stronger PFM correlate with decreased symptoms of SUI. Therefore, the study

chose to examine PFM strength as an indicator of change in symptoms of SUI at the start,

during, and at completion of the intervention. This will include an intra-pelvic strength measure

using an intravaginal probe device to objectively determine the pressure exerted by PFM on the

vagina, which will represent PFM strength. Additionally, the data will be triangulated via a

survey to investigate any changes in SUI symptoms, specifically regarding incidents of leakage

and sanitary pad use. This will be done in order to facilitate validation of the data collected.

LIMITATIONS

Until the study is conducted, actual limitations cannot be ascertained. Potential

limitations include that the study may be limited to volunteers who had access to health care, as

they were recruited from clinics and hospitals in southeast Michigan. The research may be

unable to limit any cultural differences among those who were surveyed and participated.

Another potential limitation is subject attrition. The study will involve sustained,

moderate intensity cycling. Some subjects may find difficulty with maintaining this level of

physical activity and may be inclined to cease their participation. This would affect the study by

decreasing the sample size of the population and decreasing the generalizability of the results.

Another limitation may be maintaining the physical rigor of the cycling intervention. The

research investigator will attend the session and record heart rate as a measure of intensity for

each cyclist. However, this will only be done every five minutes in order to be able to record

each cyclists heart rate, meaning the researcher will not be able to monitor each participant all

6
the time. Therefore, it cannot be guaranteed that each participant is cycling within the desired

heart rate range in order to maintain the cycling intensity adequate for the benefits of exercise to

be obtained.

7
 CHAPTER 2
REVIEW OF RELATED LITERATURE

The purpose of this study was to investigate the effects of completion of a cycling

program on stress urinary incontinence (SUI) in postmenopausal women. The study is an

experimental design focusing on pre-test and post-test measures of pelvic floor muscle (PFM)

strength, number of incontinent episodes, and number of sanitary pad changes. The results

contributed to current interventions of reducing or eliminating symptoms of SUI.

Prevalence of SUI. Rates for prevalence of SUI slightly vary across different groups,

such as between men and women, or older and younger individuals. Some studies suggest over

200 million, and possibly up to 250 million women worldwide experience urinary incontinence

(UI)19,46. SUI typically is the most common type UI. Nguyen, et al. 2011 maintain a rate of

49.8% of women with SUI in the United States. Jackson, et al. 2006 reported the incidence of

SUI at 66% of its subjects, postmenopausal women ages 51-55 years old. Some studies show

differences in SUI rates according to racial groups. Nygaard and Heit 2004, supports the finding

that blacks and Hispanics in contrast to non-Hispanic whites were less likely to experience

severe incontinence symptoms by up to 60%. Townsend, et al. 2014 found rates of SUI rather

than urge incontinence were most common in its white participants, followed by its Asian and

black participants.

Risk Factors. There are numerous risk factors that may contribute to developing SUI.

Currently identified risk factors include female sex, age, body mass index (BMI), waist-to-hip

ratio, pregnancy or childbirth, menopause, chronic strain or cough, weak or injured pelvic floor

muscles (PFM), short urethra, nerve injury or devascularization in PFM, race or genetics, and

history of hysterectomy2,3,9,14,16,19,36. Additionally, women with diabetes were associated with

8
developing UI with an increase in risk by as much as 70%2,14. Obesity is also a risk factor.

Kamel, et al. 2013 found that for each five kg/m2 increase in body weight in obese individuals,

there was an associated 60-100% risk of developing UI.

Problem in postmenopausal women. UI in general is particularly prevalent in

postmenopausal women. Given the multitude of physiological changes postmenopausal women

experience and the various risk factors they possess, this population may need special attention

when it comes to treating SUI. Jackson, et al. 2006 found that 66% of postmenopausal women in

their study reported UI. Indeed, postmenopausal women often possess many of the risk factors

for developing UI, including being older age, being of female sex, and often have a history of

being pregnant, childbirth, or pelvic surgeries. Menopause results in decreased estrogen levels,

which in combination with aging can result in many systemic bodily changes. These include

body composition changes in terms of weight gain, fat redistribution, muscle mass and strength

changes29.

Socioemotional and physical impact. The extent to which an individuals

socioemotional and physical wellbeing are affected by SUI is typically dependent on the severity

of SUI symptoms. Dealing with the symptoms of SUI can negatively impact several major,

normal life functions such as work productivity, household chores, participation in recreational

activities, traveling, sports, and engaging in sexual activity38. Individuals may experience

feelings of decreased QOL, social isolation, psychologic distress, fear, shame, humiliation,

helplessness, depression, anxiety, and loss of self-confidence11,34,38. The nature of SUI is

inherently associated with physical health and hygiene risks18. While sanitary napkins are an

option, not all women may use them, which poses a hygiene risk if they are not able to change

9
their undergarments. Additionally, the condition may increase risk for falls in older individuals

who need to void at night11.

Financial impact. The financial aspect of dealing and treating SUI can be costly, with

health care cost estimates as much as between $19.5-32 billion in the United States18. Fultz, et al.

2003 estimated a total cost of $3565 per person with incontinence in 1995. Typical expenses can

include use of sanitary pads, which was estimated to make up 63% of out of pocket costs, with

other costs being additional loads of laundry and dry cleaning44. Health care costs may be

expected to increase as the population ages and as more women seek treatment35.

Surgical interventions. Surgery has historically been the major approach for treating

SUI. While many surgeries have had high success and satisfaction rates, the high cost, intra- and

post-operative complications and fears and anxiety regarding surgery are still present, which

warrants the need for development and research of alternative approaches. Minimally invasive

procedures include mid-urethral slings, pubovaginal slings, transobturator tapes and tension-free

vaginal tapes to provide support to and reduce hypomobility of the urethra1,47. Slings have been

shown to have good long-term cure rates, however risk of infection, inflammation, and vaginal

erosion due to impaired wound healing or friction have been noted47. Surgical complications

include urethral obstruction or bleeding due to punctured endopelvic fascia. Another minimally

invasive procedure is bulking agents, such as fat, Teflon, silicone, collagen, can be injected into

the periurethral or transurethral space underneath the mucosa layer of tissue47. Cure rates are

mildly successful, between 20-40%, and satisfaction rates one year after surgery are between 70-

80%47. Artificial sphincters implanted at the bladder neck can be inflated and deflated

electronically as necessary for the individual. With this method, there were improved SUI

symptoms, as shown with decreased pad use to one pad or zero pads in 52% and 27.1% of its

10
subjects respectively18. However, there are several factors that outweigh the potential benefits.

These include high costs, surgical complications such as implantation difficulties and infection,

high mechanical failure rate, low success rate with repeat surgeries to replace or remove devices,

tissue erosion, and potential for dyspareunia. Paravaginal defect repairs restore the anatomical

relationships of structures in the pelvic cavity. Although the cure rate was 79% in one studys

subjects, this surgery is invasive and there were some complaints of return of incontinence

symptoms, voiding dysfunction, and vaginal prolapse4.

Pharmacotherapy interventions. Pharmacotherapy and hormone therapy have had

mixed to positive success. Treatment of SUI using drugs is often more cost-effective, fast-acting,

is not time consuming, and may have result in better adherence in comparison to conservative

therapies. Despite this, adverse side effects may deter individuals from using these drugs. Some

studies support the use of duloxetine, which functions mainly to increase bladder capacity.

Positive outcomes were reduction of episodes of incontinence and improved ratings of QOL,

although several side effects such as nausea, fatigue, insomnia, dry mouth, constipation,

dizziness, and headaches were noted28,32,51. Another drug, raloxifene, was tested for use in

postmenopausal women but there no reduction in SUI symptoms were found12. The main

pharmacotherapy approach is estrogen, which has been used to treat SUI specifically in

postmenopausal women, who experience decreased estrogen levels as a result of menopause.

Estrogen receptors exist on structures that have roles in maintaining intra-urethral pressure, thus

maintaining continence. Loss of estrogen diminishes periurethral vessels, decreases mucosa-

submucosal layer size of PFM, and may inhibit relaxation in the detrusor muscle of the

bladder20,23. The evidence supporting estrogen therapy to treat SUI specifically in

postmenopausal women is controversial. Indeed, a few studies show or maintain the notion that

11
estrogen therapy was associated with worsened symptoms of UI13,14. These findings may be

attributed to the use of orally-administered estrogens rather than local estrogens such as topical

creams or capsules. That said, there are several studies that show or maintain the benefit of

locally-applied estrogens to improve UI symptoms21,23,25,31,41,47.

Conservative interventions. Conservative approaches to managing SUI symptoms have

gained more popularity, as they are often safer and are often less costly. Many women take

precautions to avoid the consequences of SUI, which include behavioral and lifestyle changes.

These include using sanitary napkins throughout the day, limiting fluid intake, avoiding ingestion

of citrus and spicy foods, or consumption of beverages containing alcohol, caffeine or coffee,

and carbonation, losing weight, smoking cessation, and avoiding strenuous activity28,30,49. More

involved conservative methods include bladder training, physical therapy, PFM exercises.

Bladder training involves scheduling, relaxation, and distraction techniques to improve cortical

inhibition over urinary functioning50. Physical therapy can aid in correctly identifying PFM,

learning how to contract PFM in a coordinated fashion, and strengthening to facilitate behavioral

modifications5,16. Other techniques employ biofeedback devices, vaginal cones, and electrical

stimulation to improve strength and coordinated contractions16.

Pelvic floor muscle function and interventions. PFM exercises are currently considered

the first line of treatment, considering their importance in urogenital health and function. PFM

play important roles in abdominal viscera support, responding to intra-abdominal pressure (IAP)

increases, bladder voiding, defecation, and sexual arousal and activity26. The proposed

mechanisms of dysfunction are that PFM lose strength due to muscle laxity, injury, connective

tissue degradation, pelvic denervation or loss of vascularization, which are thought to occur with

normal aging10. Other structures contribute to the functioning of the pelvic floor as well. The

12
vagina can facilitate muscle movements in the neck of the bladder and supports stretch receptors

located there and in the urethra43. Further, sacral rotational movement can affect the size of

retropubic space, in which the distance between the coccyx and symphysis pubis and the width

of the pelvis may elongate and weaken fascial and ligamentous structures. When the PFM

structures are compromised, they cannot provide structural support or withstand increased IAP,

leading to dysfunction of the urethral sphincter and involuntary leakage. While various

strengthening protocols exist and have been shown to be successful, the nature of this approach

can be time consuming, requires high self-motivation, requires proper instruction to correctly

perform exercises, requires several weeks to months before benefits manifest, and may result in

low compliance34. Nonetheless, strengthening of PFM can facilitate urethral closure during IAP

increases, thus preventing leakage15,16,35,41,49.

Physical activity (PA) as treatment. Engaging in lower intensity PA may aid in

improving SUI symptoms. This may be particularly beneficial in overweight or obese women.

PA can facilitate weight loss, decrease adipose tissue mass, and decrease IAP6,17,36,48. IAP

increases during repetitive, less-severe impact exercise could cause co-contraction of abdominal

muscles and PFM. This could actually help improve PFM function17,27. Walking is popular mode

of safe, low-intensity exercise, given that it is relatively inexpensive, accessible, and safe to

perform. Indeed, Danforth, et al. 2007 found that its subjects who walked regularly were

associated with decreased risk of developing UI.

Cycling alternative as an alternative internvention. Cycling may be an alternative to

walking to help improve SUI symptoms. Cycling has many of the same benefits as walking, such

as increased aerobic endurance, cardiovascular health, and musculoskeletal improvements24.

Traditional cycling can pose some disadvantages, such as higher costs in terms of equipment. It

13
can also be difficult for some individuals, due to balance issues, unfamiliarity with the activity,

or decreased lower extremity range of motion. However, stationary cycling may be beneficial for

older populations. On a stationary bike, the need for balance and the learning curve may be

lessened. Stationary cycling can be completed in group cycle sessions, which can boost

motivation and compliance for exercising in a positive, fun environment. Moreover, it may be

appealing to older populations who have degenerative joint disorders since cycling has lower

impact on joints and the spine in contrast to other weight-bearing activities. A study by Shaw, et

al. 2014 found that in its subjects, women 18-54 years old, IAP was on average 8.1 and 10.8

cmH2O in seated cycling at 300 and 600 kgmmin-1 respectively. This was lower than in walking

different speeds at different inclines, with IAP ranging from 24.6 to 35 cmH2O, and lower than

in running which had the highest IAP at 66.5 cmH2O. For postmenopausal women with SUI,

these reasons may make exercise more comfortable and increase adherence rates. Therefore, this

population may benefit from completing a cycling program to help improve symptoms of SUI.

14
 CHAPTER 3
PROCEDURES

RESEARCH DESIGN

The purpose of this study was to investigate the effects of a cycling program on stress

urinary incontinence in postmenopausal women. It was an experimental study using randomized

control and intervention groups with pre-tests and post-tests for each group. The independent

variable was whether or not the subject completed the cycling program intervention. The

dependent variables included pad weight after urinary stress pad test, number of self-reported

incontinent episodes experienced per week, number of sanitary pads used per week, and pelvic

floor muscle strength.

SAMPLE POPULATION

The sample for this study was drawn from a population of postmenopausal women

residing in southeast Michigan who were seeking treatment for SUI. Women were defined as

postmenopausal is if they had not experienced a natural menstrual cycle for one year or more. A

letter was sent to clinics in the southeast Michigan area informing physicians about the study.

This letter encouraged physicians to invite patients they had with SUI to participate in the study.

While the physicians would not be directly impacted or receive any benefits from this invitation

or the study itself, physicians were informed that their role in this recruiting process would

contribute to the current knowledge of SUI treatment and help solidify new alternatives.

Physicians were encouraged to speak with their patients who were postmenopausal women and

presented with mild to severe SUI symptoms. If the patient expressed interest in the study, the

physician forwarded the research investigators contact information. Patients who contacted the

research investigators were given further information regarding the study. If the patient was still

15
interested, their eligibility to participate was determined via a phone screening. Eligible

volunteers received a consent form for their review in the mail and instructions about the

location and expectations for the study. Forty women were drawn from this population, and were

randomly assigned to either the control group or the intervention group.

INTERNAL & EXTERNAL VALIDITY

There were some threats to internal validity present in this study. The testing effect may

have contributed to the results of the pelvic floor muscle strength test. Subjects were taught to

correctly identify and properly contract the pelvic floor muscles. The pre-test and post-test were

performed at the beginning and end of the 12 weeks. From the initial to the final time points,

subjects may have learned to be able to produce stronger and more coordinated muscle

contractions as a result of learning how to target and activate the correct PFM and perform the

test using the biofeedback device.

Another potential threat was experimental mortality. Subject attrition was minimized by

stressing to participants the importance of attending all group cycling sessions and completing

the entire cycling program. Attempts were made to make the group cycling sessions a

comfortable and positive experience to encourage participation. Subjects were also reminded that

their involvement in the study would contribute to findings regarding new treatments for SUI.

Instrumentation posed a threat to internal validity. A skilled physical therapist

administered the biofeedback device to measure PFM strength, ensuring that the device was

inserted and maintained in the correct location to obtain accurate measures. Additionally, it was

assumed that subjects were honest and complete in their self-reported surveys for reports on their

sanitary pad use and number of incontinent episodes.

16
 Compensatory rivalry was also a potential threat. Attempts were made to ensure that

subjects in the control group had no contact with the intervention group to minimize the effects

of social competition. The control group did not attend the group cycling sessions. The

intervention group cycling sessions took place in a fitness center off campus from the location of

testing measures. The variables measured were taken for each individual subject in private

sessions with a research investigator.

A potential threat to external validity was the interaction effect of testing. In order to

minimize subject drop-out rates in the intervention group, attempts were made to ensure cycling

sessions were comfortable and fun, although this could have had a higher motivational effect in

some participants more than others. Research investigators and the physical therapist received

instruction to standardize their interactions, testing, and questions as much as possible. However,

this cannot account for all tester characteristics that may have been present during the study.

Finally, the effect of multiple-treatment interference was minimized. Participants were

instructed to refrain from partaking in other treatment interventions, such as other experimental

studies, physical therapy, PFM strengthening, or using new medications to treat symptoms.

INSTRUMENTATION

One variable measured was PFM strength. The device used was a vaginal probe

transducer (BEAC Biomedical, Italy), the same as used by Sanches, et al. 2009. It was connected

to a Motorola MPX2010DP solid-state pressure sensor. This probe measured the intravaginal

pressure generated by the participant in mmHG, which would translate to a measure of PFM

strength. This tool, rather than a regular biofeedback device, accounts for changes in ambient

temperature (i.e., from room temperature to intravaginal temperature) that may affect the

17
pressure reading. More information about the reliability and validity needs to be established for

this tool, as it appears to be relatively new.

Another variable measured was the 1-hour pad test, an inexpensive and easy task to

administer. At the initial and final time points, subjects would complete this test, in which a 1

gram gain in pad weight was considered positive for incontinence. The protocol used was the

same used by Liebergall-Wischnitzer, et al. 2010. This was established as an acceptable test for

measuring severity of SUI symptoms. The same study found a reliability correlation coefficient

of .422 between pad test results and QOL questionnaires, which was statistically significant

within its subjects. This coefficient is as high as .88 in other studies8. Good validity was also

established8.

Finally, a survey was given to each subject to complete at the initial and final time points.

These were self-reported, written surveys with 14 questions regarding symptoms of SUI. This

was the same questionnaire used by Fultz, et al. 2003, who found reproducibility of the

questionnaire in a smaller set of participants to be .80. Primary questions included how many

incontinent episodes the participant had experienced that week. It also asked how many sanitary

pads the participant had to use that week.

DATA ANALYSIS

PFM strength is the force the PFM can maximally contract. It is typically a good

technique to use to represent how well an individual can maintain continence because of the

muscles role in closure of the urethra. PFM strength was measured at initial and final time

points in both the intervention and control groups. The dependent variable was using intravaginal

pressure in mmHG as a measure of PFM strength, which generated ratio data. These data was

analyzed using a 2x2 ANOVA test with a critical value set at .05.

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 The 1-hour pad test measures the weight of the pad with liquid weight after the 1-hour

pad test. This is a good technique to use to determine the extent of involuntary leakage. Weight

was measured at the initial and final time points in both the intervention and control groups. The

dependent variable was pad weight measured in grams, which generated ratio data. These data

was also analyzed using a 2x2 ANOVA test with a critical value set at .05.

Finally, the number of incontinent episodes and number of pads used per week was

measured. These are good indicators of the frequency and severity of involuntary leakage. Like

the previous tests, it was measured at the initial and final time points in both the intervention and

control groups. The dependent variable was number of incontinent episodes and number of pads

used per week, which generated ratio data. A 2x2 ANOVA test was also used to analyze these

data with a critical value set at .05.

OPERATIONAL PROCEDURES

All subjects who contacted the research investigator after being invited to participate by

their physician were interviewed via phone to determine their eligibility for the study. Subjects

were asked about their menopausal status, date of last menstrual cycle, current level of physical

activity, if they were currently seeking treatment for SUI, their symptoms of SUI and their

extent, and their medical and surgical history. After they were determined to be eligible, they

were sent further information and an informed consent form in the mail, as well as information

on location and dates of testing. Measures to ensure patient confidentiality and privacy were

taken. All participants were informed of the potential benefits and risks of their participation in

the study. All participants were also informed that their involvement in the study was completely

voluntary and that they could withdraw at any time.

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 Subjects were randomly assigned to two groups: the control group, which received no

treatment, and the intervention group, which received the 12 week cycling program treatment.

All subjects were instructed to maintain their regular diet, sleep schedule, physical activity, and

all other normal daily activities. All subjects were told to refrain from joining other studies, using

medications to treat their SUI symptoms, partaking in PFM strengthening outside the study, or

make other drastic health changes.

The study was 12 weeks long. All subjects underwent individual test measures on the

first and final days of the study, or the initial and final time points. These measures were taken in

a private space with a trained research investigator administering the 1-hour pad test and the self-

report survey. There was also a skilled physical therapist who administered the PFM strength

measure. Neither the research investigator nor the physical therapist were aware of the subjects

status in the study.

The research investigator administered the 1-hour pad test at the initial and final time

points according to the following protocol: This involved instructing participants to refrain from

voiding two hours prior to the test and to wear a sanitary pad weighed prior to the test.

Participants drank 500 mL of sodium-free water while seated. They then performed the

following tasks: Walking for 30 minutes; Walking up and down 24 steps; standing and sitting 10

times; coughing 10 times; running in place for one minute; picking up a light object off the floor

five times; and placing their hands underwater for one minute. The pad was then reweighed.

They also administered the survey which was given to the subject to self-report answers

in writing. The survey consisted of the follow primary questions regarding their SUI symptoms:

1) How many episodes of incontinence did you experience in the past seven days? 2) How many

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pads did you use in the past seven days? And 3) How would you rate the severity of your

symptoms on a scale of 1-5, 1 being not at all, 5 being severe?

Also at the initial and final time points, PFM strength was measured and recorded. The

initial time point required that the subject learn how to properly identify and contract her PFM

with help from a physical therapist. The subject was positioned in supine on a comfortable

adjustable table with appropriate pillow support and draping for privacy. The physical therapist

digitally palpated the muscles intravaginally using a sterile glove and gel. The subject was then

instructed to contract the muscles by pulling upward as if stopping a stream of urine, rather

than bearing down and straining. After the subject was educated on PFM contraction, the

vaginal probe was self-inserted intravaginally by the subject. The physical therapist ensured the

vaginal probe was positioned correctly throughout the duration of the test measure. The physical

therapist then instructed the subject to maximally contract her PFM for a duration of 3 seconds

while maintaining normal breathing. The probe measured the intravaginal pressure and was

recorded using computer software. Three trials were taken, and the highest of the three trials was

taken as the initial time point PFM strength measure. This process was repeated at the final time

point.

The control group received no treatment during the 12 weeks. The intervention group met

at a location offsite from the facility used to take individual subject test measures. The

intervention group met three times a week for one hour of group stationary cycling with a

cycling instructor present to provide instruction and encouragement to the group. A research

investigator was present to help manage the group, with duties such as adjusting bikes to

individual characteristics and setting up heart rate monitors. Prior to the start of the cycling

program, the maximal heart rate was determined for each subject using 220 minus the subjects

21
age. Their target heart rate was determined by multiplying this number by 75%. Additionally,

each subjects weight was taken and multiplied by 5%. The bikes were individually adjusted

with that weight in resistance. These were done in order for the subject to maintain her heart rate

in a certain range, therefore achieving the desired intensity in order for the positive benefits of

the physical activity to be gained. The instructor guided the group through a 10-minute warm-up

with no resistance, a 40-minute cycling session while maintaining the desired heart rate against

resistance with one-minute break halfway through, and a 10-minute cool-down with no

resistance.

22
 REFERENCES

1. Abougamrah A, Ibrahim M, Elsabaa H, Ellaithy M, Sweed M. Treatment of stress urinary

incontinence with a generic transobturator tape. Int J Gynecol Obstet. 2015;130(3):226-
229.

2. Bani-Issa WA, Halabi JO, Abdullah AR, Hasan HA, Raigangar VL. Prevalance and risk
factors for incontinence among Emirati women with diabetes. J Transcult Nurs.
2014;25(1):42-50.

3. Brown JS, Grady D, Ouslander JG, Herzog AR, Varner RE, Posner SF. Prevalence of
urinary incontinence and associated risk factors in postmenopausal women. Obstet
Gynecol. 1999;94:66-70.

4. Bruce RG, El-Gallery ES, Galloway NT. Paravaginal defect repair in the treatment of
female stress urinary incontinence and cystocele. Adult Urology. 1999;54(4):647-651.

5. Cammu H, Van Nylen M, Blockeel C, Kaufman L, Amy JJ. Who will benefit from pelvic
floor muscle training for stress urinary incontinence? Amer J Obstet Gynecol.
2004;191(4):1152-1157.

6. Danforth KN, Shah AD, Townsend MK, et al. Physical activity and urinary incontinence
among healthy, older women. American College of Obstetricians and Gynecologists.
2007;109(3):721-727.

7. Doumouchtsis SK, Chrysanthopoulou E. Urogenital consequences in ageing women. Best

Practice & Research Clinical Obstetrics & Gynecology. 2013;27(5):699-714.

8. Ferreira CH, Bo K. The pad test for urinary incontinence in women. J Physiol.
2015;61(2):98-98.

9. Fitzgerald MP, Mollenhaeur J, Hale DS, Benson JT, Brubaker L. Urethral collagen
morphologic characteristics among women with genuine stress incontinence. Amer J
Obstet Gynecol. 2000;182(6):1565-1574.

10. Fitzgerald MP, Burgio KL, Borello-France DF, et al. Pelvic-floor strength in women with
incontinence as assessed by the Brink scale. Phys Ther. 2007;87(10):1316-1324.

11. Fultz NH, Burgio K, Diokno A, Kinchen KS, Obenchain R, Bump R. Burden of stress
urinary incontinence for community-dwelling women. Am J Obstet Gynecol.
2003;189:1275-1282.

12. Goldstein SR, Johnson S, Watts NB, Ciaccia AV, Emerick D, Muram D. Incidence of
urinary incontinence in postmenopausal women treated with raloxifene or estrogen.
Menopause: The Journal of the North American Menopause Society. 2005;12(2):160-
164.

23
13. Hendrix SL, Cochrane BB, Nygaard IE, et al. Effects of estrogen with and without
progestin on urinary incontinence. JAMA. 2005;293(8):935-948.

14. Jackson SL, Scholes D, Bokyo EJ, Abraham L, Fihn SD. Predictors of Urinary
Incontinence in a prospective cohort of postmenopausal women. Obstet Gynecol.
2006;108:855-862.

15. Kamel DM, Thabet, AA. Tantawy SA, Radwan MM. Effect of abdominal versus pelvic
floor muscle exercises in obese Egyptian women with mild stress urinary incontinence: a
randomized controlled trial. Hong Kong Physiotherapy Journal. 2013;31(1):12-18.

16. Kashanian M, Ali SS, Nazemi M, Bahasadri S. Evaluation of the effect of pelvic floor
muscle training (PFMT or Kegel exercise) and assisted pelvic floor muscle training
(APFMT) by a resistance device (Kegelmaster device) on urinary incontinence in
women: a randomized trial. Eur J Obstet Gynecol. 2011;159(1):218-223.

17. Kikuchi A, Niu K, Ikeda Y, et al. Association between physical activity and urinary
incontinence in a community-based elderly population aged 70 years and over. Eur Urol.
2007;52(3):868-875.

18. Kim SP, Sarmast Z, Daignault S, Faerber GJ, McQuire EJ, Latini JM. Long-term
durability and functional outcomes among patients with artificial urinary sphincters: a 10-
year retrospective review form the University of Michigan. J Urol. 2008;179(5):1912-
1916.

19. Knorst MR, Resende TL, Santos TG, Goldim JR. The effect of outpatient physical
therapy intervention on pelvic floor muscles in women with urinary incontinence. Braz J
Phys Ther. 2013;17(5):442-449.

20. Kobata SA, Girao MJ, Baracat EC, et al. Estrogen therapy influence on periurethral
vessels in postmenopausal incontinent women using dopplervelocimetry analysis.
Maturitas. 2008;61(3):243-247.

21. Lang JH, Zhu L, Sun ZJ, Chen J. Estrogen levels and estrogen receptors in patients with
stress urinary incontinence and pelvic organ prolapse. Int J of Gynecol Obstet.
2002;80(1):35-39.

22. Liebergall-Wischnitzer M, Paltiel O, Hochner-Celnikier D, Lavy Y, Shveiky D, Manor

O. Concordance between one-hour pad test and subjective assessment of stress
incontinence. Urol. 2010;76(6):1364-1368.

23. Long CY, Liu CM, Hsu SC, Chen YH, Wu CH, Tsai EM. A randomized comparative
study of the effects of oral and topical estrogen therapy on the lower urinary tract of
hysterectomized postmenopausal women. Fertil Steril. 2006;85(1):155-160.

24
24. Macaluso A, Young A, Gibb KS, Rowe DA, De Vito G. Cycling as a novel approach to
resistance training increases muscle strength, power, and selected functional abilities in
healthy older women. J of Appl Physiol. 2003;95(6):2544-2553.

25. Makinen JI, Pitkanen YA, Salmi TA, Gronroos M, Rinne R, Paakkari I. Transdermal
estrogen for female stress urinary incontinence in postmenopause. Maturitas.
1995;23(2):233-238.

26. Mannella P, Palla G, Bellini M, Simoncini T. The female pelvic floor through midlife and
aging. Maturitas. 2013;76(3):230-234.

27. Middlekauff ML, Egger MJ, Nygaard IE, Shaw JM. The impact of acute and chronic
strenuous exercise on pelvic floor muscle strength and support in nulliparous healthy
women. Amer J Obstet Gynecol. 2016.

28. Moore K. Duloxetine: a new approach for treating stress urinary incontinence. Int J
Gynecol Obstet. 2004;86:S53-S62.

29. Moreno-Vecino B, Arija-Blazquez A, Pedrero-Chamizo R, et al. Associations between

obesity, physical fitness, and urinary incontinence in non-institutionalized
postmenopausal women: the elderly EXERNET multi-center study. Maturitas.
2015;82(2):208-214.

30. National Library of Medicine. Stress urinary incontinence.

https://www.nlm.nih.gov/medlineplus/ency/article/000891.htm. Updated February 2,
2015. Accessed July 10, 2016.

31. Northington GM, de Vries HF, Bogner HR. Self-reported estrogen use and newly
incident urinary incontinence among postmenopausal community-dwelling women.
Menopause: The Journal of the North American Menopause Society. 2012;19(3):290-
295.

32. Norton PG, Zinner NR, Yalcin I, Bump R. Duloxetine versus placebo in the treatment of
stress urinary incontinence. Amer J Obstet Gynecol. 2002;187(1):40-48.

33. Nygaard IE, M Heit. Stress urinary incontinence. American College of Obstetricians and
Gynecologists. 2004;104:607-620.

34. Nyugen A, Aschkenazi SO, Sand PK, et al. Nongenetic factors associated with stress
urinary incontinence. Obstet Gynecol. 2011;117(2):251-255.

35. Pereira VS, Correia GN, Driusso P. Individual and group pelvic floor muscle training
versus no treatment in female stress urinary incontinence: a randomized controlled pilot
study. Eur J Obstet Gynecol. 2011;159(2):465-471.

25
36. Qie J, Lv L, Lin X, et al. Body mass index, recreational physical activity and female
urinary incontinence in Gansu, China. European Journal of Obstetrics & Gynecology and
Reproductive Biology. 2011;159(1):224-229.

37. Riss P, Kargl J. Quality of life and urinary incontinence in women. Maturitas.
2011;68(2):137-142.

38. Saha A, Saha D, Koley AK, Bal R, Dey BC, Chattapadhyay N. Urinary incontinence in
postmenopausal women-a study in urban population. Journal of evolution of medical and
dental sciences. 2013:7096.

39. Sanches PR, Silva Jr. DP, Muller AF, Schmidt A, Ramos JG, Nohama, P. Vaginal probe
transducer: characterization and measurement of pelvic-floor strength.

40. Sansawang B, Serisathien Y. Effect of pelvic floor muscle exercise programme on stress
urinary incontinence among pregnant women. J Adv Nurs. 2012;68(9);1997-2007.

41. Sartori MG, Baracat EC, Girao MJ, Goncalves WJ, Sartori JP, Rodrigues de Lima G.
Menopausal genuine stress urinary incontinence treated with conjugated estrogens plus
progestogens. Int J Gynecol Obstet. 1995;49(2):165-169.

42. Shaw JM, Hamad NM, Coleman TJ, et al. Intra-abdominal pressures during activity in
women using an intra-vaginal pressure transducer. J Sports Sci. 2014;32(12):1176-1185.

43. Stav K, Alcalay M, Peleg S, Lindner A, Gayer G, Hershkovitz I. Pelvis architecture and
urinary incontinence in women. European Urology. 2006;52(1):239-244.

44. Subak LL, Goode PS, Brubaker L, et al. Urinary incontinence management costs are
reduced following Burch or sling surgery for stress incontinence. Am J Obstet Gynecol.
2014;211(2):171e.1-171.e7

45. Townsend MK, Curhan GC, Resnick RM, Grodstein F. The incidence of urinary
incontinence across Asian, black, and white women in the United States. Amer J Obstet
Gynecol. 2014;202(4):378.e1-378.e2

46. Van der Walt I, Bo K, Hanekom S, Rienhardt G. Ethnic differences in pelvic floor
muscle strength and endurance in south African women. Int Urogynecol J. 2014;25:799-
805.

47. Virkud A. Management of stress urinary incontinence. Best Pract Res Clin Obstet
Gynecol. 2011;25(2):205-216.

48. Wing RR, West DS, Grady D, et al. Effect of weight loss on urinary incontinence in
overweight and obese women: results at 12 and 18 months. J Urol. 2010;184(3):1005-
1010.

26
49. Wyman JF, Fantl A, McClish DK, Bump R. Comparative efficacy of behavioral
interventions in the management of female urinary incontinence. Amer J Obstet Gynecol.
1998;179(4):999-1007.

50. Yoon HS, Song HH, Ro YJ. A comparison of effectiveness of bladder training and pelvic
muscle exercise on female urinary incontinence. International Journal of Nursing
Studies. 2003;40(1):45-50.

51. Zinner NR. Stress urinary incontinence in women: efficacy and safety of duloxetine.
European Urology Supplements. 2005;4(1):29-37.

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