Training for Urinary Leakage Improvement After Pregnancy

Overview

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 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.

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, and change through 12 months postpartum is a secondary outcome.

Interventions

• Other Interventionist-guided training
  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 smartphon
• Device 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. 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
• 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 measures

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

Secondary outcome measures (5)

• Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score [Time frame: From baseline to 6 months and 12 months postpartum]
• Patient Global Impression of Improvement (PGI-I) score [Time frame: At 6 months and 12 months postpartum]
• Change in St. Mark's score [Time frame: From baseline to 6 months and 12 months postpartum]
• Female Sexual Function Index (FSFI) score [Time frame: At 6 months and 12 months postpartum]
• Change in urinary incontinence measure by the ICIQ-SF [Time frame: From baseline to 12 months postpartum]

Eligibility criteria

Inclusion criteria

• ≥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.

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 7 centers

• Kaiser Permanente -- San Diego — San Diego
• University of California - San Diego — San Diego
• University of Chicago — Chicago
• Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham
• University of Pennsylvania — Philadelphia
• Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and — Providence
• University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT06411158 · PFDN-32P01 · UG1HD069013 · UG1HD054214 · UG1HD041267 · UG1HD054241 · UG1HD110057 · UG1HD069010 · U24HD069031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗