Training for Urinary Leakage Improvement After Pregnancy

Urinary Incontinence Clinical Trial

— TULIP  

Official title:

Training for Urinary Leakage Improvement After Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411158
• Other study ID #: PFDN-32P01
• Secondary ID: UG1HD069013UG1HD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: NICHD Pelvic Floor Disorders Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delivery Complication
• Enuresis
• Urinary Incontinence

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery	Providence	Rhode Island
United States	Kaiser Permanente -- San Diego	San Diego	California
United States	University of California - San Diego	San Diego	California

Sponsors (10)

Lead Sponsor	Collaborator
NICHD Pelvic Floor Disorders Network	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 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	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 ranges from 0 (least severe) to 38 (most severe).	From baseline to 12 months postpartum
Secondary	Change in Patient Global Impression of Improvement (PGI-I) score	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
Secondary	Change in St. Mark's score	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
Secondary	Female Sexual Function Index (FSFI)	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
Secondary	Health Utility Measure: EuroQOL 5D - 5L	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
Secondary	Health Utility Measure: EuroQOL 5D - VAS	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
Secondary	Changes in physical examination findings - POPQ	Assessment of physical exam findings: prolapse (yes or no) with the POP-Q	From baseline to 12 months postpartum
Secondary	Changes in physical examination findings - PFM integrity	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
Secondary	Changes in physical examination findings - PFM strength	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
Secondary	Changes in physical examination findings - PFM Pain	Assessment of physical exam findings: pelvic floor muscle (PFM) pain (no pain, mild pain, moderate pain, severe pain)	From baseline to 12 months postpartum
Secondary	Adherence to interventions	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
Secondary	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 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