Functional Outcome of Urethral Reconstructive Surgery

N/ACompletedNCT01982136

Universitaire Ziekenhuizen KU Leuven175 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

175

Conditions

Urethral Stricture

Interventions

end-to-end urethroplastyPROCEDURE

substitution urethroplasty (buccal mucosa)PROCEDURE

substitution urethroplasty (pedicled skin flap)PROCEDURE

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

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)

Time frame: 6m, 1y, 2y, 3y, 4y

Secondary Outcomes

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)

Time frame: 6m, 1y, 2y, 3y, 4y

Functional outcomes: erection: change from baseline (=preoperative value)

Validated questionnaires \* International Index of Erectile Dysfunction (IIEF)

Time frame: 6m, 1y, 2y, 3y, 4y

Data from ClinicalTrials.gov

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