Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess sexual function
研究概览
简要总结
Urinary incontinence (UI) is a common and disabling condition that affects millions of people worldwide and significantly impacts the quality of life of those affected. It is well established that urinary incontinence negatively affects sexual life. Although there is no definitive consensus yet, many authors report that sexual function, after surgical intervention to restore continence, is likely to improve or, at the very least, remain unchanged.
详细描述
The primary objective of the study is to evaluate sexual function in women 6 months after implantation of an artificial urinary sphincter.
Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.
The patients concerned are women who have undergone implantation of an artificial urinary sphincter.
Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 80 years
- •Patients with from urinary incontinence with an appropriate surgical indication for artificial urinary sphincter implantation
- •Patients who accept the surgical indication and have signed the informed consent for the procedure
- •No objection from the patients to participate in the study after reading the information sheet
排除标准
- •- Pregnant or breastfeeding patients
- •Life expectancy of less than 2 years
- •Patients who have undergone colpocleisis surgery
- •Patients with neurological conditions causing loss of sensation
- •Patients reporting no interest in sexual activity
- •Patients suffering from chronic pelvic pain
结局指标
主要结局
Assess sexual function
时间窗: 6 months
sexual quality of life assessed at 6 months post operatively by the PISQ-12 questionnaire (scale from 0 to 48).
次要结局
- Assess sexual function(12 months)
- Assess sexual quality of life(6 and 12 months)
- Assess urinary incontinence (clinical efficacy)(6 and 12 months)
- Assess quality of life(6 and 12 months)
- Assess complications(6 and 12 months)