Functional Outcome of Urethral Reconstructive Surgery

October 28, 2019 updated by: Universitaire Ziekenhuizen KU Leuven

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent urethral reconstruction in our center from 2009 to this date

Description

Inclusion Criteria:

  • male
  • urethral stricture surgery
  • informed consent

Exclusion Criteria:

  • loss of follow-up
  • not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcomes: micturition: change from baseline (=preoperative value)
Time Frame: 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)
6m, 1y, 2y, 3y, 4y
Functional outcomes: erection: change from baseline (=preoperative value)
Time Frame: 6m, 1y, 2y, 3y, 4y

Validated questionnaires

* International Index of Erectile Dysfunction (IIEF)
6m, 1y, 2y, 3y, 4y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Frank Van der Aa, MD-PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML9859
  • S55868 (Other Identifier: UZLeuven)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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