Urinary IncontinenceNCT03969368
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
A study testing rPMS device and Pelvic floor muscle training in people with Urinary Incontinence, run by BTL Industries Ltd. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- rPMS device and Pelvic floor muscle training
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2019to 23 Jun 2022
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Female Pelvic Health Center
Newtown, Pennsylvania, 18940
The Female Pelvic Medicine Institute
Richmond, Virginia, 23225
Center for Urogynecology and Reconstructive Surgery
Somerset, New Jersey, 08873
Boston Urogyn
Wellesley, Massachusetts, 02481
About this study
Official title: Randomized Trial of rPMS Pelvic Floor Stimulation Device 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.
- Conditions
- Urinary Incontinence
- Being tested
- rPMS device, Pelvic floor muscle training
- 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 rPMS device.
Pelvic floor muscle trainingProcedure or surgery
Control group will undergo a pelvic floor muscle training
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - rPMS Receives: Device: rPMS device |
| Control Group | Active comparator | Control group Receives: Procedure: Pelvic floor muscle training |
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 UDI-6 questionnaire
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.
Measured: 13 months
Evaluation of incontinence episodes using Bladder diary
Evaluation of change in incontinence episodes before and after the study treatment in both study groups.
Measured: 13 months
Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire
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.
Measured: 13 months
Evaluation of quality of life improvement using the Pad Usage Questionnaire
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.
Measured: 13 months
Evaluation of pelvic floor muscle strength
Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.
Measured: 13 months
Secondary outcomes (3)
Subject Satisfaction evaluation
Qualitative analysis of subject's opinion using a questionnaire. Subjects will be asked to describe the change and their satisfaction after the study treatment.
Measured: 13 months
Therapy comfort evaluation
Evaluation of therapy comfort after each treatment or training session using the questionnaire.
Measured: 1 month
Safety evaluation
Incidence of adverse events (AE) associated with study device will be followed.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Jun 2019
- Primary completion23 Jul 2021
- Study completion23 Jun 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT03969368
- Sponsor's protocol ID
- BTL-099-U2
- Status last verified
- Aug 2022
- First submitted
- 28 May 2019
- Last updated
- 31 Aug 2022
- 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 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03969368
- Acronym / sponsor ID
- BTL-099-U2
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 31 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: rPMS deviceTreatment with the investigational device - rPMS |
| Control Group | Active comparator | Procedure: Pelvic floor muscle trainingControl group |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 rPMS device. | Device | Treatment Group |
| Pelvic floor muscle trainingControl group will undergo a pelvic floor muscle training | Procedure or surgery | Control Group |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Subject Satisfaction evaluation
Time frame: 13 months
Therapy comfort evaluation
Time frame: 1 month
Safety evaluation
Time frame: 13 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 31 Aug 2022.
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
4 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 and Pelvic floor muscle training in people with Urinary Incontinence, run by BTL Industries Ltd. at 4 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 18 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 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 UDI-6 questionnaire (time frame: 13 months). The study lists 5 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 31 Aug 2022.