Non-Inferiority Randomized Clinical Trial Comparing Behavioral Therapy Plus Pharmacotherapy Versus Pelvic Floor Muscle Training Plus Pharmacotherapy in Women With Urgency Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 主要终点
- Change in ICIQ-SF Total Score from Baseline to Week 8
研究概览
简要总结
Urgency urinary incontinence (UUI) is a common condition that significantly affects women's quality of life. Pharmacotherapy is often used as first-line treatment, but its effectiveness can be limited unless combined with non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) is widely recommended; however, access to specialized physiotherapy services is limited in many low-resource settings such as Nicaragua. Behavioral interventions-including bladder training, fluid control, avoidance of bladder irritants, and sleep-hygiene strategies-represent a low-cost alternative, but direct comparative evidence against PFMT is limited.
This randomized, controlled, non-inferiority clinical trial will compare two adjuvant strategies combined with standard anticholinergic pharmacotherapy (oxibutinine):
- Pelvic floor muscle therapy (PFMT), and
- Behavioral interventions (bladder training and lifestyle modification).
Eighty adult women with urgency urinary incontinence or mixed incontinence with urgency-predominance will be randomized 1:1. The intervention period is 8 weeks, with assessments at baseline, week 4, week 8, and an exploratory follow-up at week 12.
The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to week 8. A non-inferiority margin of 3 points will be applied. Secondary outcomes include episodes of urgency/incontinence per 24 h, ICIQ-LUTSqol scores, patient-reported global improvement (PGI-I), adherence, and adverse events.
This study aims to determine whether behavioral interventions are not inferior to PFMT as adjuncts to pharmacotherapy, potentially offering a feasible and more accessible therapeutic alternative for women with UUI in resource-limited healthcare environments.
详细描述
Urgency urinary incontinence (UUI) is highly prevalent among women and is associated with substantial psychosocial, functional, and economic consequences. Although anticholinergic medications are commonly used, their effectiveness is often improved when combined with adjunctive non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) has strong evidence supporting its use; however, its implementation requires trained personnel, scheduled sessions, and specialized infrastructure, which may not be accessible in low-resource settings.
Behavioral interventions-including bladder training, fluid management, avoidance of bladder irritants, dietary modifications, bowel regulation, and sleep-hygiene measures-represent a practical and low-cost alternative. Despite their clinical utility, there is limited evidence from randomized trials directly comparing behavioral interventions to PFMT when used as adjuncts to pharmacotherapy.
This study is a randomized, controlled, non-inferiority trial conducted at a national reference hospital in Nicaragua. The trial will enroll 80 adult women (≥18 years) diagnosed with UUI or mixed urinary incontinence with urgency predominance. Participants will be randomized in a 1:1 ratio to receive either (1) PFMT plus pharmacotherapy or (2) behavioral interventions plus pharmacotherapy. Oxibutinine (5 mg every 12 hours) will be used as the standard pharmacological agent, with mirabegron available as second-line therapy when intolerance occurs.
The intervention period lasts 8 weeks. PFMT includes supervised sessions twice per week plus a structured home-exercise program. Behavioral interventions include individualized bladder-training schedules, fluid-intake monitoring, avoidance of irritants, lifestyle counseling, and sleep-hygiene strategies. Adherence will be monitored at weeks 4 and 8.
The primary outcome is the change in ICIQ-SF score from baseline to week 8, with non-inferiority defined as an upper bound of the 95% confidence interval below 3 points. Secondary outcomes include ICIQ-LUTSqol, episodes of urgency and incontinence (3-day bladder diary), PGI-I, adherence to interventions, and adverse events. Week 12 assessments will explore persistence of clinical benefit.
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)
盲法说明
Outcome assessors and statisticians will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the interventions.
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
- •Women aged ≥18 years.
- •Symptoms of urgency urinary incontinence (UUI) or mixed urinary incontinence with predominance of urgency, with duration ≥3 months.
- •Clinical diagnosis of UUI based on history, physical examination, and a 3-day bladder diary.
- •Predominance of urgency defined as: at least 50% of total recorded episodes in the bladder diary correspond to urgency (with or without leakage).
- •Baseline ICIQ-SF score ≥
- •Ability to attend scheduled visits and comply with assigned intervention.
- •Signed informed consent.
排除标准
- •Pure stress urinary incontinence.
- •Mixed urinary incontinence with predominance of stress defined as: more than 70% of episodes in the 3-day bladder diary are triggered by physical effort.
- •Symptomatic advanced pelvic organ prolapse (POP-Q stage ≥III).
- •Active or recent urinary tract infection (within the last 7 days).
- •Prior use of anticholinergics or β3-agonists that cannot be discontinued for a 14-day washout period.
- •Pregnancy or breastfeeding.
- •Neurological or psychiatric disorders affecting bladder function, record-keeping, or adherence.
- •Cognitive or functional difficulty preventing understanding or completion of study procedures.
研究组 & 干预措施
Pelvic Floor Muscle Therapy + Pharmacotherapy
Supervised pelvic floor muscle training (PFMT) twice weekly for 8 weeks, including slow and fast contractions, posture education, and home exercises. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur.
干预措施: Pelvic Floor Muscle Training (PFMT) (Behavioral)
Pelvic Floor Muscle Therapy + Pharmacotherapy
Supervised pelvic floor muscle training (PFMT) twice weekly for 8 weeks, including slow and fast contractions, posture education, and home exercises. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur.
干预措施: Oxybutynin / Mirabegron (Standardized Pharmacotherapy) (Drug)
Behavioral Therapy + Pharmacotherapy
Behavioral intervention consisting of bladder training, fluid management, reduction of bladder irritants, sleep hygiene, and healthy lifestyle counseling. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur.
干预措施: Behavioral Bladder Training Program (Behavioral)
Behavioral Therapy + Pharmacotherapy
Behavioral intervention consisting of bladder training, fluid management, reduction of bladder irritants, sleep hygiene, and healthy lifestyle counseling. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur.
干预措施: Oxybutynin / Mirabegron (Standardized Pharmacotherapy) (Drug)
结局指标
主要结局
Change in ICIQ-SF Total Score from Baseline to Week 8
时间窗: Baseline and Week 8
This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score between baseline and week 8. The ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating greater severity.
次要结局
- Change in ICIQ-LUTSqol Score from Baseline to Week 8(Baseline and Week 8)
- Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours(Baseline and Week 8)
- Patient Global Impression of Improvement (PGI-I) at Week 8(Week 8)
- Change in Number of Micturitions per 24 Hours(Baseline and Week 8)
- Change in Number of Urgency Episodes per 24 Hours(Baseline and Week 8)
- Change in Number of Absorbent Pads Used per 24 Hours(Baseline and Week 8)
- Adherence to Assigned Intervention(Throughout the 8-week intervention period)
研究者
Emilio José Dávila Álvarez
Sponsor-Investigator / Principal Investigator
Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"