Training for Urinary Leakage Improvement After Pregnancy (TULIP)

NICHD Pelvic Floor Disorders Network

Status: Enrolling

Conditions: Urinary Incontinence; Delivery Complication

Treatments: Other: Education; Device: Home pelvic floor exercises guided by the leva® device; Other: Interventionist-guided training

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT06411158

UG1HD054241 (U.S. NIH Grant/Contract)

PFDN-32P01

U24HD069031 (U.S. NIH Grant/Contract)

UG1HD069010 (U.S. NIH Grant/Contract)

UG1HD069013 (U.S. NIH Grant/Contract)

UG1HD054214 (U.S. NIH Grant/Contract)

UG1HD041267 (U.S. NIH Grant/Contract)

UG1HD110057 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 216 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

216 participants in 3 patient groups

Interventionist-guided training

Active Comparator group

Description:

Interventionist-guided training at baseline, followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session, and then continued HEP. Home exercises will be encouraged/ augmented using a PFDN research smartphone app.

Treatment:

Other: Interventionist-guided training

Home pelvic floor exercises guided by the leva® device

Active Comparator group

Description:

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.

Treatment:

Device: Home pelvic floor exercises guided by the leva® device

Education

Other group

Description:

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.

Treatment:

Other: Education