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Pelvital Stress Urinary Incontinence Training Device: P-SUIT

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ClinicalTrials.gov Identifier: NCT02954042
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Incontinence Device: Pelvital probe Device: Placebo Probe Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pelvital Stress Urinary Incontinence Training Device: P-SUIT
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pelvital probe
Probe to use for incontinence-Pevital is company name of product
Device: Pelvital probe
Pelvital probe

Placebo Comparator: Placebo Probe
Placebo probe
Device: Placebo Probe
Placebo Probe




Primary Outcome Measures :
  1. Improvement in severity of involuntary urine loss [ Time Frame: Baseline, 6 weeks ]
    Measured by pad testing


Secondary Outcome Measures :
  1. incontinence episode frequency [ Time Frame: Baseline, 6 weeks ]
    Daily Diary

  2. health-related quality of life [ Time Frame: Baseline, 6 weeks ]
    Quality of Life questionarie



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954042


Contacts
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Contact: Bethany Marlette 612-626-6661 marle025@umn.edu

Locations
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United States, Minnesota
University of Minnesota Medical Center Recruiting
Maple Grove, Minnesota, United States, 55369
Contact: Rosanne Ferguson    763-898-1714    fergu296@umn.edu   
Principal Investigator: Nissrine Nakib, MD         
Metro OBGYN Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Emy Harrington    651-265-6770    eharrington@metro-obgyn.com   
Principal Investigator: Kevin Hallman, MD         
Sub-Investigator: Rjangvald Mjanger, MD         
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Bethany Marlette    612-626-6661    marle025@umn.edu   
Principal Investigator: Nissrine Nakib, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Reba Blissell    206-616-8723    blissr@uw.edu   
Principal Investigator: Suzette Sutherland, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Nissrine Nakib, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02954042     History of Changes
Other Study ID Numbers: Pelvital
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Incontinence

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders