Postpartum Pelvic Floor Function and SymptomsPEARLNCT06609317
Postpartum pElvic Assisted Recovery With Leva
A study testing Digital therapeutic motion-based device in people with Postpartum Pelvic Floor Function and Symptoms, run by University of South Florida at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Pelvic Floor Function and Symptoms
- What is being tested?
- Digital therapeutic motion-based device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Lisa Hickman, MD, 614-293-4643, PEARLstudy@osumc.edu
Lisa Hickman, MD
- Recruiting
University of South Florida
Tampa, Florida, 33606
Maha Al Jumaily, MBBS, 813-259-8680, mahaaljumaily@usf.edu
Katie Propst, MD
About this study
Official title: Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
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.
- Being tested
- Digital therapeutic motion-based device
- Keywords
- postpartum pelvic muscle training, postpartum pelvic floor, postpartum pelvic floor physical therapy, postpartum urinary incontinence, postpartum bowel incontinence, postpartum pelvic floor recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital therapeutic motion-based deviceDevice
This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training Receives: Device: Digital therapeutic motion-based device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
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.
Measured: From enrollment to 6 months postpartum
Perineal Pain
Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.
Measured: From enrollment to 6 months postpartum
Secondary outcomes (5)
Bladder function
Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum.
Measured: From enrollment to 6 months postpartum
Bowel Function
Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.
Measured: From enrollment to 6 months postpartum
Pelvic Organ Prolapse
Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum.
Measured: From enrollment to 6 months postpartum
Vaginal pain
Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum.
Measured: From enrollment to 6 months postpartum
Sexual function
Participants will complete validated surveys assessing sexual function at 3 months postpartum and 6 months postpartum.
Measured: From enrollment to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start4 Apr 2025
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Pelvic Floor Function and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609317
- Sponsor's protocol ID
- 007382
- Acronym
- PEARL
- Status last verified
- Jul 2025
- First submitted
- 20 Sep 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
- ClinicalTrials.gov ID
- NCT06609317
- Acronym / sponsor ID
- PEARL / 007382
- Keywords
- postpartum pelvic muscle training, postpartum pelvic floor, postpartum pelvic floor physical therapy, postpartum urinary incontinence, postpartum bowel incontinence, postpartum pelvic floor recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: Digital therapeutic motion-based deviceParticipants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Spontaneous vaginal delivery within the last 4-8 weeks
- Age ≥ 18 years
- Ambulatory
- Willing and able to consent to participate.
- English speaking
Key exclusion criteria (5 listed)
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital therapeutic motion-based deviceThis intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training | Device | Device Arm |
Primary outcome
Feasibility
Time frame: From enrollment to 6 months postpartum
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.
Perineal Pain
Time frame: From enrollment to 6 months postpartum
Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.
5 secondary outcomes
Bladder function
Time frame: From enrollment to 6 months postpartum
Bowel Function
Time frame: From enrollment to 6 months postpartum
Pelvic Organ Prolapse
Time frame: From enrollment to 6 months postpartum
Vaginal pain
Time frame: From enrollment to 6 months postpartum
Sexual function
Time frame: From enrollment to 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital therapeutic motion-based device in people with Postpartum Pelvic Floor Function and Symptoms, run by University of South Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Propst, MD (813-259-0655, katiepropst@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From enrollment to 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.