Clinical trial NCT04071925: 9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease
Official title: 9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urethral Stricture
Keywords: urethral stricture disease
urethral stricture
urethra
urethroplasty
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Native men, native women, transmen, transwomen and children with urethral stricture disease.

Brief summary: It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.


Eligibility criteria: Inclusion Criteria:

* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
* Patient age ≥ 6 years.
* If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.

Exclusion Criteria:

- Absence of signed written informed consent and thus a patient unwilling to participate.

Primary outcomes:
measure: Failure-free survival
timeFrame: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively
Secondary outcomes:
measure: Change in erectile function
timeFrame: From the date of preoperative questionnaire completion until 24 months postoperatively.
measure: Change in ejaculatory function
timeFrame: From the date of preoperative questionnaire completion until 24 months postoperatively.
measure: Change in urinary function
timeFrame: From the date of preoperative questionnaire completion until 24 months postoperatively.
measure: Change in urinary continence
timeFrame: From the date of preoperative questionnaire completion until 24 months postoperatively.
measure: Change in quality of life
timeFrame: From the date of preoperative questionnaire completion until 24 months postoperatively.
measure: Change in general quality of life
timeFrame: From the date of preoperative questionnaire completion until 24 months postoperatively.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Dept. of Urology, Ghent University Hospital
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Nicolaas Lumen
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Marjan Waterloos
role: STUDY_CHAIR
affiliation: University Hospital, Ghent
name: Wesley Verla
role: STUDY_DIRECTOR
References: