Recruiting

Virtual Pelvic Floor & Trainer

Sponsor:

Pelex

Code:

NCT06097234

Conditions

Stress Urinary Incontinence

Pelvic Floor Disorders

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelex Upp

Pelvic Floor Physical Therapy

Study Details

Brief summary:

The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical therapy.

The main questions it aims to answer are:

Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy?

Does treatment with the device under study combined with pelvic floor physical therapy improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy alone and treatment with the device alone?

Participants will be given one of three treatments:

1. The devices under study alone
2. The device under study plus 4 weekly visits with a pelvic floor physical therapist
3. Four weekly visits with a physical therapist alone Participants will perform a standardized pelvic floor muscle training program 10 minutes a day, four times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Conditions

Stress Urinary Incontinence

Pelvic Floor Disorders

Study ID

NCT06097234

Start date

Jan 1, 2024

Status verified date

Mar, 2024

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Female

  • 18 years of age or older
  • Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

Exclusion Criteria:

  • History of pelvic or lower back surgery
  • Pregnancy
  • History of physician-supervised pelvic floor muscle training
  • History of Kegel exercises greater than once a month
  • History of prior operative delivery
  • Self-reported history of pelvic organ prolapse stage II or greater

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pelex Upp Device

Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.

active comparator: Pelex Upp Device + Pelvic Floor Physical Therapy

Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.

In addition, subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide further care instructions and pelvic floor training.

active comparator: Pelvic Floor Physical Therapy

Subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide care instructions and pelvic floor training, as well as provide a weekly treatment schedule for Kegel exercises.

Interventions

Pelex Upp

Biofeedback-mediated pelvic floor trainer. It captures contraction and relaxation of the pelvic floor muscles during use by the subject, and represents these contractions and relaxations back to the subject to improve conscious control of the muscle groups.

Pelvic Floor Physical Therapy

A form of physical therapy whereby the subject is given instructions on how to identify the pelvic floor, how to coordinate the pelvic floor contractions and relaxations, as well as counseling on dietary changes that affect pelvic floor and pelvic organ function

Primary outcome measure

  • Change in stress urinary incontinence symptoms [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Pelex

Recruiting

Little Neck, New York, United States, 11363

Contacts

More Information

Sponsor

Pelex

Last update posted

Mar 29, 2024

Last verified

Mar, 2024

Keywords

  • pelvic floor
  • urinary incontinence
  • incontinence
  • pelvic floor training
  • biofeedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pelex on 2024-03-29.