Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- questionnaire of lower urinary tract symptoms
研究概览
简要总结
The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
详细描述
In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with stage II-IV apical compartment defect according to the POP-Q classification
排除标准
- •having severe chronic disease that makes the operation dangerous
- •patients under 25 and patients over 75 years old
结局指标
主要结局
questionnaire of lower urinary tract symptoms
时间窗: changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
the questionaire examines these titles by scoring from one to ten points: 1. sudden feeling of ürination 2. sudden feeling of urination with incontinence 3. Frequent urination 4. Difficulty of starting the urination 5. Abnormal discharge of urine 6. nocturia 7. dyspareunia 8. Stress urinary incontinence 9. dysuria 10. constipation
evaluation of sexual function with Women's Sexual Function Index
时间窗: changes at the preoperative day 1 and postoperative day 40 period
Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
时间窗: changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
次要结局
- Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification(changes at 3,6 and 12. month after surgery)
- questionnaire of lower urinary tract symptoms(changes in symptoms for each title at 3,6 and 12. month after surgery)
- evaluation of sexual function with Women's Sexual Function Index(changes at 3,6 and 12. month after surgery)
研究者
Gamze Nur Cimilli Şenocak
assistant professor
Ataturk University