Comparison of Standard Pelvic Floor Strengthening Exercise with a Novel Therapeutic Exercise Machine for Non-Surgical Management of Urinary Incontinence
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-009315
Sponsor Protocol Number: 15-009315
About this study
Compare baseline scores on urinary incontinence questionnaires to 2 month scores (within and between treatment groups), compare patient satisfaction scores at 2 months (between group comparison), and compare baseline EMG to 2 month EMG scores (within and between group comparison)
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Women 21-70 years of age
- Bothersome stress urinary incontinence (bother ≥ 4/10 in a ten point bother scale)
- Stress predominant mixed urinary incontinence (bother due to SUI ≥ 50%)
Exclusion Criteria:
- Advanced pelvic organ prolapse (stage 3 or greater)
- previous urinary incontinence surgery
- Nnon-English speakers
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Emanuel Trabuco, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available