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Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function

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: NCT03942484
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

Brief Summary:
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: rPMS device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

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 device.




Primary Outcome Measures :
  1. Evaluation of quality of life improvement using the ICIQ-UI questionnaire [ Time Frame: 18 months ]
    Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.

  2. Evaluation of quality of life improvement using the FSFI questionnaire [ Time Frame: 18 months ]
    Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.

  3. Evaluation of quality of life improvement using the PISQ-12 questionnaire [ Time Frame: 18 months ]
    Evaluation of change in PISQ-12 score. Decrease of the score will be considered as an improvement


Secondary Outcome Measures :
  1. Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed. [ Time Frame: 18 months ]
    Incidence of adverse events (AE) associated with study device will be followed.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 21 and 65 years
  • Voluntarily signed informed consent form
  • Suffers from UI
  • Sexually active
  • FSFI Questionnaire score ≤ 26.55 points

Exclusion Criteria:

  • Suffers from other types of urinary incontinence other than SUI, UUI, MUI
  • 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

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): NCT03942484


Locations
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United States, Kentucky
Julene Samuels Not yet recruiting
Louisville, Kentucky, United States, 40205
Contact: Julene Samuels, MD    502-897-9411      
United States, Michigan
Joseph Berenholz Not yet recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Joseph Berenholz, MD    248-514-0771      
United States, New Jersey
Gynecological Solutions Not yet recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Carolyn DeLucia, MD    908-431-5849      
United States, South Carolina
Southern Urogynecology Not yet recruiting
West Columbia, South Carolina, United States, 29169
Contact: Andrea Pezzella, MD    803-457-7000      
United States, Texas
Hillcroft Medical Clinic Not yet recruiting
Sugar Land, Texas, United States, 77479
Contact: Kimberly Evans, MD    713-273-5804      
Sponsors and Collaborators
BTL Industries Ltd.

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Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03942484     History of Changes
Other Study ID Numbers: BTL-099-S
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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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: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders