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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Global Response Assessment (GRA) [Срок оценки: 6 months postoperatively]
• Recurrence Rate of Urethral Diverticulum Assessed by Clinical Symptoms [Срок оценки: 6 months postoperatively]
• Urinary Continence Status Assessed by Symptom Type and Stress Test [Срок оценки: 6 months postoperatively]

Вторичные конечные точки (1)

• Complications [Срок оценки: 6 months postoperatively]

Критерии участия

Критерии включения

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

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sichuan University West China Hospital Department of Urology — Чэнду

Идентификаторы

NCT: NCT07006753 · 2025692

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗