Functional Outcome of Urethral Reconstructive Surgery

Completed

• Conditions: Urethral Stricture
• Interventions: Procedure: end-to-end urethroplasty; Procedure: substitution urethroplasty (buccal mucosa); Procedure: substitution urethroplasty (pedicled skin flap)

• Registration Number: NCT01982136
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.

Detailed Description

Urethroplasty is the surgical repair of a urethral stricture. Depending on the location, severity and length of the stricture, various techniques can be performed.

The first procedure consists of the excision of the stenotic segment and end-to-end anastomosis. Other procedures consist of widening the urethra with buccal mucosa as free graft or with vascularized (genital) skin flaps. The results of these techniques have been described in prospective cohort studies, but to date there is little good data about the functional outcome and quality-of-life with longer follow-up after this surgery.

The purpose of this study is to prospectively follow patients for functional outcome parameters and quality-of-life to obtain long-term information concerning these surgeries.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 175

Inclusion Criteria

• male
• urethral stricture surgery
• informed consent

Exclusion Criteria

• loss of follow-up
• not willing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urethral stricture	substitution urethroplasty (buccal mucosa)	patients requiring surgery for urethral stricture
Urethral stricture	end-to-end urethroplasty	patients requiring surgery for urethral stricture
Urethral stricture	substitution urethroplasty (pedicled skin flap)	patients requiring surgery for urethral stricture

Primary Outcome Measures

Name	Time	Method
Quality Of Life: change from baseline (=preoperative value)	6m, 1y, 2y, 3y, 4y	Validated questionnaires (patient reported outcome measures) concerning general discomfort, micturition problems, erections, and the impact of those problems on their social life.; * International Prostate Symptom Score - Quality of Life questionnaire (IPSS-QOL); * International Consultation of Incontinence - Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSQoL)

Secondary Outcome Measures

Name	Time	Method
Functional outcomes: micturition: change from baseline (=preoperative value)	6m, 1y, 2y, 3y, 4y	Validated questionnaires; * International Consultation of Incontinence - Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSQoL); * Urogenital Distress Inventory short form (UDI-6)
Functional outcomes: erection: change from baseline (=preoperative value)	6m, 1y, 2y, 3y, 4y	Validated questionnaires; \* International Index of Erectile Dysfunction (IIEF)

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium