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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: Recruiting NA study of Postpartum Pelvic Floor Function and Symptoms, sponsored by University of South Florida.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Feasibility will be assessed using participant reported discomfort with device use, ease of device use, net promotor score, patient satisfaction, and free text feedback on the device.
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 |
What NCT06609317 shows while recruiting
NCT06609317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06609317's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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