NCT03969368

Brief Summary

This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

May 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

May 28, 2019

Last Update Submit

August 30, 2022

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (5)

  • Evaluation of quality of life improvement using the UDI-6 questionnaire

    Evaluation of change in UDI-6 score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.

    13 months

  • Evaluation of incontinence episodes using Bladder diary

    Evaluation of change in incontinence episodes before and after the study treatment in both study groups.

    13 months

  • Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire

    Evaluation of change in ICIQ-LUTSqol score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.

    13 months

  • Evaluation of quality of life improvement using the Pad Usage Questionnaire

    Evaluation of change in Pad Usage Questionnaire before and after the study treatment in both study groups. Decrease in number of used pads will be considered as an improvement.

    13 months

  • Evaluation of pelvic floor muscle strength

    Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.

    13 months

Secondary Outcomes (3)

  • Subject Satisfaction evaluation

    13 months

  • Therapy comfort evaluation

    1 month

  • Safety evaluation

    13 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Treatment with the investigational device - rPMS

Device: rPMS device

Control Group

ACTIVE COMPARATOR

Control group

Procedure: Pelvic floor muscle training

Interventions

rPMS deviceDEVICE

Pelvic floor muscle contractions will be induced by the rPMS device.

Treatment Group
Pelvic floor muscle trainingPROCEDURE

Control group will undergo a pelvic floor muscle training

Control Group

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female aged 25-70 years
  • Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
  • Voluntarily signed informed consent form
  • Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
  • Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study

You may not qualify if:

  • Use of Botox® in the bladder or pelvic muscles in the last year
  • Use of Interstim® or similar device for the treatment of UI
  • Suffers from other types of urinary incontinence other than SUI, UUI, MUI
  • Pelvic organ prolapse grade 2 and higher
  • Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
  • Currently lactating
  • Cardiac pacemakers
  • Implanted defibrillators and/or neurostimulators
  • Electronic implants
  • Metal implants, including copper IUD
  • Drug pumps
  • Hemorrhagic conditions
  • Anticoagulation therapy
  • Fever
  • Pregnancy
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Boston Urogyn

Wellesley, Massachusetts, 02481, United States

Location

Center for Urogynecology and Reconstructive Surgery

Somerset, New Jersey, 08873, United States

Location

The Female Pelvic Health Center

Newtown, Pennsylvania, 18940, United States

Location

The Female Pelvic Medicine Institute

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 31, 2019

Study Start

June 1, 2019

Primary Completion

July 23, 2021

Study Completion

June 23, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

US(4)