Urinary IncontinenceTULIPNCT06411158
Training for Urinary Leakage Improvement After Pregnancy
A study testing Interventionist-guided training, Home pelvic floor exercises guided by the leva® device and Education in people with Urinary Incontinence and Delivery Complication, run by NICHD Pelvic Floor Disorders Network at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Delivery Complication
- What is being tested?
- Interventionist-guided training, Home pelvic floor exercises guided by the leva® device and Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Nov 2024to 12 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jinxuan (Rowena) Shi, 872-724-0774, jinxuan.shi@bsd.uchicago.edu
Kimberly Kenton, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Agnes Burris, (214) 645-3833, Agnes.Burris@UTSouthwestern.edu
David Rahn, MD
- Recruiting
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
Stephanie Yu, (919) 401-1016, stephanie.yu@duke.edu
Nazema Siddiqui, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Zandra Kennedy, (215) 615-6569, zandra.kennedy@pennmedicine.upenn.edu
Heidi Harvie, MD
- Recruiting
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903
Julia Shinnick, MD, (401) 453-7560, jshinnick@wihri.org
Vivian Sung, MD
- Recruiting
Kaiser Permanente -- San Diego
San Diego, California, 92110
Gisselle Zazueta-Damian, 619-821-5717, gisselle.zazueta-damian@kp.org
Linda Mackinnon, 619-821-6009, linda.m.mackinnon@kp.org
- Recruiting
University of California - San Diego
San Diego, California, 92121
Kyle Herrala, 858-657-6827, UrogynRSCH@ucsd.edu
Emily Lukacz, MD
About this study
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.
Read the 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 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.
- Conditions
- Urinary Incontinence, Delivery Complication
- Being tested
- Interventionist-guided training, Home pelvic floor exercises guided by the leva® device, Education
- Keywords
- Urinary Incontinence, Pelvic Floor Disorders, Physical Therapy, Biofeedback, Anal Incontinence
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventionist-guided trainingOther
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® deviceDevice
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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interventionist-guided training |
| 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. Receives: Device: Home pelvic floor exercises guided by the leva® device |
| 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. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 6 months postpartum
Secondary outcomes (5)
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).
Measured: From baseline to 6 months and 12 months postpartum
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline to 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start12 Nov 2024
- Primary completion12 May 2027 (estimated)
- Study completion12 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University, Kaiser Permanente, University of California, San Diego, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island, RTI International
- Responsible party
- Sponsor
- Investigators
- David Rahn, MD, Principal investigator, UTSWMarie Gantz, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411158
- Sponsor's protocol ID
- PFDN-32P01
- Other IDs
- UG1HD069013, UG1HD054214, UG1HD041267, UG1HD054241, UG1HD110057, UG1HD069010, U24HD069031
- Acronym
- TULIP
- Status last verified
- Dec 2025
- First submitted
- 3 May 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study data will be made available through DASH
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training for Urinary Leakage Improvement After Pregnancy
- ClinicalTrials.gov ID
- NCT06411158
- Acronym / sponsor ID
- TULIP / PFDN-32P01
- Conditions
- Urinary Incontinence, Delivery Complication
- Keywords
- Urinary Incontinence, Pelvic Floor Disorders, Physical Therapy, Biofeedback, Anal Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University, Kaiser Permanente, University of California, San Diego, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island, RTI International
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 12 Nov 2027 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventionist-guided training | Active comparator | Other: Interventionist-guided trainingInterventionist-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 | Device: Home pelvic floor exercises guided by the leva® deviceHome 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 | Other: EducationEducation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventionist-guided trainingInterventionist-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. | Other | Interventionist-guided training |
| Home pelvic floor exercises guided by the leva® 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. | Device | Home pelvic floor exercises guided by the leva® device |
| EducationEducation 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 |
Primary outcome
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).
5 secondary outcomes
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
Patient Global Impression of Improvement (PGI-I) score
Time frame: At 6 months and 12 months postpartum
Change in St. Mark's score
Time frame: From baseline to 6 months and 12 months postpartum
Female Sexual Function Index (FSFI) score
Time frame: At 6 months and 12 months postpartum
Change in urinary incontinence measure by the ICIQ-SF
Time frame: From baseline to 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. Study data will be made available through DASH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Rahn, MD principal investigator
UTSW
Marie Gantz, PhD principal investigator
RTI International
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventionist-guided training, Home pelvic floor exercises guided by the leva® device and Education in people with Urinary Incontinence and Delivery Complication, run by NICHD Pelvic Floor Disorders Network at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary incontinence measure by the ICIQ-SF (time frame: From baseline to 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.