Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Emily Lukacz, MD

Description

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.

Details

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-designed 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-designed 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).

Keywords

Urinary Incontinence, Delivery Complication, Pelvic Floor Disorders, Physical Therapy, Biofeedback, Anal Incontinence, Enuresis, Interventionist-guided training, Home pelvic floor exercises guided by the leva® device, Education

Eligibility

You can join if…

Open to females ages 18 years and up

  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.

You CAN'T join if...

  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)

Locations

  • University of California - San Diego
    San Diego California 92121 United States
  • Kaiser Permanente -- San Diego
    San Diego California 92110 United States

Lead Scientist at UCSD

  • Emily Lukacz, MD
    Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 117 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
NICHD Pelvic Floor Disorders Network
ID
NCT06411158
Study Type
Interventional
Participants
Expecting 216 study participants
Last Updated