Functional Outcome of Urethral Reconstructive Surgery

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

Detailed Description
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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.

Official Title
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Prospective Long-term Single Center Cohort Study Assessing Functional Outcome of Urethral Reconstructive Surgery

Conditions
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Urethral Stricture

Intervention / Treatment
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* Procedure: end-to-end urethroplasty
* Procedure: substitution urethroplasty (buccal mucosa)
* Procedure: substitution urethroplasty (pedicled skin flap)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male urethral stricture surgery informed consent Exclusion Criteria: loss of follow-up not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urethral stricture<br>patients requiring surgery for urethral stricture | Procedure: end-to-end urethroplasty<br> <br> Procedure: substitution urethroplasty (buccal mucosa)<br> <br> Procedure: substitution urethroplasty (pedicled skin flap)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Of Life: change from baseline (=preoperative value) | 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) | 6m, 1y, 2y, 3y, 4y | 

Secondary Outcome Measures

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