Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh; Retrospective Cohort Study With Prospective Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Long-term anatomical success rate
研究概览
简要总结
This study aims to assess safety and efficacy of transvaginal repair of cystocele using four armed collagen coated polyester mesh beyond 5 years postoperatively.
详细描述
Cystocele, also known as anterior vaginal wall prolapse, is a common condition in females, particularly those with or without uterine prolapse.
Traditionally, cystocele repair has been performed using native tissue suturing techniques. This method involves reinforcing the weakened vaginal wall by plicating and tightening the patient's tissues without introducing any foreign material. While suture repair is associated with fewer foreign body complications, long-term studies have reported notable recurrence rates, leading some surgeons to seek alternative methods.
Mesh insertion involves placing a synthetic material underneath the bladder to reinforce the vaginal wall and improve long-term anatomical outcomes. Although mesh repairs initially showed promising results in reducing recurrence, concerns have arisen regarding complications such as mesh erosion, chronic pelvic pain, and dyspareunia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Data of patients who underwent transvaginal cystocele repair using four-armed collagen coated polyester mesh
排除标准
- •Patients with insufficient postoperative follow-up data.
- •Patients with incomplete or missing medical records.
- •Patients undergone radiation, laser therapy, or chemotherapy in the pelvic area postoperatively.
- •Patients newly discovered uncontrolled diabetes mellitus.
结局指标
主要结局
Long-term anatomical success rate
时间窗: 5 years of follow-up postoperatively
Long-term anatomical success rate is defined as the absence of anterior vaginal wall prolapse or the presence of only Stage 0-I cystocele according to Pelvic Organ Prolapse Quantification (POP-Q) classification after 5 years of follow-up postoperatively.
次要结局
- Functional improvement(5 years of follow-up postoperatively)
- Sexual function(5 years of follow-up postoperatively)
- Long-term complications(5 years of follow-up postoperatively)
- Assesment of quality of life(5 years of follow-up postoperatively)
研究者
Ibrahim Abdelghany
Resident of Urology, Faculty of Medicine, Ain Shams University, Egypt.
Ain Shams University