Recruiting

Pelvic Floor Training

Sponsor:

University of South Florida

Code:

NCT06609317

Conditions

Postpartum Pelvic Floor Function and Symptoms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital therapeutic motion-based device

Study Details

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.

Conditions

Postpartum Pelvic Floor Function and Symptoms

Study ID

NCT06609317

Start date

Apr 4, 2025

Status verified date

Jul, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Device Arm

Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training

Interventions

Digital therapeutic motion-based device

This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training

Primary outcome measure

  • Feasibility [ Time Frame: From enrollment to 6 months postpartum ]
  • Perineal Pain [ Time Frame: From enrollment to 6 months postpartum ]

Central Contacts and Locations

Central contacts

Katie Propst, MD

813-259-0655katiepropst@usf.edu

Maha Al Jumaily, MBBS

813-259-8680mahaaljumaily@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Maha Al Jumaily, MBBS

813-259-8680mahaaljumaily@usf.edu

Principal Investigator:

Katie Propst, MD

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Lisa Hickman, MD

614-293-4643PEARLstudy@osumc.edu

Principal Investigator:

Lisa Hickman, MD

More Information

Sponsor

University of South Florida

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

  • postpartum pelvic muscle training
  • postpartum pelvic floor
  • postpartum pelvic floor physical therapy
  • postpartum urinary incontinence
  • postpartum bowel incontinence
  • postpartum pelvic floor recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-07-29.