Incontinence
Conditions
Keywords
Incontinence
Brief summary
The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence
Detailed description
120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown.
Interventions
DEVICEPelvital probe
Pelvital probe
DEVICEPlacebo Probe
Placebo Probe
Sponsors
Pelvital USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female gender, 2. Ages 18-75, 3. Clinical diagnosis of stress urinary incontinence, 4. Ability to contract the pelvic floor muscles, 5. Able to document incontinence and voiding in a diary, 6. Provision of written informed consent form, 7. Minimum of 10 grams increase at initial 24-hour pad weight test
Exclusion criteria
1. Diagnosed mixed or urge urinary incontinence, 2. Impaired cognitive function or neurologic conditions 3. Physical limitations that impede the patient's ability to participate (e.g., ability to stand), 4. Acute infections or hematuria, 5. Pregnant or actively trying to conceive, 6. History of pelvic irradiation, 7. Concurrent medications with α-adrenergic antagonists or diuretics 8. Pelvic organ prolapse stage III or IV, 9. Severe urethral sphincter weakness and/or defect, 10. Suspected urethral and/or vesical fistula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in severity of involuntary urine loss | Baseline, 6 weeks | Measured by pad testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incontinence episode frequency | Baseline, 6 weeks | Daily Diary |
| health-related quality of life | Baseline, 6 weeks | Quality of Life questionarie |
Countries
United States
Outcome results
None listed