Functional Outcome of Urethral Reconstructive Surgery
Study Details
Study Description
Brief Summary
The analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Urethral stricture patients requiring surgery for urethral stricture |
Procedure: end-to-end urethroplasty
Procedure: substitution urethroplasty (buccal mucosa)
Procedure: substitution urethroplasty (pedicled skin flap)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
male
-
urethral stricture surgery
-
informed consent
Exclusion Criteria:
-
loss of follow-up
-
not willing to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Belgium |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Frank Van der Aa, MD-PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML9859
- S55868