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NCT Number: NCT07006753

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

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.

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Key information

Conditions

Circumferential Female Urethral Diverticulum Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sichuan University West China Hospital Department of Urology

Chengdu, Sichuan, 610041, China

Location contact

De-yi Luo

CONTACT

[email protected]

+8617826704901

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transvaginal Diverticulum Wall Filling and Coverage Technique

Procedure

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.

Primary outcomes

  1. 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:

    • = Markedly worse
    • = Slightly worse
    • = No change
    • = Slightly improved
    • = Markedly improved

  2. 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

  3. 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

  1. Complications

    Time frame: 6 months postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Sihong Shen

CONTACT

[email protected]

+8615757400692

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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