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rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

Sponsor
BTL Industries Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03969368
Collaborator
(none)
60
Enrollment
4
Locations
2
Arms
30
Anticipated Duration (Months)
15
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: rPMS device
  • Procedure: Pelvic floor muscle training
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Treatment with the investigational device - rPMS

Device: rPMS device
Pelvic floor muscle contractions will be induced by the rPMS device.
Active Comparator: Control Group

Control group

Procedure: Pelvic floor muscle training
Control group will undergo a pelvic floor muscle training

Outcome Measures

Primary Outcome Measures

  1. Evaluation of quality of life improvement using the UDI-6 questionnaire [13 months]

    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.

  2. Evaluation of incontinence episodes using Bladder diary [13 months]

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

  3. Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire [13 months]

    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.

  4. Evaluation of quality of life improvement using the Pad Usage Questionnaire [13 months]

    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.

  5. Evaluation of pelvic floor muscle strength [13 months]

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

Secondary Outcome Measures

  1. Subject Satisfaction evaluation [13 months]

    Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment.

  2. Therapy comfort evaluation [1 month]

    Evaluation of therapy comfort after each treatment or training session using the questionnaire.

  3. Safety evaluation [13 months]

    Incidence of adverse events (AE) associated with study device will be followed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  • Following recent surgical procedures when muscle contraction may disrupt the healing process

  • Application over areas of the skin which lack normal sensation

  • Any disorders that the Investigator deems would interfere with study endpoints or subject safety

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Urogyn Wellesley Massachusetts United States 02481
2 Center for Urogynecology and Reconstructive Surgery Somerset New Jersey United States 08873
3 The Female Pelvic Health Center Newtown Pennsylvania United States 18940
4 The Female Pelvic Medicine Institute Richmond Virginia United States 23225

Sponsors and Collaborators

  • BTL Industries Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BTL Industries Ltd.
ClinicalTrials.gov Identifier:
NCT03969368
Other Study ID Numbers:
  • BTL-099-U2
First Posted:
May 31, 2019
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Urinary Incontinence
Enuresis

Study Results

No Results Posted as of Jan 29, 2021