Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Global Response Assessment (GRA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with imaging-confirmed circumferential urethral diverticulum (UD).
- •Availability of complete medical records. Minimum of 6 months postoperative follow-up.
排除标准
- •Presence of uterine prolapse. Diagnosis of vaginitis. Presence of vaginal tumors. Abnormal coagulation function.
研究组 & 干预措施
Transvaginal Diverticulum Wall Filling and Coverage Technique
Transvaginal Diverticulum Wall Filling and Coverage Technique for Circumferential UD
干预措施: Transvaginal Diverticulum Wall Filling and Coverage Technique (Procedure)
结局指标
主要结局
Global Response Assessment (GRA)
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Complications(6 months postoperatively)