Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Success rate (cure plus improvement)
研究概览
简要总结
The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.
详细描述
Through the use of a prospective registry, the investigators will collect information on patient characteristics, including age (years), weight (kg), length (cm), previous urological surgeries and other surgeries in the pelvic area, radiotherapeutic treatment of the prostate, and other co-morbidities. Also, if applicable, 24h pad test and preoperative urodynamic results, presence of pre-operative urinary tract infections, and results of preoperative cystoscopy will be reported.
The surgical procedure for treatment of male stress urinary incontinence is according to standard practice. For artificial urinary sphincters, the date and time of surgery, surgeon name, time of shaving, presence of skin wounds, type of prosthesis, cuff location, cuff size, pressure regulating balloon, type of preoperative antibiotics, type of associated procedures will be reported. For slings, similar data will be reported, including type of sling and if there was a release of central tendon.
The patients will fill in the International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence (UI) Short Form (ICIQ-UI Questionnaire SF), the EuroQol Group Questionnaire (EQ-5D-5L) for the evaluation of the impact of incontinence on Quality of Life, and the Sexual Complaints Screener for Men (SCS-M), the Dyadic Adjustment Scale Italian version (DAS), the International Index of Erectile Function Questionnaire (IIEF-15) and the Hospital Anxiety and Depression Scale (HADS) questionnaire before the operation, at 12 weeks after surgery and at yearly intervals up to and including year 5. The results of questionnaires will be entered into the database.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling
- •Participant is willing and able to complete the questionnaires and give informed consent for participation in the study
排除标准
- •Participant unable to complete the questionnaires and declining informed consent for participation in the study
结局指标
主要结局
Success rate (cure plus improvement)
时间窗: 5-years after surgery
Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.
次要结局
- Time being revision-free(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Time being continent(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Revision-free rate(5-years after surgery)
- Patient-reported quality of life(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Post-operative specific adverse events(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Post-operative general adverse events(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
研究者
Sacco Emilio
Associate Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS