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Behavioural Intervention

Home Biofeedback vs Pelvic Floor Therapy for Urinary Incontinence

N/A
Recruiting
Led By Jessica Sassani, MD
Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Multiple births or deliver at ≤34 weeks
Previous urinary incontinence or pelvic organ prolapse surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two different treatments for pelvic floor dysfunction in postpartum women.

Who is the study for?
This trial is for postpartum women who have given birth vaginally (first-time or multiple births) and are experiencing urinary incontinence. They must be willing to do PFPT or home biofeedback exercises, own a smartphone with Bluetooth, and have noticed urine leakage between 4-8 weeks after giving birth. Women with multiple births, preterm delivery at ≤34 weeks, prior surgeries for incontinence or pelvic organ prolapse, or known pelvic floor disorders before pregnancy cannot participate.
What is being tested?
The study is testing if using a home biofeedback device called Pericoach® can improve life quality related to urinary incontinence as effectively as Pelvic Floor Physical Therapy (PFPT). Postpartum women will be randomly assigned to either the device use at home or therapy sessions.
What are the potential side effects?
There may not be significant side effects from participating; however, some discomfort during physical therapy exercises could occur. The Pericoach® device should also be safe but might cause minor irritation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had twins or more, or gave birth at 34 weeks or earlier.
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I have had surgery for urinary incontinence or pelvic organ prolapse.
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I have chronic pelvic pain, fecal incontinence, or a history of pelvic floor physical therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
Secondary study objectives
Determine changes in sexual function following intervention measured by validated questionnaire
Determine overall pelvic floor symptoms measured by validated questionnaire
Determine the patient impression of symptom improvement using validated questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Pelvic Floor Physical Therapy (PFPT)Active Control1 Intervention
6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.
Group II: Biofeedback deviceActive Control1 Intervention
Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
48 Previous Clinical Trials
12,942 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,327 Previous Clinical Trials
14,874,740 Total Patients Enrolled
7 Trials studying Urinary Incontinence
382 Patients Enrolled for Urinary Incontinence
Jessica Sassani, MDPrincipal InvestigatorAllegheny Health Network

Media Library

Pelvic Floor Physical Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05194462 — N/A
Urinary Incontinence Research Study Groups: Pelvic Floor Physical Therapy (PFPT), Biofeedback device
Urinary Incontinence Clinical Trial 2023: Pelvic Floor Physical Therapy Highlights & Side Effects. Trial Name: NCT05194462 — N/A
Pelvic Floor Physical Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194462 — N/A
~41 spots leftby Jan 2026
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