NCT06609317 Postpartum pElvic Assisted Recovery With Leva
| NCT ID | NCT06609317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Postpartum Pelvic Floor Function and Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-04-04 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-04-04 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device. In addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum. Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.
Eligibility Criteria
Inclusion Criteria: * Spontaneous vaginal delivery within the last 4-8 weeks * Age ≥ 18 years * Ambulatory * Willing and able to consent to participate. * English speaking * Owns a smartphone Exclusion Criteria: * Operative or cesarean delivery * Obstetric delivery at less than 20 weeks gestation * Third- or fourth-degree perineal laceration * Episiotomy * Multiples
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06609317 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Pelvic Floor Function and Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06609317 currently recruiting?
Yes, NCT06609317 is actively recruiting participants. Contact the research team at katiepropst@usf.edu for enrollment information.
Where is the NCT06609317 trial being conducted?
This trial is being conducted at Tampa, United States, Columbus, United States.
Who is sponsoring the NCT06609317 clinical trial?
NCT06609317 is sponsored by University of South Florida. The trial plans to enroll 25 participants.