Stress Urinary IncontinenceNCT03632447
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
A study testing Leva and PFDx in people with Stress Urinary Incontinence and Mixed Urinary Incontinence, run by Renovia, Inc. at 7 sites in United States.
Trial summary
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Mixed Urinary Incontinence
- What is being tested?
- Leva and PFDx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Oct 2018to 1 Oct 2019
- 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 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving informed consent.
- Self-reported stress-type UI symptoms of >= three months duration
- Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score).
- UDI-6 score >/= 25
- Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks.
Who cannot join
- Absence of a vagina.
- Age <18 years.
- Stage 3-4 pelvic organ prolapse (as determined by POP-Q).
- Diagnosis of any neuromuscular disease.
- Non-ambulatory.
- Currently pregnant or <12 months post-partum.
Show all 16Show fewer
- </= 3 months after failed surgery for stress urinary incontinence.
- Previous pelvic floor muscle training (PFMT) within the last 12 months under a supervised therapeutic plan of care.
- Currently taking, or has taken within the last 2 months, medication to treat urinary incontinence.
- Prior augmentation cystoplasty or artificial sphincter.
- Implanted nerve stimulator for urinary symptoms.
- Participation in another clinical study within 30 days of screening.
- Impaired cognitive function.
- Contraindication to the use of a vaginal probe.
- Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health System.
- Unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cedars-Sinai Medical Group
Beverly Hills, California, 90211
University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Univeristy of Oklahoma
Oklahoma City, Oklahoma, 73104
Urology San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
Read the detailed description
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.
- Being tested
- Leva, PFDx
- Keywords
- Digital Health, Female
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevaDevice
Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.
PFDxDevice
All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.
| Study group | Role | What they receive |
|---|---|---|
| Leva Arm | Experimental | Subjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months. Receives: Device: Leva; Device: PFDx |
| Kegel Arm | Active comparator | Subjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. Receives: Device: PFDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGI-I
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."
Measured: 8 weeks after randomization
UDI-6
Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms
Measured: 8 weeks after randomization
Secondary outcomes (1)
3-day voiding diary
An objective evaluation of urinary incontinence
Measured: 8 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start24 Oct 2018
- Primary completion1 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632447
- Sponsor's protocol ID
- REN-05
- Status last verified
- Jul 2019
- First submitted
- 13 Aug 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03632447
- Acronym / sponsor ID
- REN-05
- Keywords
- Digital Health, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Renovia, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 15 Aug 2018 (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.
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
Detailed description
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leva Arm | Experimental | Device: Leva, Device: PFDxSubjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months. |
| Kegel Arm | Active comparator | Device: PFDxSubjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable of giving informed consent.
- Self-reported stress-type UI symptoms of >= three months duration
- Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score).
- UDI-6 score >/= 25
- Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks.
Key exclusion criteria (16 listed)
- Absence of a vagina.
- Age <18 years.
- Stage 3-4 pelvic organ prolapse (as determined by POP-Q).
- Diagnosis of any neuromuscular disease.
- Non-ambulatory.
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 |
|---|---|---|
| LevaSubjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises. | Device | Leva Arm |
| PFDxAll subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises. | Device | Kegel Arm, Leva Arm |
Primary outcome
PGI-I
Time frame: 8 weeks after randomization
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."
UDI-6
Time frame: 8 weeks after randomization
Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms
1 secondary outcome
3-day voiding diary
Time frame: 8 weeks after randomization
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leva and PFDx in people with Stress Urinary Incontinence and Mixed Urinary Incontinence, run by Renovia, Inc. at 7 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 16 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
PGI-I (time frame: 8 weeks after randomization). The study lists 2 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 8 Oct 2020.