Clinical trial NCT07006753: Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
Official title: Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Circumferential Female Urethral Diverticulum
Keywords: circumferential female urethral diverticulum
Transvaginal surgery
Recurrence
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Female patients with imaging-confirmed circumferential urethral diverticulum (UD).

Availability of complete medical records. Minimum of 6 months postoperative follow-up.

Exclusion Criteria:

Presence of uterine prolapse. Diagnosis of vaginitis. Presence of vaginal tumors. Abnormal coagulation function.

Primary outcomes:
measure: Global Response Assessment (GRA)
timeFrame: 6 months postoperatively
measure: Recurrence Rate of Urethral Diverticulum Assessed by Clinical Symptoms
timeFrame: 6 months postoperatively
measure: Urinary Continence Status Assessed by Symptom Type and Stress Test
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Complications
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan University West China Hospital Department of Urology
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Deyi Luo, PhD
role: STUDY_CHAIR
References: