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NCT Number: NCT06411158

Training for Urinary Leakage Improvement After Pregnancy

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.

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Key information

Conditions

Urinary Incontinence Behavior Behavioral Symptoms Delivery Complication Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Signs and Symptoms Signs and Symptoms, Digestive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente -- San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interventionist-guided training

Other

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 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

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 completed.

Education

Other

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 outcomes

  1. Change in urinary incontinence measure by the ICIQ-SF

    Time frame: From baseline to 6 months postpartum

    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).

Secondary outcomes

  1. 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

    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).

  2. Patient Global Impression of Improvement (PGI-I) score

    Time frame: At 6 months and 12 months postpartum

    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.

  3. Change in St. Mark's score

    Time frame: From baseline to 6 months and 12 months postpartum

    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).

  4. Female Sexual Function Index (FSFI) score

    Time frame: At 6 months and 12 months postpartum

    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).

  5. Change in urinary incontinence measure by the ICIQ-SF

    Time frame: From baseline to 12 months postpartum

    The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) 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).

Sponsors and collaborators

Lead sponsor

NICHD Pelvic Floor Disorders Network

Network

Collaborators

  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kaiser Permanente
  • RTI International
  • University of California, San Diego
  • University of Chicago
  • University of Pennsylvania
  • University of Texas Southwestern Medical Center
  • Women and Infants Hospital of Rhode Island

Registry information

Acronym: TULIP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 13, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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