Pelvital Stress Urinary Incontinence Training Device: P-SUIT | NCT02954042

Studies
Pelvital Stress Urinary Incontinence Training Device: P-SUIT

NCT02954042

Sponsor

Pelvital USA, Inc.

Status

Completed

Last Update Posted

Apr 14, 2021Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Incontinence

Interventions

Pelvital probe
Placebo Probe

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2017Actual

Primary Completion Date

Oct 30, 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Oct 28, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pelvital probe	Experimental	Probe to use for incontinence-Pevital is company name of product	Device: Pelvital probe
Placebo Probe	Placebo Comparator	Placebo probe	Device: Placebo Probe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pelvital probe	Device	Pelvital probe	Pelvital probe
Placebo Probe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in severity of involuntary urine loss	Measured by pad testing	Baseline, 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
incontinence episode frequency	Daily Diary	Baseline, 6 weeks
health-related quality of life	Quality of Life questionarie	Baseline, 6 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nissrine Nakib, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota Medical Center		Maple Grove	Minnesota	55369	United States
Metro OBGYN

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38328552	Derived	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.