Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Long-term Continence Status
研究概览
简要总结
It is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of residual incontinence. Performing subsequent surgeries after the initial VVF repair risks additional complications. Therefore, placement of an autologous sling at the time of initial VVF repair would not only assist in covering the fistula, but would also imitate the physiologic support that would theoretically improve urethral function. A rectus fascia sling would most naturally provide this support and warrants testing against the success of the PC sling.
Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the urethra. Therefore, this group of patients is the target population for this study. As there is currently no standard of care for repairing large urethral defects, this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with vesico-vaginal fistulas classified as Goh 3 or 4 at the time of surgery
- •Patients who have consented for an autologous sling
- •Patients who have not previously undergone repair attempt
排除标准
- •Patients who require an abdominal approach to the VVF repair
- •Patients found at surgery not to have a Goh 3 or 4 class VVF
- •Patients requiring a complete urethral reconstruction
- •Patients who have undergone previous attempt at repair
- •Patients who require an alternative tissue grafting other than the rectus fascia or pubbococcygeus decided by the surgeon at the time of surgery
研究组 & 干预措施
Pubococcygeus Sling
This is one anti-incontinence technique commonly used at the time of fistula surgery.
干预措施: Pubococcygeus sling (Procedure)
Rectus Fascia Sling
This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.
干预措施: Rectus fascia sling (Procedure)
结局指标
主要结局
Long-term Continence Status
时间窗: Six months after surgery
Residual stress incontinence is commonly experienced by this patient population, therefore a dye test to ensure the fistula is still closed and a cough test to determine any incontinence will be performed.
次要结局
- Vesico-vaginal fistula repaired(One month after surgery)
研究者
Jeffrey Wilkinson
Professor of Obstetrics and Gynecology
Baylor College of Medicine