Optimizing Treatment Outcomes for Women With Stress Urinary Incontinence Through the Identification of Factors Contributing to Successful Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 7
- 主要终点
- Change in pad weight on a standardized 30 minute pad test
研究概览
简要总结
Urinary incontinence (UI) affects up to 50% of adult populations and stress urinary incontinence (SUI) is the most common form of UI, accounting for approximately 60% of patients. Women are affected by SUI much more often than men. Urine leakage in women with SUI occurs on exertion or during tasks that increase pressure on the bladder such as sneezing or coughing. SUI has been shown to be a barrier to physical activity in women, and as such can contribute to the development of diseases and disorders associated with inactivity.
SUI appears to have many contributing factors such as structural damage (eg. tears in the pelvic organ supporting tissues), muscle weakness related to nerve injury or aging, or thinning of the urethral wall and/or its surrounding muscular sphincters. Currently the most common treatments for SUI are conservative therapy, which normally takes the form of exercise therapy provided by specialized nurses or physical therapists, and surgery, which is aimed at enhancing urethral support. Exercise therapy is effective, resulting in complete cure in 50% of cases, and surgery is effective for approximately 80% of patients but carries risks such as the development of urinary retention. It is currently not clear which treatment approach is better for which women.
Through the proposed research, the investigators aim to determine how to predict which patients will improve or be cured with exercise therapy such that surgery can be avoided. Specifically the investigators will determine what is different between patients in whom exercise therapy succeeds and in whom exercise therapy fails. The investigators will also determine whether physiotherapist-supervised training of the pelvic floor muscles before surgery improves surgical outcomes. The proposed research will enable us to better understand the female continence system and how it responds to physiotherapeutic intervention. It will help us to develop improved assessment procedures that can streamline patient management.
详细描述
It is hypothesized that participants in the physical therapy group will demonstrate greater improvements in pelvic floor muscle (PFM) function after treatment when compared to the control group. It is also expected that women in the physical therapy group will show better post-surgical outcomes when compared to the control group. The investigators will also develop and test a predictive model to identify those women with SUI who will benefit from physical therapy.
Objective 1: to evaluate characteristics predictive of the success or failure of PFM training in women with SUI.
To meet this objective, a cohort study will be used. Women with SUI will be recruited prospectively, will provide demographic information, will undergo a clinical evaluation of their PFM strength, will fill out the International Consultation on Incontinence Questionnaires (ICIQs), and will undergo an extensive evaluation of their continence system using ultrasound imaging. Ultrasound imaging will be used to measure muscle morphology (the presence and extent of PFM defect, PFM cross sectional area, urethral sphincter cross sectional area), fascial support (position of the bladder neck at rest and on Valsalva maneuver) and urethral mobility (amount of excursion of the urethra on coughing). A predictive multivariate binary logistic regression model will be developed to determine whether demographic variables, PFM strength, PFM morphology measures, fascial support or urethral mobility measured prior to the intervention can predict which women with SUI are cured after a standardized 12-week physical therapy program aimed at improving the strength, power, endurance and motor control of the PFMs.
Objective 2: to determine whether a program of pre- and peri-operative physical therapy aimed at improving the strength and motor control of the PFMs improves surgical outcomes relative to usual care in women with predominant symptoms of SUI.
Women who are waiting for surgery to treat symptoms of SUI at two hospital sites will be randomized to either a physical therapy group or a control group. Women assigned to the physical therapy group will receive a standardized 12 week program of PFM training prior to their surgery, will continue with these exercises until they undergo surgery, and will resume their exercises after surgery. The control group will receive usual care, which is a handout describing PFM exercises. The primary outcome of this study will be reported scores on patient-oriented ICIQs, which will be completed on entering the study, twelve weeks later, and at surgical follow up visit 12 weeks after surgery. Analysis of variance models will be used to compare outcomes between the physiotherapy group and the control group both before surgery and at 12 weeks after surgery. Chi Square models will assess whether cure rates are higher in women belonging to the physical therapy as compared to the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •minimum age of 18
- •primary diagnosis of stress urinary incontinence by urogynaecologist
- •on the surgical wait list for surgery to address stress urinary incontinence
排除标准
- •currently pregnant or <6 months post-partum
- •pelvic mass (es)
- •pad test weight gain less than 1g at baseline testing
- •no episode of SUI as demonstrated by a 3-day bladder diary
- •having received more than 4 sessions of physical therapy in the past 5 years specifically for treating their symptoms of SUI
- •detrusor instability as identified by routine urodynamics studies performed as part of the patient evaluation by the urogynaecologist
- •prolapse (> POP-Q stage 2)
- •are taking medications known to increase or alleviate incontinence
- •not willing to cease other treatment for SUI treatment during the course of study
- •fecal incontinence (e.g., pessary)
- •prior urogynecological surgery to address urinary incontinence
- •neurological impairments involving the central nervous system or the sacral nerves or known connective tissue disorders
- •major psychiatric conditions which impact significantly with daily functioning and would prevent full participation in the study
- •physical impairment that would prevent the participant from completing the 20-minute pad test (a major study outcome measure)
- •in situ devices that would not be suitable for ultrasound testing
研究组 & 干预措施
Control
Participants in the control group will not receive therapist-supervised intervention. An exercise sheet briefly describing pelvic floor muscle exercises will be provided, as would be the standard practice from most physicians.
Pelvic Floor Therapy
Participants in the experimental group undergo and assessment and treatment by a registered physiotherapist. Treatments will include two sessions of biofeedback training, therapist-assisted strengthening exercises, and will a prescribed home exercise program to strengthen their pelvic floor muscles.
干预措施: Pelvic Floor muscle strengthening exercises (Other)
结局指标
主要结局
Change in pad weight on a standardized 30 minute pad test
时间窗: 12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery
Change in pad weight (in g) on a standardized pad test will be compared between the treatment and control groups
Change in International Consultation on Incontinence Questionnaire: Female Lower Urinary Tract Symptoms (FLUTS)
时间窗: 12 weeks before surgrey (TVT or TVT-O) to 12 weeks after surgery
Changes in ICIQ FLUTS scores will be compared between treatment and control groups
Change in International Consultation on Incontinence Questionnaire - Short form score
时间窗: 12 weeks before surgery (TVT or TVT-O) to 12 weeks after surgery
Changes in questionnaire scores will be compared between treatment and control groups
次要结局
- Change in International Consultation on Incontinence Questionnaire Quality of Life module score(12 weeks before surgery (TVT, TVT-O) to 12 weeks after surgery)
研究者
Dr. Linda McLean
Associate Professor
Queen's University