Clinical trial NCT06411158: Training for Urinary Leakage Improvement After Pregnancy
Official title: Training for Urinary Leakage Improvement After Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Delivery Complication
Keywords: Urinary Incontinence
Pelvic Floor Disorders
Physical Therapy
Biofeedback
Anal Incontinence
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Duke University
name: Kaiser Permanente
name: University of California, San Diego
name: University of Chicago
name: University of Pennsylvania
name: University of Texas Southwestern Medical Center
name: Women and Infants Hospital of Rhode Island
name: RTI International
First posted: 2024-05-13
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary analyses will use an intention-to-treat (ITT) population to compare change from baseline in ICIQ-SF score at 6 months between treatment groups using a general linear mixed model.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 6 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 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.

The primary outcome is change in UI as measured by the ICIQ-SF, comparing scores from baseline to 6 months postpartum. The questionnaire will be sent to participants monthly from baseline through 12 months postpartum.

Secondary outcomes include assessments of 1) a broader spectrum of lower urinary tract symptoms, particularly incontinence, bladder pain, and post-micturition symptoms (LURN-SI-10), 2) The Patient Global Impression of Improvement (PGI-I), 3) anal incontinence will be assessment using the St. Mark's questionnaire, 4) Sexual function/dysfunction using the Female Sexual Function Index (FSFI), 5) a Health Utility Measure: EuroQOL 5D (EQ-5D), 6) changes in physical examination findings: POP-Q, PFM integrity, strength, and pain and 7) adherence to Interventionist PFMT (Arm 1) or Home Biofeedback (Arm 2).

Eligibility criteria: 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. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.

Exclusion Criteria:

1. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
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. Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
7. Unwilling or unable to upload and use external smartphone app(s)

Primary outcomes:
measure: Change in urinary incontinence measure by the ICIQ-SF
timeFrame: From baseline to 6 months postpartum
Secondary outcomes:
measure: Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score
timeFrame: From baseline to 12 months postpartum
measure: Change in Patient Global Impression of Improvement (PGI-I) score
timeFrame: From baseline to 12 months postpartum
measure: Change in St. Mark's score
timeFrame: From baseline to 12 months postpartum
measure: Female Sexual Function Index (FSFI)
timeFrame: From 6 months to 12 months postpartum
measure: Health Utility Measure: EuroQOL 5D - 5L
timeFrame: From baseline to 12 months postpartum
measure: Health Utility Measure: EuroQOL 5D - VAS
timeFrame: From baseline to 12 months postpartum
measure: Changes in physical examination findings - POPQ
timeFrame: From baseline to 12 months postpartum
measure: Changes in physical examination findings - PFM integrity
timeFrame: From baseline to 12 months postpartum
measure: Changes in physical examination findings - PFM strength
timeFrame: From baseline to 12 months postpartum
measure: Changes in physical examination findings - PFM Pain
timeFrame: From baseline to 12 months postpartum
measure: Adherence to interventions
timeFrame: From baseline to 12 months postpartum
measure: Change in urinary incontinence measure by the ICIQ-SF
timeFrame: From baseline to 12 months postpartum
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente -- San Diego
state: California
city: San Diego
country: United States
facility: University of California - San Diego
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Durham
country: United States
facility: Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UTSW
name: David Rahn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Marie Gantz, PhD
role: PRINCIPAL_INVESTIGATOR
References: