Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function
1 other identifier
interventional
45
1 country
5
Brief Summary
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedNovember 10, 2021
November 1, 2021
1.7 years
April 18, 2019
November 9, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Evaluation of quality of life improvement using the ICIQ-UI questionnaire
Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.
18 months
Evaluation of quality of life improvement using the FSFI questionnaire
Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.
18 months
Evaluation of quality of life improvement using the PISQ-12 questionnaire
Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement.
18 months
Secondary Outcomes (1)
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
18 months
Study Arms (1)
Treatment Group
EXPERIMENTALTreatment with the investigational device - rPMS
Interventions
Eligibility Criteria
You may qualify if:
- Age between 21 and 65 years
- Voluntarily signed informed consent form
- Suffers from UI
- Sexually active
- FSFI Questionnaire score ≤ 26.55 points
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Julene Samuels
Louisville, Kentucky, 40205, United States
Joseph Berenholz
Farmington Hills, Michigan, 48334, United States
Gynecological Solutions
Hillsborough, New Jersey, 08844, United States
Southern Urogynecology
West Columbia, South Carolina, 29169, United States
Hillcroft Medical Clinic
Sugar Land, Texas, 77479, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2019
First Posted
May 8, 2019
Study Start
May 1, 2019
Primary Completion
December 30, 2020
Study Completion
October 20, 2021
Last Updated
November 10, 2021
Record last verified: 2021-11