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rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969368
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

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
Urinary Incontinence Device: rPMS device Procedure: Pelvic floor muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : June 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Evaluation of quality of life improvement using the UDI-6 questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 13 months ]
    Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.


Secondary Outcome Measures :
  1. Subject Satisfaction evaluation [ Time Frame: 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 [ Time Frame: 1 month ]
    Evaluation of therapy comfort after each treatment or training session using the questionnaire.

  3. Safety evaluation [ Time Frame: 13 months ]
    Incidence of adverse events (AE) associated with study device will be followed.



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03969368


Locations
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United States, Massachusetts
Boston Urogyn Active, not recruiting
Wellesley, Massachusetts, United States, 02481
United States, New Jersey
Center for Urogynecology and Reconstructive Surgery Active, not recruiting
Somerset, New Jersey, United States, 08873
United States, Pennsylvania
The Female Pelvic Health Center Recruiting
Newtown, Pennsylvania, United States, 18940
Contact: Stephanie Molden    215-869-3488    Info@fphcenter.com   
United States, Virginia
The Female Pelvic Medicine Institute Active, not recruiting
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
BTL Industries Ltd.
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Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03969368    
Other Study ID Numbers: BTL-099-U2
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020

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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:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders