Urethral Stricture Database

Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Urethral Stricture
• Intervention / Treatment: Other: Questionnaires and data collection

Detailed Description

The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture. In addition to pre-operative basic data, intraoperative and postoperative data, as well as follow-up data through questionnaires, are to be collected. The main objective is the prospective determination of success rates of the performed urethral surgeries in the short, medium, and long term. Furthermore, risk factors leading to failure (recurrence of urethral stricture) should be identified. Ultimately, the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures.

In today's reconstructive urethral surgery, there are few scientific surveys so far. Many of the applied techniques (therapy options) are based more on the experiences of individual surgeons than on a solid database, hence there are also different approaches. By evaluating prospective data and comparing individually applied surgical methods, the least complication-prone and most successful techniques are to be identified. The planned study aims to create an "efficacy-safety" profile for each urethral surgery technique. This will enable us in the future to not only provide improved (data-based) patient information but also to involve the patient better in the therapy decision. Thus, in the future, counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active, even with the same stricture length and location.

The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Röthl Martina Anna
      • Contact: Marianne Leitsmann, Prof. Dr.; Phone Number: +43 316 385 80550; Email: martina.roethl@medunigraz.at
      • Principal Investigator: Marianne Leitsmann, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Lack of capacity to consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of urethral reconstructive surgeries	Complications are defined as surgical site infection, fistula, problems at the preservation site of buccal mucosa.	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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): January 15, 2034
• Study Completion (Estimated): March 15, 2034

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Perioperative Outcomes; Reconstructive surgery
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: 34-317 ex 21/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No