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OpenTrials
Completed

NCT Number: NCT03942484

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

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

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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

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Julene Samuels, Louisville, Kentucky, 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

  • 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

Treatment and study plan

rPMS device

Device

Pelvic floor muscle contractions will be induced by the device.

Primary outcomes

  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. Increase of the score will be considered as an improvement.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 8, 2019
Registry last updated
Nov 10, 2021

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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