Training for Urinary Leakage Improvement After Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNICHD Pelvic Floor Disorders Network
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Interventionist-guided training
Other interventionInterventionist-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
DeviceHome 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 interventionEducation 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 groups
216 Participants
are divided into 3 treatment groupsGroup A: Interventionist-guided trainingActive comparator 1 intervention
Group B: Home pelvic floor exercises guided by the leva® deviceActive comparator 1 intervention
Group C: EducationOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in urinary incontinence measure by the ICIQ-SF
The primary outcome is change in urinary incontinence (UI) as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), comparing scores from baseline to 6 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).
Time frame
From baseline to 6 months postpartumSecondary outcomes
1
Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score
Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) is designed to address a broader spectrum of lower urinary tract symptoms, particularly incontinence, bladder pain, and post-micturition symptoms. The LURN-SI-10 score ranges from 0 (least severe) to 38 (most severe).
Time frame
From baseline to 6 months and 12 months postpartum2
Patient Global Impression of Improvement (PGI-I) score
Patient Global Impression of Improvement (PGI-I) captures a participant's perceived improvement from baseline, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse.
Time frame
At 6 months and 12 months postpartum3
Change in St. Mark's score
The St. Mark's questionnaire is used to assess anal incontinence symptom severity. St. Mark's Score, ranges from 0 (perfect fecal continence) to 24 (total fecal incontinence).
Time frame
From baseline to 6 months and 12 months postpartum4
Female Sexual Function Index (FSFI) score
Sexual function will be assessed using the Female Sexual Function Index (FSFI), which uses 19 questions to measure 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Female Sexual Function Index scores range from 2.0 (lowest sexual function) to 36.0 (high sexual function).
Time frame
At 6 months and 12 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
NICHD Pelvic Floor Disorders Network
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Duke University
Collaborator
Kaiser Permanente
Collaborator
University of California, San Diego
Collaborator
University of Chicago
Collaborator
University of Pennsylvania
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
RTI International
Collaborator
Source ClinicalTrials.gov