N/A
N=8
Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
Pelvic Floor Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03528928 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Movement of the Bladder — 23.1 pixels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surface electrical stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Elidah, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movement of the Bladder |
23.1 | — |
Summary
Subjects will place a surface electrode on their perineal area after a bladder-filling protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic floor contraction and electrical stimulation active.
Eligibility Criteria
Inclusion Criteria
- Age:18-80y
- Gender: female
Exclusion Criteria
- Moderate-severe stress incontinence*: As determined by self-reported >3 accidents in 24-hr period
- Currently pregnant, may be pregnant (Unsure pre and peri-menopausal women should take a pregnancy test.)
- Active urinary tract infection (UTI)
- Pelvic pain, Painful bladder syndrome, underlying neurologic/neuromuscular disorder that may impact ability to partake in the trial
- implanted cardiac device or untreated cardiac arrhythmia
- Obesity as defined by BMI >= 30 (height, weight recorded)
- Anyone with impaired decision making, drug or alcohol dependence, or potentially suicidal.
- Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent * Stress urinary incontinence: as determined by an answer of "Yes" to a standard question (from King's Health Questionnaire): "Do you lose urine with physical activities such as coughing, sneezing, running?"
Data sourced from ClinicalTrials.gov (NCT03528928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.