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Functional Outcome of Urethral Reconstructive Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01982136
Enrollment
175
Registered
2013-11-13
Start date
2009-08-31
Completion date
2019-10-31
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethral Stricture

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.

Interventions

PROCEDUREend-to-end urethroplasty
PROCEDUREsubstitution urethroplasty (buccal mucosa)
PROCEDUREsubstitution urethroplasty (pedicled skin flap)

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* male * urethral stricture surgery * informed consent

Exclusion criteria

* loss of follow-up * not willing to participate

Design outcomes

Primary

MeasureTime frameDescription
Quality Of Life: change from baseline (=preoperative value)6m, 1y, 2y, 3y, 4yValidated 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

MeasureTime frameDescription
Functional outcomes: micturition: change from baseline (=preoperative value)6m, 1y, 2y, 3y, 4yValidated 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, 4yValidated questionnaires \* International Index of Erectile Dysfunction (IIEF)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026