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).
