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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03942484

Enrollment

Registered

2019-05-08

Start date

2019-05-01

Completion date

2021-10-20

Last updated

2021-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

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

Interventions

DEVICErPMS device

Pelvic floor muscle contractions will be induced by the device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of quality of life improvement using the ICIQ-UI questionnaire	18 months	Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.
Evaluation of quality of life improvement using the FSFI questionnaire	18 months	Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.
Evaluation of quality of life improvement using the PISQ-12 questionnaire	18 months	Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement.

Secondary

Measure	Time frame	Description
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.	18 months	Incidence of adverse events (AE) associated with study device will be followed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026