Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2019-10-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pelvital probe

Probe to use for incontinence-Pevital is company name of product

Group Type EXPERIMENTAL

Pelvital probe

Intervention Type DEVICE

Pelvital probe

Placebo Probe

Placebo probe

Group Type PLACEBO_COMPARATOR

Placebo Probe

Intervention Type DEVICE

Placebo Probe

Interventions

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Pelvital probe

Intervention Type DEVICE

Placebo Probe

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No