Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT06411158
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 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06411158
Study Brief:
Protocol Section:
NCT06411158