Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- West China Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Global Response Assessment (GRA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Transvaginal Diverticulum Wall Filling and Coverage Technique
Transvaginal Diverticulum Wall Filling and Coverage Technique for Circumferential UD
Intervention: Transvaginal Diverticulum Wall Filling and Coverage Technique (Procedure)
Outcomes
Primary Outcomes
Global Response Assessment (GRA)
Time Frame: 6 months postoperatively
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
Recurrence Rate of Urethral Diverticulum Assessed by Clinical Symptoms
Time Frame: 6 months postoperatively
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
Urinary Continence Status Assessed by Symptom Type and Stress Test
Time Frame: 6 months postoperatively
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
Secondary Outcomes
- Complications(6 months postoperatively)
Investigators
De-yi Luo
Prof
West China Hospital