Functional Outcome of Urethral Reconstructive Surgery

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982136
• Other study ID #: ML9859
• Secondary ID: S55868
• Status: Completed
• Start date: August 2009
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male

• urethral stricture surgery

• informed consent

Exclusion Criteria:

• loss of follow-up

• not willing to participate

Related Conditions & MeSH terms

• Urethral Stricture

Intervention

Procedure:
• end-to-end urethroplasty

• substitution urethroplasty (buccal mucosa)

• substitution urethroplasty (pedicled skin flap)

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Functional outcomes: erection: change from baseline (=preoperative value)	Validated questionnaires; * International Index of Erectile Dysfunction (IIEF)	6m, 1y, 2y, 3y, 4y