InexpensiveMicrobubbles,thekeyinthe ContrastEnhancedSonographic EvaluationofStricturesintheMale AnteriorUrethraTheEastAvenue MedicalCenterComparativeExperience

RogelioF.VarelaJr.MDa;LeeMartinA.JaranillaMDb;LesterAGarciaMDFPUAa;PoncianoBernardo MDFPUAa;Ma.AsuncionRelampagosNavoa,MD,FPCRb a DepartmentofUrology b DepartmentofRadiologicalSciences EastAvenueMedicalCenter,Philippines

Abstract
Introduction: Men aged 16-68 diagnosed with anterior urethral stricture from January to March 2011 was identified. Methodology: All Subjects were given prophylactic antibiotics (Ciprofloxacin 500mg) and were subjected to Retrograde Urethrogram. Ultrasound with Saline solution, saline with turbulence, Ultrasound with Sparkling water, and sparkling water with turbulence was done. The location of the stricture for each of the patient and the degree of patency of the strictured segment was measured and compared with Retrograde Urethrogram. Results: tests employing the production of bubbles which included infusion of saline with turbulence, sparkling water, and sparkling water with turbulence detected the strictured site and the degree of patency as well as RUG (Kappa test signif= 0.000 and anova p= 0.96502). Using saline alone however will fail to detect the actual strictured sites especially if those sites are still patent and are located in the bulbous urethra (Kappa test signif= 0.670 + 0.151 sensitivity= 66.7% and specificity=100%) Conclusion: saline water with turbulence and sparkling water with or without turbulence can be used as alternative contrast materials in the evaluation of strictures in the anterior urethra. Keywords: Anterior Urethral Stricture, Sonographic Contrast, Microbubble Contrast

INTRODUCTION Urethral stricture is a common disease entity seen by most Urologists in the clinics. It has been described in several Greek and Egyptian literatures in the past1.

Obstructive voiding symptoms found among patients with stricture remain the typical reason for evaluating urethral stricture disease6. Data from the United States and United Kingdom showed that it affects males with an increasing frequency with one in every 10,000 med aged 25 to about one in every 1000 males aged 65 or more2. Data from the Sindh Institute of Urology and Transplantation (SIUT), shows that stricture disease constitutes 3-4% of all urologic diseases and 5760 patients visit annually for dilatation, other treatment options and follow-up uroflowmetry. In 2006, two hundred and seventy four indoor admissions were due to stricture urethra in the same Institute3. Any process that injures the urethral epithelium or the underlying corpus spongiosum to the point that healing results in a scar can result to the development of anterior urethral stricture. It is not a primary disease but an end-result of multiple factors4. Infection, particularly gonoccocal urethritis has been the most commonly implicated cause. Other etiologies are listed on Table 1 on the appendix section. Review of related literature The male urethra is divided into two segments by the urogenital diaphragm the anterior urethra, which is composed of the penile or pendulous and the bulbous urethra; and the posterior urethra composed to the prostato-membranous urethra5. The pendulous and bulbar urethra may vary in its length. The prostatic urethra measures at about 3cm in length while the membranous urethra measures at 1cm. It is eccentrically placed in relation to the corpus spongiosum in the bulbous urethra and is much closer to the dorsum of the penile structures. As one moves distally, the pendulous or penile urethra becomes more centrally placed within the corpus spongiosum. Radiographic imaging is an essential part in the diagnosis and surgical planning of urethral strictures. In addition to classic retrograde and antegrade urethrography some centers now use intra urethral ultrasound and MRI to define the extent of urethral injury and fibrosis.3 Posterior urethral injuries, which is commonly observed among patients who sustained pelvic fractures secondary to deceleration injuries (motor vehicle accidents, fall, blunt trauma) has been identified using either RUG or MRI. Disruption of the prostate from its connection to the anterior urethra at the prostatic apex has been observed. Even in the advent of modern radiographic imaging, retrograde urethrogram remains to be the diagnostic imaging of choice for urethral stricture6. Several techniques has been described on the use of retrograde urethrogram. The foley catheter technique, which has been described by Sandler, requires the use of foley catheter 16-F inserted into the meatus, at about 2 to 2.5 cm proximal to the meatus. It is secured in the fossa navicularis by filling the balloon to about one to two millilitres of saline solution. The use of lubricants are generally avoided since it may promote dislodgement of the foley catheter from its place. The patient is placed in the

25- to 35-degree oblique position and a radiographic exposure is made during the injection of 25 to 30 ml of contrast material. This oblique position is preferred since a antero-posterior position will foreshorten or superimposed the bulbous urethra5. Used alone, the present diagnostic modalities of ultrasonography, CT scan, and MRI have not yet been proven to be adequate if and are not commonly used for the primary diagnosis of urethral trauma7,9 . Recent information is scarce, but there have been a few articles suggesting that ultrasonography has been successfully used in describing the extent of urethral damage and has been used in the preparation and planning for surgical repair.10, 11 They used sonography to diagnose urethral trauma associated with penile fracture and in evaluating anterior urethral trauma prior to delayed urethroplasty. They have shows that sonography can accurately depict trauma to soft tissues surrounding the urethra, such as the tunica albuginea.10 Some other authors have shown that sonourethrography is more accurate in measuring stricture length than RUG. They have also demonstrated that ultrasound can be useful in demonstrating hematoma size and is good at describing fluid extravasation. 8 Since 1988 when it was originally described by McAninch, ultrasound imaging of the urethra has become a powerful clinical tool to accurately define urethral pathology. The advent of high frequency probes has proved that sonourethrography is more sensitive than conventional radiography of the urethra. It has a high spatial resolution and has proved to be sensitive, specific, and accurate in the diagnosis and assessment of pathologies in the anterior urethra, such as strictures, syringocele, tumors, and trauma.7, 12 Ultrasound of the male urethra is a simple technique that gives a flexible but precise assessment of anterior urethral strictures. Authors have noted that it is best used to stage men with known symptomatic strictures for whom the need for surgery is unclear. Ultrasound was found to be more accurate in measuring stricture length than conventional RUG for short short bulbar strictures, aiding in the descision wether to excise, to dilate, or to graft. In Long complex strictures is useful to assess the stricture's diameter aiding in the descision as to the flap width and in recognizing focal urethral segments to be excised. 13 Injection of a saline solution has enabled ultrasound to study the anatomy of the urethra in detail. This includes the infusion of saline solution thru a Foley catheter in a similar manner as described for RUG to promote distension of the urethra. This then creates good contrast relative to the urethral mucosa allowing for an accurate visualization of the urethral wall and lumen.8 However, posterior urethral and peri-urethral fibrosis cannot be reliably assessed using this technique.12 Studies have described better assessment of urethral strictures using ultrasonography compared with the current gold standard of Retrograde urethrography (RUG). 14,15,16 The use of sonographic contrast, in the form of microbubbles, used intraurethrally has also been described to produce improved the definition of long narrow strictures.16

It is the simple, precise, and readily available characteristic of ultrasound with no risk for radiation exposure that drove the authors to be the first to assess if sonourethrography can be adapted and viably used at our institution as a valuable tool in assessing the anterior male urethra. With previous reports stating that the presence of bubbles within a solution that is being infused creates contrast on ultrasound, we want to evaluate if we can find local products that has an inherent capacity of producing bubbles and can be safely used intra-urethrally. Carbonated water or sparkling water inherently produces bubbles when poured. We surmise that we can chose the most available brand of carbonated water and test it if we can safely use it as contrast for our patients with stricture. Another option was to device a way to infuse saline that will enable it to produce bubbles. This can be done by infusing saline thru a small tube that goes into a larger tube creating in turbulence and in turn creating bubbles. PROBLEM: With the very high cost of the current microbubble contrast in ultrasonography, can cheaper alternatives be used in the real time sonographic evaluation of anterior urethral stricture? OBJECTIVES: GENERAL: Identify whether sparkling water and/ or normal saline infused in a way that produces bubbles can serve as alternative sonographic contrast material in the evaluation of the lower urinary tract. SPECIFIC: 1. Identify if the retrograde infusion of Sparkling Water, normal saline, and saline with turbulence into the lower urinary tract is clinically safe. 2. Determine if the retrograde infusion of Sparkling Water, normal saline, and saline with turbulence into the lower urinary tract can identify anterior urethral stricture. SUBJECTS: INCLUSION CRITERIA: 1. Only male patients from 16 age to 68 who consented to the procedure were included. To ensure a homogenous group of patients, only those who were previously documented and diagnosed with anterior urethral strictures were included from January 2011 to March 2011. 2. 8 patients previously diagnosed with strictures were included into the positive group of patients.

3. 3 normal volunteers who have not previously been diagnosed or show symptoms of any lower urinary tract pathology were included and lumped into the negative group of patients. 4. All 11 patients were required to submit specimens for urinalysis the results of which were unremarkable. EXCLUSION CRITERIA: 1. All patients currently with urinary tract infection as documented by urinalysis prior to the study. 2. All patients currently with open wounds/ bleeding that may involve the urethra and the urinary bladder. 3. All patients with stricture due to trauma in whom extravasation of contrast material into the peri-urethral soft tissues was previously documented by retrograde urethrography. 4. All known patients with prostatic cancer. 5. Physiologically unstable, comatose, or unconscious patients 6. Presently with acute urethral injury MATERIALS AND METHODOLOGY: Materials: In choosing the particular brand of sparkling water for use in this study, the two most available brands classified as being naturally obtained, or those from melting glacier ice, were included. As printed on its manufacturing ingredients, only the ones that contained carbonated water only with no sugar or any other additive were included. A bottle of each brand was then randomly obtained from two different and randomly selected supermarkets and sent for water analysis and culture. They were likewise randomly obtained to show that any unopened bottle from these manufacturers from any supermarket or retailer was satisfactory for use by any patient. The most available natural sparkling water in the market at the time of the study were under the brand names of Perrier and El Pelligrino sparkling water. An unopened bottle from each brand was bought from different supermarket/ stores and sent for water analysis and culture. Both brands were deemed without coliform and did not yield any growth after 3 days of culture. Fresh unopened Plain normal saline (0.9% NSS) as packed in plastic IV containers at the emergency rooms were also sent for culture as a negative control. Only the cheaper brand of sparkling water that passed water analysis and culture was used. Forty unopened bottles of the preselected brand (Perrier) that passed

analysis were then stored at 4-8 degrees Celsius prior to use. They were pre-warmed to room a body temperature of 36 degree prior use. To create turbulence with the infusion of saline, about 2 cm of F8 feeding tubes were connected to 50 ml syringes. This set up was then placed into a F16 foley catheter which was used to infuse the saline into the urethra. Ultrasound Contrast instillation Written consent was obtained together with a verbal explanation of the procedure, the materials to be used, and the risks involved were explained to the patient. Retrograde urethrography was done according to the foley catheter technique of Sandler was done on all patients as follows: We inserted a 16-F foley catheter 16-F inserted into the meatus, at about 2 to 2 cm proximal to the meatus. It is secured in the fossa navicularis by filling the balloon to about one to two millilitres of saline solution. The use of lubricants are generally avoided since it may promote dislodgement of the foley catheter from its place. The patient is placed in the 25- to 35-degree oblique position and a radiographic exposure is made during the injection of 25 to 30 ml of contrast material (conray). This oblique position is preferred since a antero-posterior position will foreshorten or superimposed the bulbous urethra5. A single-blind randomized selection of the patients was done, wherein the sonologist to do the procedure and his assist were unaware of the positive or negative classification by RUG of the patient. We similarly infused the saline, saline with turbulence, and sparkling water as we have infused contrast in RUG. The patient is laid supine comfortably placed in the 25- to 35-degree oblique position. The meatus of the glans penis is gently cleansed with betadine as an antiseptic. A foley catheter F16 is inserted into the meatus, about 2 to 3 mm proximal to the meatus. It is secured in the fossa navicularis by filling the balloon to about one to two millilitres of saline solution. The use of lubricants are generally avoided since it may promote dislodgement of the foley catheter from its place. A 50 ml syringe filled with normal saline solution is placed into the foley catheter and a bolus of 5 ml was gently manually pushed at a rate of about 0.5 ml per second. To document the penile, bulbous, membranous portions of the urethra, an ultrasound probe is then used to trace in a retrograde manner areas of stricture from urethral meatus, the penile and the membranous urethra. This was done by placing a linear ultrasound probe (L12-3 probe using a HD6 Philips ultrasound machine) superficially at the inferior midline aspects of the penis and the perineum. In areas where strictures were clearly noted, the location of the stricture in relation to the urethral segment was identified. The diameter of the stricture was then measured divided by the segment of the normal urethral diameter distal to the stricture. The resulting quotient

was then multiplied by 100 to convert the degree of patency into percentage. This was done to negate the effect magnification had on the RGU image. A total of 4 test solutions was infused using the above procedure: 1. Normal saline using an asepto-syringe (50 ml). 2. Normal saline into a 2 cm F8 feeding tube that is inside a F16 foley catheter. As described above, to create turbulence and bubbles. 3. Sparkling water using an asepto-syringe (50 ml). 4. Sparkling water (Perrier) into a 2 cm F8 feeding tube that is inside a F16 foley catheter. As described above, to create turbulence and smaller bubbles. Antibiotic Prophylaxis Each Patient was given ciprofloxacin 500 mg/ tab (a quinolone) as antibiotic regimen TID for 3 days after the procedure. Results and analysis of data: Table 1.0
pxno. 1 2 3 4a 4b 5 6 7 8 9 10 11 age 68 16 28 44 44 32 19 36 33 21 21 30 diagnosis straddleinjury straddleinjury straddleinjury straddleinjury straddleinjury postinfxn straddleinjury straddleinjury postinfxn unremarkable unremarkable unremarkable

A total of 11 patients who volunteered and passed the criteria were evaluated. Their ages ranged from 16 to 68 years old, most of whom had anterior urethral injury due to trauma. Patient number 4 had two point strictures, one was at the proximal third portion of the penis, while the other was in the bulbous urethra. Table 2.0
stricture location (RGU) bulbous bulbous Sparkling water 1 1 1 1 sparkling + Turb 1 1

pxno.

diagnosis straddle 1 injury 2 straddle

NSS 1 0

nss+Turb

3 4a 4b 5 6

bulbous proximal 7 penile proximal 8 postinfxn penile 9 unremarkable unremarkable 10 unremarkable unremarkable 11 unremarkable unremarkable

injury straddle injury straddle injury straddle injury postinfxn straddle injury straddle injury

bulbous proximal penile bulbous penile

1 1 0 1 0 1 1 1 1 1

1 1 1 1 1 1 1 1 1 1

1 1 1 1 1 1 1 1 1 1

1 1 1 1 1 1 1 1 1 1

Legend: 0 actual stricture site was not detected. 1 stricture site was detected

Table 2.0 states that all the tests which included the instillation of contrast into the urethra detected the correct stricture site just as it was detected in RUG. However, plain saline solution only detected the specific region of the stricture but detected a tubular structure which was assumed by the sonologist as the stricture site but was not where the bubbles went when sonologic contrast was used. This was proven when the Kappa test was used on the tests as stated below Stat table 1.1 NSS vs RGU Measure agreement kappa No. of cases value of K=0.670+ 0.151 P=0.000 valid 12

This test states that using plain NSS without contrast in sonourethrography would tend to miss some of the cases especially in those whom the stricture still allows some urine to pass thru and not completely stenosed. And based on table 2.0, this appears to be in the bulbous urethra, wherein the sonologist assumed a different anechoic orifice compared with those seen in Retrograde urethrography or when using bubble contrast. We assumed this to have been the duct for skenes gland. Saline however, is excellent in detecting stricture sites in the penile/ pendulous urethra. Stat table 1.2 NSS vs. RGU RGU + RGU -

NSS + NSS -

6 3

0 3

Sensitivity = 66.7% - using NSS alone will not correctly identify and miss the actual site of stricture 1/3rd of the time Specificity = 100 % - however, it will correctly identify all the negative patients. PPV = 100% - positive predictive value NPV = 50% - negative predictive value

Stat table 2.0 Saline with turbulence vs. RGU value Measure agreement kappa No. of cases of 1.000 Asymptomatic Std error 0.0000 Approx T 4.846 Approx sig. 0.000

valid 12

Stat table 3.0 Sparkling water vs. RGU value Measure agreement kappa No. of cases of 1.000 Asymptomatic Std error 0.0000 Approx T 4.846 Approx sig. 0.000

valid 12

Stat table 4.0 Sparkling water with Turbulence vs. RGU value Measure agreement kappa No. of cases of 1.000 Asymptomatic Std error 0.0000 Approx T 4.846 Approx sig. 0.000

valid 12

Stat tables 2.0 to 4.0 using the kappa test states that these three proposed ultrasound contrast materials detected the stricture site as they were seen in RGU Table 3.0 degrees of Patency of each proposed contrast media vs. RGU
pxno. 1 2 3 4a 4b 5 6 7 8 pxno. 1 NSS + Turbulence RGUpatency(%) patency(%) SWpatency(%) 0% 0% 0% 25% 26.05% 23.45% 12.50% 10.36% 10.00% 27.27% 28.98% 36.65% 8% 12.59% 19.61% 16.70% 16.47% 14.30% 16% 20% 23% 0% 0% 0% 0% 0% 0% NSS + Turbulence RGUpatency(%) patency(%) SWpatency(%) 0% 0% 0% SW + Turbpatency (%) 0% 18.50% 11.49% 21.64% 14.68% 15.53% 24% 0% 0% SW + Turbpatency (%) 0%

To standardize data and to rule out the effect of magnification on the RGU image, table 3.0 was computed as follows: In areas where strictures were clearly noted, the location of the stricture in relation to the urethral segment was identified. The diameter of the stricture was then measured divided by the segment of the normal urethral diameter distal to the stricture. The resulting quotient was then multiplied by 100 to convert the degree of patency into percentage. It can be grossly noted here that the values do not differ much from each other. This was proven when a one way anova was done on the percent patency of the stricture sites. Data Summary N Sum Mean Sumsq SS Variance st. dev. Xa 9 105.47 11.7189 Xb 9 114.45 12.7167 Xc 9 127.01 14.1122 Xd 9 105.84 11.76 Total 36 452.77 12.5769 9665.7445 3971.2814 113.4652 10.652

2123.7929 2455.5415 3111.1671 1975.243 887.8017 110.9752 10.5345 1000.119 125.0149 11.181 1318.7738 730.5646 164.8467 12.8393 91.3206 9.5562

Variances and standard deviations are calculated with denominator = n-1.

ANOVA Summary Source bg wg Total SS 34.0223 3937.259 df 3 MS 11.34 F P 0.09 0.965022

32 123.04

3971.2814 35

bg = between groups; wg = within groups (error) A p-value of 0.965022, means that these percentage of patencies were not significantly different from each other compared with those seen in RGU. Summary and Conclusions: This study proves that using either normal saline with turbulence or sparkling water as contrast materials in ultrasonography have an almost equal rate of detecting strictures in the male urethra as the current gold standards of RGU. The most important factor is that bubbles should be seen to go into the strictured segments This study therefore concludes that: By using readily available materials, Using normal saline with turbulence and/or sparkling water as ultrasound contrast materials are just as sensitive and specific as using RGU. We just have to create bubbles. Future applications: 1. The methodology using sparkling water and normal saline with turbulence as ultrasound contrast can be used to document pre and post-operative changes in urethral obstruction. 2. Once the stricture site is identified, future studies can use our protocol to measure the length and thickness of the strictured segments to aid surgeons as they plan for the management of the patient. 3. Since using the same methodology provides more data, the use of sparkling water and/ or normal saline with turbulence as contrast in ultrasonography can be used to aid or perhaps even replace RGU in selected patients. 4. Clinicians can use our protocol to estimate degree of obstruction by ultrasound and compare it with what they see surgically. Recommendations: 1. A study using urethroscopy can be done to compare and determine the accuracy of the above findings with actual clinical results.

2. A similar study using our protocol can be done to evaluate patients with posterior urethral obstruction 3. Using the above protocol, future studies can create a better and improved clinical criteria which can be compared with the degree of patency of the strictured segment.

REFERENCES 1 Attwater HL. History of urethral stricture. Br J Urol 1943; 15 : 39 2 Andrich D.E., Mundy A.R., Urethral strictures and their surgical treatment. BJU Int. 2000; 86: 571-80. 3 Manzoor H Urethral stricture disease: An old disease with newer treatments J Pak Med Assoc Vol. 58, No. 5, May 2008 4 Walsh, PC et.al Campbells Urology 7th Edition W.B. Saunders Company Copyright 1998 pp.3343 5 Sandler CM Urethrography in the Diagnosis of Acute Urethral Injuries The Urol Clin of N America 1989 16:2 283-289 6 Peterson A Management of urethral stricture disease: developing options for surgical intervention BJU Int 2004; 94: 971976 7 Pavlica P, Barozzi L, Menchi I. Imaging of male urethra. Eur Radiol. Jul 2003;13(7):158396. [Medline]. 8 Pavlica P, Menchi I, Barozzi L. New imaging of the anterior male urethra. Abdom Imaging. Mar-Apr 2003;28(2):180-6. [Medline]. 9 Riccabona M. Contrast ultrasound of the urethra in children. Eur Radiol. Jul 2003;13(7):14945. [Medline]. 10 Forman HP, Rosenberg HK, Snyder HM 3rd. Fractured penis: sonographic aid to diagnosis. AJR Am J Roentgenol. Nov 1989;153(5):1009-10. [Medline]. 11 Bearcroft PW, Berman LH. Sonography in the evaluation of the male anterior urethra. Clin Radiol. Sep 1994;49(9):621-6. [Medline]. 12 Morey AF, McAninch JW. Ultrasound evaluation of the male urethra for assessment of urethral stricture. J Clin Ultrasound. 1996 Oct;24(8):473-9. 13 Gallentine ML, Morey AF. Imaging of the male urethra for stricture disease. Urol Clin North Am. 2002 May;29(2):361-72. 14 Babnik Peskar D, Visnar Perovic A. Comparison of radiographic and sonographic urethrography for assessing urethral strictures. Eur Radiol. 2004 Jan;14(1):137-44. Epub 2003 Sep 20. 15 Gupta N, Dubey D, Mandhani A, Srivastava A, Kapoor R, Kumar A. Urethral stricture assessment: a prospective study evaluating urethral ultrasonography and conventional radiological studies. BJU Int. 2006 Jul;98(1):149-53. 16 Akano AO. Evaluation of male anterior urethral strictures by ultrasonography compared with retrograde urethrography. West Afr J Med. 2007 Apr-Jun;26(2):102-5.

Appendix A

PATIENTS DATABASE

Name

Age:

Sex:

Birthday

Address

Diagnosis

Medications

Follow-up Visits

Appendix B
CONSENT FORM
Study Name EVALUATION OF THE ANTERIOR URETHRA WITH RETROGRADE
URETHRAL SONOGRAPHIC STUDIES (RUSS) WITH THE USE OF SPARKLING WATER AND PLAIN NORMAL SALINE SOLUTION AS SONOGRAPHIC CONTRAST IN PATIENTS WITH URTHERAL STRICTURE

Study Sponsor None Prinicipal Rogelio F Varela Jr MD Investigator Lee Martin Jaranilla MD You are being invited to participate in a research study. This consent form has information to help you decide if you want to participate. Take your time, read this form carefully and ask the study doctor or staff for any questions that you have. About this study: The purpose of this study: To know whether the use of sparkling water as a sonographic contrast material can identify anterior urethral stricture as good as compared to the standard retrograde urethrogram. Presently, the Retrograde Urethrogram is the diagnostics of choice for Anterior Urethral Strictures. The use of a sonographic contrast material is a novel procedure for this disease entity. Are there reasons why I may not be allowed to take part in the study? There may be reasons why you are not allowed to take part in this study. Some of these reasons are as follows: 1. Acute urethral injury 2. Urinary Tract Infection 3. Hematuria 4. Physiologically unstable, comatose, moribund patients 5. Azotemia What will I be asked to do? If you take part in this study, you will need the following:

1. Visit the study doctor on scheduled follow-up 2. History and Physical Examination will be done 3. Baseline CBC and urinalysis will be requested What will happen during the study visits? When you come for your study visits, the study doctor or staff may do any or all of the following: 1. Review your medical history 2. Perform a physical examination 3. Check your vital signs 4. Review all laboratory results 5. Prophylactic antibiotics are prescribed What effects could the test have on me? You may feel discomfort during the initial visits for some of the baseline tests. The retrograde instillation of the contrast material, saline solution and the sparkling water may cause pain and discomfort upon infusion. What side effects could the examination cause? You may develop urethritis after the procedure Additional Information You Need to Know If I am injured due to the study drug, who will pay for the doctor and hospital bills? If you are directly injured from the study drug, the study doctor will pay for the reasonable costs of the medical treatment. No other form of compensation is available. What benefit could there be for taking part in the study? The study aims to identify the role of sparkling water in assessing the anterior urethra for strictures. There are no additional benefits except that the information learned from the study may help other people in the future. What are my options if I am not in the study? Your options include:

1. Retrograde Urethrogram 2. Definitive Surgical Intervention How will my privacy be protected? If you decide to be in this study, the study doctor and research team will use health data about you7 to conduct this study. This may include your name, address, phone number, medical history and information from your visits. If possible, the health data will not identify you by name. Instead, it may include your initials, date of birth and study visit dates. The study doctor may use your health data: 1. To see if the diagnostic intervention works and is safe 2. For other activities related to this study Will I be paid? For participation in the study, all interventions needed for the study will be free of charge (Retrograde urethrogram, ultrasound, contrast materials, etc.) Other laboratory work up (CBC, Urinalysis) will be paid by you. Who do I call If I have questions? If you have questions about this study or you have any study related injury, call the study doctor:

Dr Rogelio F Varela 0922-8852571 Department of Urology East Avenue Medical Center Tel No 9282410 Dr. Lee Martin Jaranilla 0922-8286071 Department of radiological Science East Avenue Medical Center Tel No. 9280611

By signing below, I agree to participate in this study: I have read this consent form. I have the chance to ask questions and they have been answered.

I understand that taking part in this study is voluntary. I give permission o use and share my health data as described in this form. I may choose no to be in the study or to leave the study at any time by telling the study doctor. I will not be penalized or lose benefits to which I am otherwise entitled. I may have to leave the study without my consent if I need other treatment, do not follow te study plan, have a study related injury, or for any other reason. If I leave the study for any reason, the study doctor may ask me to have some end of study tests and study staff may call me periodically I will receive a signed copy of this consent form

____________________ Printed Name of Volunteer

__________________ Signature

_______________ Date

(Volunteers legally authorized representative)

Representatives authority to act for volunteer: ______________________________________________ (Parent/Guardian or others)

____________________ Printed name of witness

__________________ Signature

_______________ Date

____________________ Printed Name of person conducting review of person

__________________ Signature

_______________ Date