An interventional study of Transvaginal Diverticulum Wall Filling and Coverage Technique and Conventional surgery in Circumferential Female Urethral Diverticulum, sponsored by West China Hospital. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by West China Hospital · Not applicable, Interventional, and Treatment
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.
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 the transvaginal wall filling and covering surgery or conventional surgery. 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.
West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
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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.
Transvaginal Diverticulum Wall Filling and Coverage Technique for Circumferential UD
Procedure: Transvaginal Diverticulum Wall Filling and Coverage Technique
Treat with conventional surgery
Procedure: Conventional surgery
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.
Treat with conventional surgery
Global Response Assessment (GRA)
Overall subjective improvement will also be documented using a 5-point Global Response Assessment (GRA) scale: 1. = Markedly worse 2. = Slightly worse 3. = No change 4. = Slightly improved 5. = Markedly improved
Time frame: 6 months postoperatively
Recurrence Rate of Urethral Diverticulum Assessed by Clinical Symptoms
Recurrence will be assessed within 6 months postoperatively based on: Return of typical urethral diverticulum (UD) symptoms, such as: Post-void dribbling Dyspareunia Dysuria Recurrent urinary tract infections Palpable anterior vaginal wall mass
Time frame: 6 months postoperatively
Urinary Continence Status Assessed by Symptom Type and Stress Test
Urinary continence status will be evaluated at 6 months postoperatively based on: Patient-reported urinary symptoms, including the presence or absence of: Stress urinary incontinence (SUI): involuntary leakage of urine during physical effort, sneezing, or coughing Urgency urinary incontinence (UUI): involuntary leakage accompanied by or immediately preceded by urgency Objective cough stress test performed in the lithotomy position with a comfortably full bladder Patients will be classified into one of the following categories: Continent: No symptoms of SUI or UUI and negative stress test SUI: Symptomatic stress incontinence or positive stress test UUI: Symptoms consistent with urgency-related leakage Mixed urinary incontinence: Presence of both SUI and UUI symptoms
Time frame: 6 months postoperatively
Complications
Time frame: 6 months postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Mar 2027, 45 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Jun 2025 → Jun 2023, primary completion Mar 2026 → Mar 2027 and completion Mar 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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