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The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
This is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years from the initial drug treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridium Histolyticum Collagenase | Drug | 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Complication After Treatment | Number of subjects with complication after treatment with clostridium histolyticum collagenase | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Needing Further Intervention for Treatment of Urethral Stricture | Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture. | 2 years |
| Number of Subjects With Recurrence of Urethral Stricture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas R Wiegand, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida - South Tampa Campus | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17437780 | Result | Santucci RA, Joyce GF, Wise M. Male urethral stricture disease. J Urol. 2007 May;177(5):1667-74. doi: 10.1016/j.juro.2007.01.041. | |
| 21315996 | Result | Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. Clostridium Histolyticum Collagenase: 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring. Saline: 0.08ml of injectable normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 subjects enrolled in study, certain baseline data is available for only 4 subjects. One subject withdrew consent before all baseline visit procedures were completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. Clostridium Histolyticum Collagenase: 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring. Saline: 0.08ml of injectable normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Complication After Treatment | Number of subjects with complication after treatment with clostridium histolyticum collagenase | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Posted | Count of Participants | Participants | 84 days |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Patients will undergo instillation of local anesthesia (20 mL of 2% urethral lidocaine jelly), the patient will undergo cystoscopy, transurethral injection (via a 70 cm 4.8 Fr flexible cystoscopic needle with a 23 gauge needle tip manufactured by Laborie®, Ontario, Canada) of 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. Clostridium Histolyticum Collagenase: 0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring. Saline: 0.08ml of injectable normal saline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
These are first-in-human cases with collagenase clostridium histolyticum (CCH) treatment for urethral stricture, although number of treated patients is low. Future directions will hopefully include increased sample size through multi-institutional participation and adjunctive procedures designed to augment the proposed beneficial effects of CCH therapy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucas Wiegand, MD | University of South Florida | 813-844-5972 | lwiegand@usf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2021 | Jul 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| Saline | Other | 0.08ml of injectable normal saline |
|
|
Number of subjects with recurrence of urethral stricture |
| 2 years |
| Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | 6 weeks |
| Change From Baseline and 6 Months: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | 6 months |
| Change From Baseline and 9 Months: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | 9 months |
| Change From Baseline and 12 Months: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | 12 months |
| Change From Baseline and 2 Years: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | 2 years |
| Time to Urethral Stricture Recurrence | 2 years |
| Time to Additional Intervention for Urethral Stricture | 2 years |
| Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | 6 weeks |
| Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | 6 months |
| Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | 9 months |
| Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | 12 months |
| Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | 18 months |
| Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | 2 years |
| Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | 6 weeks |
| Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | 6 months |
| Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | 9 months |
| Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | 12 months |
| Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | 18 months |
| Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | 2 years |
| 9679876 | Result | Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5. |
| 15541123 | Result | Hussain M, Greenwell TJ, Shah J, Mundy A. Long-term results of a self-expanding wallstent in the treatment of urethral stricture. BJU Int. 2004 Nov;94(7):1037-9. doi: 10.1111/j.1464-410X.2004.05100.x. |
| 24745607 | Result | Zhang K, Qi E, Zhang Y, Sa Y, Fu Q. Efficacy and safety of local steroids for urethra strictures: a systematic review and meta-analysis. J Endourol. 2014 Aug;28(8):962-8. doi: 10.1089/end.2014.0090. Epub 2014 Jun 3. |
| 26491251 | Result | Peak TC, Mitchell GC, Yafi FA, Hellstrom WJ. Role of collagenase clostridium histolyticum in Peyronie's disease. Biologics. 2015 Sep 29;9:107-16. doi: 10.2147/BTT.S65619. eCollection 2015. |
| 23376148 | Result | Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31. |
| 17617144 | Result | Cavalcanti AG, Costa WS, Baskin LS, McAninch JA, Sampaio FJ. A morphometric analysis of bulbar urethral strictures. BJU Int. 2007 Aug;100(2):397-402. doi: 10.1111/j.1464-410X.2007.06904.x. |
| 26126692 | Result | Sangkum P, Yafi FA, Kim H, Bouljihad M, Ranjan M, Datta A, Mandava SH, Sikka SC, Abdel-Mageed AB, Moparty K, Hellstrom WJ. Collagenase Clostridium histolyticum (Xiaflex) for the Treatment of Urethral Stricture Disease in a Rat Model of Urethral Fibrosis. Urology. 2015 Sep;86(3):647.e1-6. doi: 10.1016/j.urology.2015.06.013. Epub 2015 Jun 27. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Stricture length | The stricture length was determined via high-frequency ultrasound with lubricant instilled per urethra to delineate the urethral lumen and then measuring the maximum distance from normal diameter lumen to normal diameter lumen in a sagittal plane. | Mean | Standard Deviation | cm |
|
| Post void residual urine | Post void residual urine (amount of urine that remains after urination) was measured via Laborie Portascan 3D ultrasound per standard clinical protocol immediately post-void. | One subject withdrew consent before all baseline procedures were completed, data not available for that subject | Mean | Standard Deviation | mL |
|
| Uroflowmetry | Uroflowmetry was measured as the maximum flow rate as recorded via Laborie Urocap weight-based evaluation on a urine volume of at least 50mL as per standard clinical protocol. | One subject withdrew consent before all baseline procedures were completed, data not available for that subject | Mean | Standard Deviation | mL/s |
|
| Length of spongiofibrosis | The length of spongiofibrosis was determine via high-frequency ultrasound with lubricant instilled per urethra to delineate the urethral lumen and then measuring the distance from normal-appearing spongiosal tissue to normal appearing tissue, traversing the structured segment, as determined by the investigator based on the echotexture. | One subject withdrew consent before all baseline procedures were completed, data not available for that subject | Mean | Standard Deviation | cm |
|
| Urethral stricture grade 2 | Urethral stricture was graded based on ultrasound findings ranging from Grade 1 (short stricture with minimal spongiosal tissue involvement) to Grade 5 (full thickness/severe spongiosal involvement and at least 2 cm stricture length). Urethral stricture Grade 2 was short stricture with moderate spongiosal tissue involvement | One subject withdrew consent before all baseline procedures were completed, data not available for that subject | Count of Participants | Participants |
|
| American Urological Association symptom score | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | Mean | Standard Deviation | scores on a scale |
|
|
|
| Secondary | Number of Patients Needing Further Intervention for Treatment of Urethral Stricture | Further intervention - defined as any medical or surgical intervention for treatment of urethral stricture. | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Subjects With Recurrence of Urethral Stricture | Number of subjects with recurrence of urethral stricture | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Change From Baseline and 6 Weeks: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 weeks follow-up. | Posted | Mean | Standard Deviation | scores on a scale | 6 weeks |
|
|
|
| Secondary | Change From Baseline and 6 Months: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 months follow-up. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline and 9 Months: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 9 months follow-up. | Posted | Number | scores on a scale | 9 months |
|
|
|
| Secondary | Change From Baseline and 12 Months: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 12 months follow-up. | Posted | Number | scores on a scale | 12 months |
|
|
|
| Secondary | Change From Baseline and 2 Years: American Urology Association Questionnaire Scores | The American Urology Association questionnaire score is totaled based on 7 questions. Each question asks the subject to rate their symptom on a 5-point scale from "Not at All" (0) to "Almost Always" (5). The total score is based on adding rating marked for each question. The total runs from 0 to 35 points with higher scores indicating more severe symptoms. | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 2 years follow-up. | Posted | Number | scores on a scale | 2 years |
|
|
|
| Secondary | Time to Urethral Stricture Recurrence | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. None of the treated subjects had recurrence of urethral stricture. | Posted | 2 years |
|
|
| Secondary | Time to Additional Intervention for Urethral Stricture | Only 3 subjects were treated with study treatment. Two subjects withdrew prior to receiving study treatment. | Posted | Median | Full Range | months | 2 years |
|
|
|
| Secondary | Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 weeks follow-up. | Posted | Mean | Standard Deviation | mL/s | 6 weeks |
|
|
|
| Secondary | Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 months follow-up. | Posted | Mean | Standard Deviation | mL/s | 6 months |
|
|
|
| Secondary | Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 9 months follow-up. | Posted | Number | mL/s | 9 months |
|
|
|
| Secondary | Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 12 months follow-up. | Posted | Number | mL/s | 12 months |
|
|
|
| Secondary | Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 18 months follow-up. | Posted | Number | mL/s | 18 months |
|
|
|
| Secondary | Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Uroflow) | Obstructive voiding dysfunction defined as change in uroflow | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 2 years follow-up. | Posted | Number | mL/s | 2 years |
|
|
|
| Secondary | Change From Baseline and 6 Weeks: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 weeks follow-up. | Posted | Mean | Standard Deviation | mL | 6 weeks |
|
|
|
| Secondary | Change From Baseline and 6 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 2 out of 3 treated subjects completed 6 months follow-up. | Posted | Mean | Standard Deviation | mL | 6 months |
|
|
|
| Secondary | Change From Baseline and 9 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 9 months follow-up. | Posted | Number | mL | 9 months |
|
|
|
| Secondary | Change From Baseline and 12 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 12 months follow-up. | Posted | Number | mL | 12 months |
|
|
|
| Secondary | Change From Baseline and 18 Months: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 18 months follow-up. | Posted | Number | mL | 18 months |
|
|
|
| Secondary | Change From Baseline and 2 Years: Obstructive Voiding Dysfunction (Post-void Residual Measurements) | Obstructive voiding dysfunction defined as change in post-void residual measurements | Two subjects withdrew prior to receiving study treatment. Only 3 subjects were treated with study treatment. Only 1 out of 3 treated subjects completed 2 years follow-up. | Posted | Number | mL | 2 years |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Worsening of urethral stricture | Renal and urinary disorders | Non-systematic Assessment |
|
| Post void dribbling | Renal and urinary disorders | Non-systematic Assessment | Reported at 2 years follow-up |
|
| Right thigh pain | Renal and urinary disorders | Non-systematic Assessment | Following standard of care foley placement |
|
Not provided
Not provided
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |