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| ID | Type | Description | Link |
|---|---|---|---|
| UG1HD069013 | U.S. NIH Grant/Contract | View source | |
| UG1HD054214 | U.S. NIH Grant/Contract | View source | |
| UG1HD041267 | U.S. NIH Grant/Contract | View source | |
| UG1HD054241 | U.S. NIH Grant/Contract | View source | |
| UG1HD110057 | U.S. NIH Grant/Contract | View source | |
| UG1HD069010 | U.S. NIH Grant/Contract | View source | |
| U24HD069031 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Duke University | OTHER |
| Kaiser Permanente | OTHER |
| University of California, San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventionist-guided training | Active Comparator | Interventionist-guided training at baseline (i.e., 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. 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 | Active Comparator | 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 research smartphone app will have weekly queries of whether exercises were 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to 6 months and 12 months postpartum |
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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
Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Rahn, MD | UTSW | Principal Investigator |
| Marie Gantz, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente -- San Diego | Recruiting | San Diego | California | 92110 | United States |
Study data will be made available through DASH
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Plan to submit full study dataset before the end of the award period.
Access is managed by DASH.
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| OTHER |
| University of Chicago | OTHER |
| University of Pennsylvania | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
| RTI International | OTHER |
The primary analyses will use an intention-to-treat (ITT) population to compare change from baseline in ICIQ-SF score at 6 months between treatment groups using a general linear mixed model.
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The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors.
|
| 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. |
|
| 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. | At 6 months and 12 months postpartum |
| 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). | From baseline to 6 months and 12 months postpartum |
| 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). | At 6 months and 12 months postpartum |
| Change in urinary incontinence measure by the ICIQ-SF | 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). | From baseline to 12 months postpartum |
| University of California - San Diego | Recruiting | San Diego | California | 92121 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Recruiting | Durham | North Carolina | 27707 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Recruiting | Providence | Rhode Island | 02903 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D059952 | Pelvic Floor Disorders |
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D012817 | Signs and Symptoms, Digestive |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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