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Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Primary Purpose

Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvital probe
Placebo Probe
Sponsored by
Pelvital USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence focused on measuring Incontinence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Medical Center
  • Metro OBGYN
  • University of Minnesota Medical Center
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pelvital probe

Placebo Probe

Arm Description

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

Placebo probe

Outcomes

Primary Outcome Measures

Improvement in severity of involuntary urine loss
Measured by pad testing

Secondary Outcome Measures

incontinence episode frequency
Daily Diary
health-related quality of life
Quality of Life questionarie

Full Information

First Posted
October 28, 2016
Last Updated
April 13, 2021
Sponsor
Pelvital USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02954042
Brief Title
Pelvital Stress Urinary Incontinence Training Device: P-SUIT
Official Title
Pelvital Stress Urinary Incontinence Training Device: P-SUIT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pelvital USA, Inc.

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence
Keywords
Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvital probe
Arm Type
Experimental
Arm Description
Probe to use for incontinence-Pevital is company name of product
Arm Title
Placebo Probe
Arm Type
Placebo Comparator
Arm Description
Placebo probe
Intervention Type
Device
Intervention Name(s)
Pelvital probe
Intervention Description
Pelvital probe
Intervention Type
Device
Intervention Name(s)
Placebo Probe
Intervention Description
Placebo Probe
Primary Outcome Measure Information:
Title
Improvement in severity of involuntary urine loss
Description
Measured by pad testing
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
incontinence episode frequency
Description
Daily Diary
Time Frame
Baseline, 6 weeks
Title
health-related quality of life
Description
Quality of Life questionarie
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nissrine Nakib, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Metro OBGYN
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pelvital Stress Urinary Incontinence Training Device: P-SUIT

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