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Completed

NCT Number: NCT01982136

Functional Outcome of Urethral Reconstructive Surgery

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

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Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UZ Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male
  • urethral stricture surgery
  • informed consent

Exclusion criteria

  • loss of follow-up
  • not willing to participate

Treatment and study plan

end-to-end urethroplasty

Procedure

substitution urethroplasty (buccal mucosa)

Procedure

substitution urethroplasty (pedicled skin flap)

Procedure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

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

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

    Validated questionnaires

    • International Index of Erectile Dysfunction (IIEF)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2013
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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