Pelvital Stress Urinary Incontinence Training Device: P-SUIT
1 other identifier
interventional
120
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedStudy Start
First participant enrolled
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedApril 14, 2021
April 1, 2021
2.6 years
October 28, 2016
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in severity of involuntary urine loss
Measured by pad testing
Baseline, 6 weeks
Secondary Outcomes (2)
incontinence episode frequency
Baseline, 6 weeks
health-related quality of life
Baseline, 6 weeks
Study Arms (2)
Pelvital probe
EXPERIMENTALProbe to use for incontinence-Pevital is company name of product
Placebo Probe
PLACEBO COMPARATORPlacebo probe
Interventions
Eligibility Criteria
You may qualify if:
- Female gender,
- Ages 18-75,
- Clinical diagnosis of stress urinary incontinence,
- Ability to contract the pelvic floor muscles,
- Able to document incontinence and voiding in a diary,
- Provision of written informed consent form,
- Minimum of 10 grams increase at initial 24-hour pad weight test
You may not qualify if:
- Diagnosed mixed or urge urinary incontinence,
- Impaired cognitive function or neurologic conditions
- Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
- Acute infections or hematuria,
- Pregnant or actively trying to conceive,
- History of pelvic irradiation,
- Concurrent medications with α-adrenergic antagonists or diuretics
- Pelvic organ prolapse stage III or IV,
- Severe urethral sphincter weakness and/or defect,
- Suspected urethral and/or vesical fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Minnesota Medical Center
Maple Grove, Minnesota, 55369, United States
Metro OBGYN
Maplewood, Minnesota, 55109, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
Nakib N, Sutherland S, Hallman K, Mianulli M, R Boulware D. Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women. Ther Adv Urol. 2024 Feb 6;16:17562872241228023. doi: 10.1177/17562872241228023. eCollection 2024 Jan-Dec.
PMID: 38328552DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Nissrine Nakib, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 3, 2016
Study Start
March 10, 2017
Primary Completion
October 30, 2019
Study Completion
October 30, 2019
Last Updated
April 14, 2021
Record last verified: 2021-04