Training for Urinary Leakage Improvement After Pregnancy
Training for Urinary Leakage Improvement After Pregnancy
Recruiting
N/AInterventional Study
Urinary IncontinenceDelivery Complication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
216 (estimated)
Sponsor
NICHD Pelvic Floor Disorders Network · Research network
Who this trial is looking for
This trial is looking for women who have given birth and are experiencing problems with urinary leakage. If you qualify, you will participate in training to help improve pelvic floor muscle strength.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18 or older
I have given birth to my first child vaginally more than 6 weeks ago
I have urinary leakage that bothers me
My baby weighed more than 3.5 kg at birth or I had an operative delivery or a second-degree laceration
You may not be able to join if
I cannot attend follow-up appointments after 6 months
I have had a stillbirth or serious illness related to childbirth
I cannot speak English or Spanish
I have problems with my perineal wound
I have severe pain during pelvic floor muscle assessments
I am currently receiving physical therapy for my pelvic floor
I am not willing to use smartphone apps required for the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 cons…
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.
Trial Locations
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Eligibility Criteria
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 ≥3.5kg, and/or
2. operative delivery (i.e., forceps or vacuum-assisted vaginal deliver…
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 ≥3.5kg, and/or
2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
3. ≥2nd-degree perineal laceration
3. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.
Exclusion Criteria:
1. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
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. Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
7. Unwilling or unable to upload and use external smartphone app(s)
Contacts
No contact information available.
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