NCT07006753

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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. Have regular follow-up visits to assess symptoms, complications, and quality of life. Complete questionnaires about urinary and sexual function.

Detailed description

Circumferential UD is a rare and complex subtype that surrounds the urethra and is associated with a higher risk of surgical complications when treated with conventional diverticulectomy. To address these challenges, this study utilizes a modified surgical approach in which the demucosalized diverticular wall is preserved, folded, and used to obliterate the diverticular cavity and reinforce the closure of the ostium. This technique aims to reduce surgical trauma, preserve urethral function, minimize dead space, and improve postoperative urinary and sexual function. All enrolled patients will undergo this standardized surgical intervention. Follow-up assessments will be conducted at predefined timepoints (1 month and 6 months postoperatively). Evaluations will include physical examinations, symptom assessments, and validated questionnaires addressing urinary symptoms, sexual function, and overall quality of life. Primary and secondary outcome measures include: Improvement or resolution of UD-related symptoms (e.g., dysuria, dyspareunia, urgency) Incidence of postoperative complications (e.g., urethrovaginal fistula, de novo stress urinary incontinence) Clinical and imaging-confirmed recurrence Patient-reported outcomes regarding urinary and sexual function This study aims to provide clinical evidence on the feasibility, safety, and potential advantages of this novel technique for managing circumferential urethral diverticulum in women.

Conditions

• Circumferential Female Urethral Diverticulum

Interventions

Type	Name	Description
PROCEDURE	Transvaginal Diverticulum Wall Filling and Coverage Technique	This surgical intervention is a modified transvaginal technique for the treatment of circumferential female urethral diverticulum (UD). Instead of performing a complete diverticulectomy, the procedure utilizes the patient's own demucosalized diverticular wall to fill the diverticular cavity and reinforce closure of the ostium. The technique aims to preserve the integrity of the dorsal urethra, reduce the risk of fistula, minimize dead space, and improve functional outcomes such as continence and sexual function. This approach is specifically designed for circumferential UD, which poses unique anatomical and surgical challenges.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-06-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: China