This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.
Who can participate
Age range21 Years – 75 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Predominant Mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more.
Exclusion Criteria:
* Severe incontinence as determined by self-reported \>5 accidents in 24-hr period
* Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
* Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
* Cancer, epilepsy or cognitive dysfunction
* Vaginal or pelvic surgery within previous 6 months
* Complete denervation of the pelvic floor
* History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
* Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year)
* Recurrent vaginitis (bacterial/fungal)
* Pelvic pain/painful bladder syndrome
* Underlying neurologic/neuromuscular disorder
* Severe Obesity as defined by BMI \>= 35
* Chronic coughing
* Impaired decision making, drug or alcohol dependence, or suicidal thoughts.
* Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.
What they're measuring
1
Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes