Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum

StatusEnrolling by Invitation
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 1, 2026 → Mar 1, 2027
See other at-risk trials from West China Hospital

Record History

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  1. Notable Primary and study completion pushed from Mar 1, 2026 to Mar 1, 2027 Show 8 more changesShow less
    • Phase changed: Phase 2 → not applicable
    • Enrolling by invitation only
    • Enrollment increased: 30 → 100 participants
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Start date changed from estimate of Jun 1, 2025 to Jun 1, 2023
    • Study description expanded, about 6 words
    • Site contact updated
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The goal of this clinical study is to learn if a new surgical technique called transvaginal diverticular wall filling and covering is effective and safe for treating circumferential urethral diverticulum (UD) in female patients. The main questions it aims to answer are: Does this technique reduce the risk of postoperative complications, such as fistula formation or stress urinary incontinence (SUI)? Does it improve urinary symptoms and sexual function? What are the recurrence rates after surgery using this approach? Researchers will follow two groups of patients: One group includes patients who had this surgery in the past 5 years (retrospective group). The other group includes patients who are newly treated with this technique and followed prospectively. Participants will: Undergo the transvaginal wall filling and covering surgery or conventional surgery. Have regular follow-up visits to assess symptoms, complications, and quality of life. Complete questionnaires about urinary and sexual function.
Trial Details
NCT Number NCT07006753
Lead Sponsor West China Hospital
Conditions
(from sponsor)
Circumferential Female Urethral Diverticulum
Related terms Recurrence
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov