NCT01982136

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

10.2 years

First QC Date

October 24, 2013

Last Update Submit

October 28, 2019

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Functional outcomes: micturition: change from baseline (=preoperative value)

    6m, 1y, 2y, 3y, 4y

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

    6m, 1y, 2y, 3y, 4y

Study Arms (1)

Urethral stricture

patients requiring surgery for urethral stricture

Procedure: end-to-end urethroplastyProcedure: substitution urethroplasty (buccal mucosa)Procedure: substitution urethroplasty (pedicled skin flap)

Interventions

end-to-end urethroplastyPROCEDURE
Urethral stricture
substitution urethroplasty (buccal mucosa)PROCEDURE
Urethral stricture
substitution urethroplasty (pedicled skin flap)PROCEDURE
Urethral stricture

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • male
  • urethral stricture surgery
  • informed consent

You may not qualify if:

  • loss of follow-up
  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Frank Van der Aa, MD-PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 13, 2013

Study Start

August 1, 2009

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

BE(1)