Digital Therapeutic Device for Pelvic Floor Dysfunction

(PEARL Trial)

Recruiting at 1 trial location

Overseen By Maha Al Jumaily, MBBS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Operative delivery, Cesarean, Episiotomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital therapeutic motion-based device designed to help new mothers strengthen pelvic floor muscles after childbirth. Researchers aim to determine if this device can improve bladder and bowel function, ease symptoms of pelvic organ prolapse (when pelvic organs shift out of place), and reduce vaginal and perineal pain. The trial will also assess its impact on sexual function a few months after delivery. It suits women who had a vaginal delivery 4-8 weeks ago, can walk independently, and have a smartphone. Participants will use the device and complete online surveys over several months. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could benefit new mothers worldwide.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this digital therapeutic device is safe for postpartum pelvic floor muscle training?

Research has shown that the motion-based device for pelvic floor muscle training is generally easy to use. Studies have found that the FDA has approved this device, indicating it meets specific safety standards for use in other conditions.

Users of similar devices for pelvic floor training have reported very few side effects. Most experience only mild discomfort, which typically improves with continued use. The studies available report no major safety concerns.

Overall, the device appears safe for postpartum women seeking to improve pelvic floor function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital therapeutic motion-based device for pelvic floor dysfunction because it offers a new, non-invasive way to strengthen pelvic floor muscles postpartum. Unlike traditional treatments like physical therapy or Kegel exercises, this device uses motion-based technology to guide and enhance muscle training, which could improve user engagement and effectiveness. This innovative approach not only makes the therapy more accessible and convenient at home but also potentially increases adherence and outcomes for new mothers struggling with pelvic floor issues.

What evidence suggests that this digital therapeutic device is effective for pelvic floor dysfunction?

This trial will evaluate a digital therapeutic motion-based device for postpartum pelvic floor muscle training. Research has shown that digital devices can help new mothers strengthen their pelvic floor muscles after childbirth. Studies have found that using these devices can improve bladder control and other related issues. One study discovered that a motion-based device used at home significantly improved symptoms. Another review suggested that digital methods might work faster and better than traditional ones. Overall, these devices seem promising in helping new mothers manage pelvic floor problems effectively. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for women who have had a spontaneous vaginal delivery within the last 4-8 weeks, can walk on their own, agree to participate, speak English, and own a smartphone. It's not specified who cannot join.

Inclusion Criteria

I gave birth naturally between 4 to 8 weeks ago.

I am willing and able to give my consent to participate.

I speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a digital therapeutic motion-based device for postpartum pelvic floor muscle training

6 months

Electronic surveys at baseline, 3 months, and 6 months postpartum

Follow-up

Participants are monitored for bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Digital therapeutic motion-based device

Trial Overview The study tests an FDA-cleared digital device that guides pelvic floor muscle training after childbirth. Participants will use it and report on bladder/bowel function, prolapse symptoms, pain, and sexual function at different postpartum stages.

How Is the Trial Designed?

Group I: Device Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357376/

Digital Technologies for Women's Pelvic Floor Muscle ... ... postpartum pelvic floor muscle training: pilot ... based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748920300122

Effect of app-based audio guidance pelvic floor muscle ... Wu et al. Pelvic floor muscle training versus watchful waiting and pelvic floor disorders in postpartum women: a systematic review and meta-analysis ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/13/4/e069874

Efficacy of supervised pelvic floor muscle training with a ... ... effective in improving UI in pregnant and postpartum women.15 19 20 ... Managing female pelvic floor disorders: a medical device review and appraisal.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12036775/

Impact of a Digital Therapeutic Device on Pelvic Floor ... Moreover, the use of an at-home motion-based biofeedback device may further improve concomitant symptoms. Pelvic floor disorders (PFDs), ...

5. advances.massgeneral.org advances.massgeneral.org/urology/journal.aspx?id=2234

Pelvic Floor Muscle Training Device Provides Faster, Better ... Fecal Incontinence Linked to High Prevalence of Urinary Incontinence in Women with Pelvic Floor Disorders. Marcus V. Ortega, MD, and Milena M.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06609317?lead=tampa%20general%20hospital%20OR%20University%20of%20South%20Florida&sort=StudyFirstPostDate&viewType=Table&keyword=cancer%252520institute&rank=7

Study Details | NCT06609317 | Postpartum pElvic Assisted ... The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10151990/

Efficacy of supervised pelvic floor muscle training with a ... Efficacy of supervised pelvic floor muscle training with a home-based biofeedback device for urinary incontinence in postpartum women: protocol ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421001427

Randomized trial comparing efficacy of pelvic floor muscle ... Intravaginal motion based digital therapeutic device for pelvic floor muscle training. ... pelvic floor dysfunction. Int. Urogynecol. J. (2020). C. Wu et al ...

9. mhealth.jmir.org mhealth.jmir.org/2023/1/e44929

Digital Technologies for Women's Pelvic Floor Muscle ... Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction.