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NCT06609317 · ClinicalTrials.gov registry record · NA
Postpartum pElvic Assisted Recovery With Leva
A NA study of Postpartum Pelvic Floor Function and Symptoms, sponsored by University of South Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT06609317 is a NA study of Postpartum Pelvic Floor Function and Symptoms that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 25 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT06609317, a NA study of Postpartum Pelvic Floor Function and Symptoms, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Digital therapeutic motion-based device
Study Locations (2)
Florida
- University of South Florida - Tampa
Ohio
- Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-04-04 |
| Est. Completion | 2026-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06609317
The ClinicalTrials.gov registry entry for NCT06609317 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postpartum Pelvic Floor Function and Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Digital therapeutic motion-based device is the first listed.
NCT06609317 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT06609317 about?
NCT06609317 is a clinical study titled "Postpartum pElvic Assisted Recovery With Leva". 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 ...
What is the current status of trial NCT06609317?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2025-04-04. Estimated completion is 2026-02.
What conditions does trial NCT06609317 study?
This clinical trial studies the following conditions: Postpartum Pelvic Floor Function and Symptoms.
What interventions are being tested in trial NCT06609317?
The interventions under investigation include: Digital therapeutic motion-based device (DEVICE).
Who is sponsoring clinical trial NCT06609317?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06609317 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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