Urethral Stricture Database

NCT06362083 | Recruiting

• 1 other identifier: 34-317 ex 21/22
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.

Conditions

Urethral Stricture

Keywords

Reconstructive surgery; Quality of life; Perioperative Outcomes

Outcome Measures

Primary Outcomes (1)

• Success rate of urethral reconstructive surgeries

  Success is defined as a lack of stricture recurrence in the follow-up

  Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

Secondary Outcomes (3)

• Complications of urethral reconstructive surgeries

  Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

• Sexual function after urethral reconstructive surgeries

  Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

• Health status after urethral reconstructive surgeries

  Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

Interventions

Questionnaires and data collection OTHER

It is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing urethral surgeries or interventions. All patients meeting the inclusion and exclusion criteria of the study should be informed about the possibility of participating in the study.

You may qualify if:

• All patients undergoing any of the following urethral surgeries are included:
• Internal urethrotomy according to Sachse (endoscopic transurethral urethrotomy)
• End-to-end anastomosis
• Urethral plastic surgeries with oral mucosa graft (potentially penile skin)
• Urethral plastic surgeries with mesh graft
• Hypospadias corrections
• Boutonniere
• (Self) bougienage of the urethra

You may not qualify if:

• Lack of capacity to consent

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Röthl Martina Anna

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Interventions

Surveys and Questionnaires; Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 15, 2034
• Study Completion (Estimated): March 15, 2034
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)