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FGBMM + Pelvic Floor Therapy for Stress Incontinence (SUI Trial)
N/A
Waitlist Available
Led By Anna M Lasak, MD
Research Sponsored by Montefiore Medical Center
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 six months
Awards & highlights
SUI Trial Summary
This trial is investigating whether FGBMM, a type of exercise that is done using shoes that are calibrated to cause pelvic and spine muscles to contract without the patient realizing, can help improve the symptoms of stress urinary incontinence.
Who is the study for?
This trial is for English or Spanish-speaking women aged 18-75 with stress urinary incontinence who can walk at least 50 meters and are under 350 lbs. They should be able to participate in daily walking rehabilitation but haven't had pelvic floor therapy in the past six months, no recent surgery for incontinence, not currently pregnant, and without major cardiovascular issues or active COPD.Check my eligibility
What is being tested?
The study tests if special shoes (FGBMM) that manipulate how you walk can help symptoms of urinary incontinence when used with traditional pelvic floor therapy. The idea is these shoes might make your pelvis and lower trunk muscles work together better without needing complex exercises.See study design
What are the potential side effects?
Since this intervention involves physical activity through specialized footwear and exercise, potential side effects may include muscle soreness, fatigue, or discomfort from the new walking pattern. However, specific side effects related to the footwear have not been detailed.
SUI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Severity of Stress Urinary Incontinence
Secondary outcome measures
6 minute walk test
Adherence to treatment
Gait assessment
+4 moreSUI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FGBMM plus Traditional pelvic floor therapyExperimental Treatment1 Intervention
Treatment with FGBMM using shoes with pertupods daily at home along with traditional pelvic floor therapy sessions.
Group II: Traditional Pelvic Floor TherapyActive Control1 Intervention
up to six sessions, with one session every alternate week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy
2017
N/A
~60
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,141 Total Patients Enrolled
Apos Medical and Sports Technology Ltd.Industry Sponsor
6 Previous Clinical Trials
627 Total Patients Enrolled
Anna M Lasak, MDPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need help from a device to walk during the analysis.You weigh less than 350 pounds.You have received pelvic floor therapy in the last 6 months.You can walk at least 50 meters and have a positive score on the STEADI test.You have had surgery for incontinence before.You have a history of bone fractures caused by osteoporosis.Mainly experiencing urge incontinence.You have had more than 3 falls in the past year, or you have had a fall that caused an injury due to balance issues in the past year.You have serious heart problems that prevent you from participating in an exercise program.You have had a heart-related issue or a COPD flare-up within the past 24 weeks.You are currently being treated for another type of cancer.You have a walking pattern caused by a neurological condition.You experience stress or mixed urinary incontinence, as determined by the UDI-6 questionnaire.Women aged 18 to 75 years old.You can walk every day and take part in a rehabilitation program.
Research Study Groups:
This trial has the following groups:- Group 1: FGBMM plus Traditional pelvic floor therapy
- Group 2: Traditional Pelvic Floor Therapy
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.
What criteria must a participant meet to qualify for this experiment?
"Criteria for inclusion in this study requires that applicants must possess pelvic floor disorders and be aged between 18 to 75. Currently, the total number of participants being recruited is 64 individuals."
Answered by AI
Is the research team still enrolling participants for this experiment?
"According to clinicaltrials.gov, this trial is searching for enrolment in its present iteration - the original listing was made on November 29th 2017 and has been amended as recently as August 19th 2022."
Answered by AI
Does this experiment permit participants of more than twenty years of age?
"This research project is open to adults that are older than 18 and younger than 75."
Answered by AI
How many individuals are currently being recruited for this clinical trial?
"Affirmative, the information hosted on clinicaltrials.gov reflects that this medical trial has been open since November 29th 2017 and is actively recruiting for a total of 64 patients from one center. The record was most recently updated in August 19th 2022."
Answered by AI
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