Urinary IncontinenceNCT03942484
Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
A study testing rPMS device in people with Urinary Incontinence, run by BTL Industries Ltd. at 5 sites in United States.
Trial summary
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- rPMS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2019to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years
- Voluntarily signed informed consent form
- Suffers from UI
- Sexually active
- FSFI Questionnaire score ≤ 26.55 points
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Joseph Berenholz
Farmington Hills, Michigan, 48334
Gynecological Solutions
Hillsborough, New Jersey, 08844
Julene Samuels
Louisville, Kentucky, 40205
Hillcroft Medical Clinic
Sugar Land, Texas, 77479
Southern Urogynecology
West Columbia, South Carolina, 29169
About this study
Official title: Efficacy of Repetitive Pulse Magnetic Stimulation 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.
- Conditions
- Urinary Incontinence
- Being tested
- rPMS device
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPMS deviceDevice
Pelvic floor muscle contractions will be induced by the device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - rPMS Receives: Device: rPMS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (1)
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
Incidence of adverse events (AE) associated with study device will be followed.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 May 2019
- Primary completion30 Dec 2020
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942484
- Sponsor's protocol ID
- BTL-099-S
- Status last verified
- Nov 2021
- First submitted
- 18 Apr 2019
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function
- ClinicalTrials.gov ID
- NCT03942484
- Acronym / sponsor ID
- BTL-099-S
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: rPMS deviceTreatment with the investigational device - rPMS |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 21 and 65 years
- Voluntarily signed informed consent form
- Suffers from UI
- Sexually active
- FSFI Questionnaire score ≤ 26.55 points
Key exclusion criteria (13 listed)
- Suffers from other types of urinary incontinence other than SUI, UUI, MUI
- Currently lactating
- Cardiac pacemakers
- Implanted defibrillators and/or neurostimulators
- Electronic implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rPMS devicePelvic floor muscle contractions will be induced by the device. | Device | Treatment Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rPMS device in people with Urinary Incontinence, run by BTL Industries Ltd. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life improvement using the ICIQ-UI questionnaire (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.