Training for Urinary Leakage Improvement After Pregnancy

Part of paid clinical trials in San Diego, California.

Sponsor
NICHD Pelvic Floor Disorders Network
Study ID
NCT06411158
Status
Recruiting
Apply to this trial

Conditions

  • Delivery Complication
  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interventionist-guided training — OTHER
    Interventionist-guided training at baseline (i.e., 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. 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.
  • Home pelvic floor exercises guided by the leva® device — 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. Between baseline and 6 months postpartum, twice-daily exercise sets will be encouraged, followed by at least 3 times-per-week exercises from 6 to 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.
  • Education — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Dec 2025
Primary completion
May 12, 2027
Completion
Nov 12, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Other: 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.

Primary Outcome Measure

Change in urinary incontinence measure by the ICIQ-SF [ Time Frame: From baseline to 6 months postpartum ]

Locations (7)

FacilityCityStateZIPSite coordinators
Kaiser Permanente -- San DiegoSan DiegoCalifornia92110
Gisselle Zazueta-Damian
[email protected]
619-821-5717
Linda Mackinnon
[email protected]
619-821-6009
Shawn A Menefee, MD (PRINCIPAL_INVESTIGATOR)
University of California - San DiegoSan DiegoCalifornia92121
Kyle Herrala
[email protected]
858-657-6827
Emily Lukacz, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Jinxuan (Rowena) Shi
[email protected]
872-724-0774
Kimberly Kenton, MD (PRINCIPAL_INVESTIGATOR)
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic SurgeryDurhamNorth Carolina27707
Stephanie Yu
[email protected]
(919) 401-1016
Nazema Siddiqui, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Zandra Kennedy
[email protected]
(215) 615-6569
Heidi Harvie, MD (PRINCIPAL_INVESTIGATOR)
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive SurgeryProvidenceRhode Island02903
Julia Shinnick, MD
[email protected]
(401) 453-7560
Vivian Sung, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Agnes Burris
[email protected]
(214) 645-3833
David Rahn, MD (PRINCIPAL_INVESTIGATOR)

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