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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Determine changes in sexual function following intervention measured by validated questionnaire
Determine overall pelvic floor symptoms measured by validated questionnaire
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire
+1 moreTrial 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.
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Who is running the clinical trial?
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
13,009 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,260 Previous Clinical Trials
14,820,710 Total Patients Enrolled
7 Trials studying Urinary Incontinence
382 Patients Enrolled for Urinary Incontinence
Jessica Sassani, MDPrincipal InvestigatorAllegheny Health Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced urinary leakage within the last two weeks, 4-8 weeks after giving birth.I had issues like urinary incontinence before getting pregnant.After giving birth through the vagina, whether it was the first time or not, and whether it was a natural birth or assisted with tools.I had twins or more, or gave birth at 34 weeks or earlier.I have had surgery for urinary incontinence or pelvic organ prolapse.I am willing to do special exercises at home or with a therapist.I have chronic pelvic pain, fecal incontinence, or a history of pelvic floor physical therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Pelvic Floor Physical Therapy (PFPT)
- Group 2: Biofeedback device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining in this trial for participants?
"According to information hosted on clinicaltrials.gov, patient recruitment for this specific trial is not currently occurring. The initial posting date was December 1st 2022 and the most recent editing of the page occurred July 14th 2022. However, there are presently 160 other medical trials that require participant enrollment at this time."
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