Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Evaluate the sexual discomfort in the medium term in patients who have undergone surgery for stress urinary incontinence by placing a suburethral sling.
研究概览
简要总结
Evaluation of the sexual quality of life of women who had a sub-urethral sling several years ago, using a recently validated questionnaire: the PPSSQ (Pelvi-Perineal Surgery Sexuality Questionnaire).
This questionnaire is specifically oriented for women who have undergone surgery for stress urinary incontinence or prolapse. It contains questions specific to post-surgical issues that are not present in other sexual quality of life questionnaires. The questionnaire will also be administered to a group of control women who have not had suburethral sling surgery in order to compare their responses to those of women who have had surgery.
The hypothesis is that the placement of a suburethral sling for stress urinary incontinence increases the quality of sexual life of the women.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patient group
- •Women who have received a suburethral sling at CHUGA in the gynecology or urology departments between January 2015 and June
- •Women who agreed to complete the PPSSQ
- •Healthy volunteers group
- •Adult women matched on age and menopausal status to the patient group
- •Women who have never undergone surgery for stress urinary incontinence by placing a sub-urethral tape.
- •Women who agreed to complete the PPSSQ
排除标准
- •Patient group
- •Tape removal.
- •Death since surgery.
- •Factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the French language, illiteracy.
- •Absence of perineal sensation.
- •Persons referred to in articles L1121-5 to L1121-8 of the CSP.
- •Healthy volunteers group
- •Factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the French language, illiteracy.
- •Absence of perineal sensation.
- •Persons referred to in articles L1121-5 to L1121-8 of the CSP.
结局指标
主要结局
Evaluate the sexual discomfort in the medium term in patients who have undergone surgery for stress urinary incontinence by placing a suburethral sling.
时间窗: 2 to 7 years after the surgery
The primary endpoint of the research is the comparison of medians of the PPSSQ "discomfort and pain" score between women who underwent suburethral sling surgery and healthy female volunteers of the same age and menopausal status.
次要结局
- Analyze the causes of discomfort and the characteristics of pain experienced by patients during intercourse.(2 to 7 years after the surgery)
- To analyze the rate of non-sexually active patients after surgery, and the causes of this lack of sexuality.(2 to 7 years after the surgery)
- To evaluate the quality of sexual life of patients who have undergone surgery for stress urinary incontinence using a suburethral sling.(2 to 7 years after the surgery)
- Compare sexual discomfort and quality of sexual life before/after suburethral sling surgery.(2 to 7 years after the surgery)