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Procedure

Virtual Pelvic Floor Therapy vs. Device for Stress Incontinence

N/A
Recruiting
Research Sponsored by Pelex
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 4 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of a device plus physical therapy vs physical therapy alone for stress urinary incontinence. Participants will complete a questionnaire at the end to measure outcome.

Who is the study for?
This trial is for women over 18 with stress urinary incontinence, confirmed by the ICIQ questionnaire. It's not suitable for those who've had pelvic or lower back surgery, are pregnant, have done regular Kegel exercises or supervised pelvic training, had certain types of childbirth procedures, or have significant pelvic organ prolapse.Check my eligibility
What is being tested?
The study compares a device called Pelex Upp to standard pelvic floor physical therapy in treating stress urinary incontinence. Participants will either use the device alone, combine it with weekly physical therapy visits, or only attend physical therapy sessions and follow a specific muscle training routine.See study design
What are the potential side effects?
While side effects aren't detailed here, typical ones from such interventions might include discomfort during use of the device or soreness from physical therapy exercises.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in stress urinary incontinence symptoms

Trial Design

3Treatment groups
Active Control
Group I: Pelex Upp Device + Pelvic Floor Physical TherapyActive Control2 Interventions
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.
Group II: Pelex Upp DeviceActive Control1 Intervention
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.
Group III: Pelvic Floor Physical TherapyActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

PelexLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants in this research endeavor?

"According to information available on clinicaltrials.gov, this particular trial has concluded its recruitment phase as of October 18th 2023. Originally posted on the 23rd of October that same year, this study is not longer accepting candidates; however 173 other medical studies are actively seeking participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
2024. "Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097234.
All > Urinary Incontinence
~15 spots leftby Jul 2024
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