Urinary Incontinence Clinical Trial
— TULIPOfficial title:
Training for Urinary Leakage Improvement After Pregnancy
Verified date | May 2024 |
Source | NICHD Pelvic Floor Disorders Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 216 |
Est. completion date | June 1, 2027 |
Est. primary completion date | June 1, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. =18yo primiparous patient s/p singleton vaginal delivery (>32 weeks), approximately 6wk postpartum 2. At increased risk of sustained pelvic floor disorders, as defined by 1. neonate =4kg, and/or 2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or 3. 3rd or 4th-degree perineal laceration 3. With symptomatic, bothersome UI as defined by a score of =6 on the ICIQ-SF. Exclusion Criteria: 1. Inability to follow in-person or home PFMT instructions; and 2. Stillbirth or significant maternal or neonatal illness 3. Non-English or non-Spanish speaking 4. Perineal wound breakdown or cloaca observed on exam 5. Severe pain with assessments of PFM integrity and/or strength/function 6. Unwilling or unable to upload and use external smartphone app(s) |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Durham | North Carolina |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Providence | Rhode Island |
United States | Kaiser Permanente -- San Diego | San Diego | California |
United States | University of California - San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
NICHD Pelvic Floor Disorders Network | Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kaiser Permanente, RTI International, University of California, San Diego, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in urinary incontinence measure by the ICIQ-SF | 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, for a range of scores from 0 (no leakage or bother) to 21 (worst leakage, most bothersome). A fourth question asks which type(s) of leakage are occurring. | From baseline to 6 months postpartum | |
Secondary | Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score | Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) is designed to address a broader spectrum of lower urinary tract symptoms, particularly incontinence, bladder pain, and post-micturition symptoms. The LURN-SI-10 ranges from 0 (least severe) to 38 (most severe). | From baseline to 12 months postpartum | |
Secondary | Change in Patient Global Impression of Improvement (PGI-I) score | Patient Global Impression of Improvement (PGI-I) is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. | From baseline to 12 months postpartum | |
Secondary | Change in St. Mark's score | The St. Mark's is used to assess anal incontinence. St. Mark's Score, ranges from 0 (least severe) to 24 (most severe). | From baseline to 12 months postpartum | |
Secondary | Female Sexual Function Index (FSFI) | Sexual function/dysfunction will be assessed using the Female Sexual Function Index (FSFI), which uses 19 questions to measure 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Female Sexual Function Index, ranges from 0 (least severe) to 36 (most severe). | From 6 months to 12 months postpartum | |
Secondary | Health Utility Measure: EuroQOL 5D - 5L | European Quality of Life-5 Dimensions (EQ-5D) is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EQ-5D-5L has 5 attributes (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems |
From baseline to 12 months postpartum | |
Secondary | Health Utility Measure: EuroQOL 5D - VAS | The European Quality of Life-5 Dimensions (EQ-5D-5L) includes the EQ VAS scale with a range 100 (the best health you can imagine) to 0 (the worst health you can imagine). | From baseline to 12 months postpartum | |
Secondary | Changes in physical examination findings - POPQ | Assessment of physical exam findings: prolapse (yes or no) with the POP-Q | From baseline to 12 months postpartum | |
Secondary | Changes in physical examination findings - PFM integrity | Assessment of physical exam findings: pelvic floor muscle (PFM) integrity (present, absent, or equivocal on left and right sides) | From baseline to 12 months postpartum | |
Secondary | Changes in physical examination findings - PFM strength | Assessment of physical exam findings: pelvic floor muscle (PFM) strength using Modified Oxford Scale. The Modified Oxford Scale has 5 grades, which are as follows:
Grade 0: No contraction felt Grade 1: Contraction felt but minimal lift Grade 2: Contraction felt with a moderate lift Grade 3: Contraction felt with a good lift Grade 4: Strong contraction felt with a very good lift |
From baseline to 12 months postpartum | |
Secondary | Changes in physical examination findings - PFM Pain | Assessment of physical exam findings: pelvic floor muscle (PFM) pain (no pain, mild pain, moderate pain, severe pain) | From baseline to 12 months postpartum | |
Secondary | Adherence to interventions | Assessment of adherence to the two active interventions (Arm 1 Interventionist PFMT and Arm 2 the Home Feedback) will be assessed with a Visual Analog Score from 0%-100%. | From baseline to 12 months postpartum | |
Secondary | Change in urinary incontinence measure by the ICIQ-SF | 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 12 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage, for a range of scores from 0 (no leakage or bother) to 21 (worst leakage, most bothersome). A fourth question asks which type(s) of leakage are occurring. | From baseline to 12 months postpartum |
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