Training for Urinary Leakage Improvement After Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 13
- 主要终点
- Change in urinary incontinence measure by the ICIQ-SF
研究概览
简要总结
This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment.
TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®).
The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.
详细描述
TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT) sessions with a skilled interventionist. Arm 2 uses a home biofeedback device (leva®).
All groups will have access to basic education on stress urinary incontinence, overactive bladder, pelvic floor muscle function and continence mechanisms.
Arm 1 will consist of interventionist-guided training at baseline (approximately 8 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session (approximately 4 weeks later), and then continued HEP until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
Arm 2 will consist of home pelvic floor exercises guided by the leva® device and its accompanying app/software for gradually increasing strength and duration of pelvic floor contractions. The Arm 2 exercise regimen begins at approximately 8 weeks postpartum and continues until 12 months postpartum. As in Arm 1, the PFDN research smartphone app resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
Arm 3 participants will only be provided basic education materials. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.
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
The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors.
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
- •≥18yo primiparous patient s/p singleton vaginal delivery (>32 weeks), approximately 6wk postpartum
- •At increased risk of sustained pelvic floor disorders, as defined by
- •neonate ≥3.5kg, and/or
- •operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
- •≥2nd-degree perineal laceration
- •Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.
排除标准
- •Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
- •Stillbirth or significant maternal or neonatal illness
- •Non-English or non-Spanish speaking
- •Perineal wound breakdown or cloaca observed on exam
- •Severe pain with assessments of PFM integrity and/or strength/function
- •Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
- •Unwilling or unable to upload and use external smartphone app(s)
研究组 & 干预措施
Interventionist-guided training
Interventionist-guided training at baseline (i.e., approximately 8 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session approximately 4 weeks later, and then continued HEP. Two exercise sets per day are encouraged between baseline and 6 months postpartum (i.e., time of the primary outcome), followed by at least 3 times-per-week exercise sets until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
干预措施: Interventionist-guided training (Other)
Home pelvic floor exercises guided by the leva® device
Home pelvic floor exercises guided by the leva® device and its accompanying app/software for gradually increasing strength and duration of pelvic floor contractions. The PFDN research smartphone app will have weekly queries of whether exercises were completed.
干预措施: Home pelvic floor exercises guided by the leva® device (Device)
Education
Education will be provided on pelvic floor muscle function and continence mechanisms. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.
干预措施: Education (Other)
结局指标
主要结局
Change in urinary incontinence measure by the ICIQ-SF
时间窗: From baseline to 6 months postpartum
The primary outcome is change in urinary incontinence (UI) as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), comparing scores from baseline to 6 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).
Change in urinary incontinence measure by the ICIQ-SF
时间窗: From baseline to 6 months postpartum
The primary outcome is change in urinary incontinence (UI) as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), comparing scores from baseline to 6 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).
次要结局
- Change in urinary incontinence measure by the ICIQ-SF(From baseline to 12 months postpartum)
- Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score(From baseline to 6 months and 12 months postpartum)
- Patient Global Impression of Improvement (PGI-I) score(At 6 months and 12 months postpartum)
- Change in St. Mark's score(From baseline to 6 months and 12 months postpartum)
- Female Sexual Function Index (FSFI) score(At 6 months and 12 months postpartum)
- Change in urinary incontinence measure by the ICIQ-SF(From baseline to 12 months postpartum)