Training for Urinary Leakage Improvement After Pregnancy (TULIP)

May 7, 2024 updated by: NICHD Pelvic Floor Disorders Network

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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-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).

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • University of California - San Diego
        • Principal Investigator:
          • Emily Lukacz, MD
        • Contact:
      • San Diego, California, United States, 92110
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
        • Principal Investigator:
          • Kimberly Kenton, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
        • Contact:
        • Principal Investigator:
          • Nazema Siddiqui, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
        • Contact:
        • Principal Investigator:
          • Vivian Sung, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • David Rahn, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. With symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.

Exclusion Criteria:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interventionist-guided training
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-designed smartphone app that will offer reminder notifications to conduct exercises.
Other: Interventionist-guided training
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-designed smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
Active Comparator: Home pelvic floor exercises guided by the leva® 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. The PFDN-designed smartphone app will offer reminder notifications to conduct exercise and weekly queries of whether exercises were completed.
Device: Home pelvic floor exercises guided by the leva® 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-designed smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.
Other: Education
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.
Other: Education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, for a range of scores from 0 (no leakage or bother) to 21 (worst leakage, most bothersome). A fourth question asks which type(s) of leakage are occurring.
From baseline to 6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score
Time Frame: From baseline to 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 ranges from 0 (least severe) to 38 (most severe).
From baseline to 12 months postpartum
Change in Patient Global Impression of Improvement (PGI-I) score
Time Frame: From baseline to 12 months postpartum
Patient Global Impression of Improvement (PGI-I) is used to compare condition improvement, 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.
From baseline to 12 months postpartum
Change in St. Mark's score
Time Frame: From baseline to 12 months postpartum
The St. Mark's is used to assess anal incontinence. St. Mark's Score, ranges from 0 (least severe) to 24 (most severe).
From baseline to 12 months postpartum
Female Sexual Function Index (FSFI)
Time Frame: From 6 months to 12 months postpartum
Sexual function/dysfunction 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, ranges from 0 (least severe) to 36 (most severe).
From 6 months to 12 months postpartum
Health Utility Measure: EuroQOL 5D - 5L
Time Frame: From baseline to 12 months postpartum

European Quality of Life-5 Dimensions (EQ-5D) is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EQ-5D-5L has 5 attributes (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).

EQ-5D descriptive system is divided into five levels of perceived problems:

LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems
From baseline to 12 months postpartum
Health Utility Measure: EuroQOL 5D - VAS
Time Frame: From baseline to 12 months postpartum
The European Quality of Life-5 Dimensions (EQ-5D-5L) includes the EQ VAS scale with a range 100 (the best health you can imagine) to 0 (the worst health you can imagine).
From baseline to 12 months postpartum
Changes in physical examination findings - POPQ
Time Frame: From baseline to 12 months postpartum
Assessment of physical exam findings: prolapse (yes or no) with the POP-Q
From baseline to 12 months postpartum
Changes in physical examination findings - PFM integrity
Time Frame: From baseline to 12 months postpartum
Assessment of physical exam findings: pelvic floor muscle (PFM) integrity (present, absent, or equivocal on left and right sides)
From baseline to 12 months postpartum
Changes in physical examination findings - PFM strength
Time Frame: From baseline to 12 months postpartum

Assessment of physical exam findings: pelvic floor muscle (PFM) strength using Modified Oxford Scale. The Modified Oxford Scale has 5 grades, which are as follows:

Grade 0: No contraction felt Grade 1: Contraction felt but minimal lift Grade 2: Contraction felt with a moderate lift Grade 3: Contraction felt with a good lift Grade 4: Strong contraction felt with a very good lift
From baseline to 12 months postpartum
Changes in physical examination findings - PFM Pain
Time Frame: From baseline to 12 months postpartum
Assessment of physical exam findings: pelvic floor muscle (PFM) pain (no pain, mild pain, moderate pain, severe pain)
From baseline to 12 months postpartum
Adherence to interventions
Time Frame: From baseline to 12 months postpartum
Assessment of adherence to the two active interventions (Arm 1 Interventionist PFMT and Arm 2 the Home Feedback) will be assessed with a Visual Analog Score from 0%-100%.
From baseline to 12 months postpartum
Change in urinary incontinence measure by the ICIQ-SF
Time Frame: From baseline to 12 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 12 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage, for a range of scores from 0 (no leakage or bother) to 21 (worst leakage, most bothersome). A fourth question asks which type(s) of leakage are occurring.
From baseline to 12 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Pelvic Floor Disorders Network

Collaborators

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

Investigators

  • Principal Investigator: Marie Gantz, PhD, RTI International
  • Principal Investigator: David Rahn, MD, UTSW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFDN-32P01
  • UG1HD069013 (U.S. NIH Grant/Contract)
  • UG1HD054214 (U.S. NIH Grant/Contract)
  • UG1HD041267 (U.S. NIH Grant/Contract)
  • UG1HD054241 (U.S. NIH Grant/Contract)
  • UG1HD110057 (U.S. NIH Grant/Contract)
  • UG1HD069010 (U.S. NIH Grant/Contract)
  • U24HD069031 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data will be made available through DASH

IPD Sharing Time Frame

Plan to submit full study dataset before the end of the award period.

IPD Sharing Access Criteria

Access is managed by DASH.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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