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Completed

NCT Number: NCT03969368

rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

25 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Urogyn, Wellesley, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rPMS device

Device

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

pelvic floor muscle training

Procedure

Control group will undergo a pelvic floor muscle training

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 31, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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