Stress Urinary IncontinenceNCT03536923

Use of the Leva Incontinence System in Treating Bladder Incontinence.

A study testing Leva Incontinence System For Pelvic Floor Muscle strengthening in people with Stress Urinary Incontinence, run by Renovia, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 89 years, women only
Conditions the study is for: Stress Urinary Incontinence
What is being tested?: Leva Incontinence System For Pelvic Floor Muscle strengthening
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2017to 20 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects must be female.
Subjects must be capable of giving informed consent.
Subjects should be at least 18 years of age and less than 89 years of age
Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

Who cannot join

Absence of a vagina.
Positive drug or alcohol test at the screening visit.
Post-menopausal defined as absence of a period for over 12 months.
Pregnancy or being less than 12 months post-partum.
Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
Symptoms of stage II or greater pelvic organ prolapse.

Show all 17Show fewer

BMI >31 kg/m2.
Diagnosis of any neurological disorder.
Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
Prior pelvic radiation.
Current or recurrent vaginal infections (>three per year).
Painful bladder syndrome, active or chronic pelvic pain.
Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
Currently taking medication to treat incontinence.
Impaired cognitive function.
Unable to tolerate use of the leva device.

Trial locations and contacts

1 site in 1 country.

United States1 site

New England Spine Center
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Conditions: Stress Urinary Incontinence
Being tested: Leva Incontinence System For Pelvic Floor Muscle strengthening
Keywords: 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.

Leva Incontinence System For Pelvic Floor Muscle strengtheningDevice
The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.

Study groups in NCT03536923
Study group	Role	What they receive
Leva Arm	Experimental	Subjects will use the leva device twice daily to perform pelvic floor muscle exercises Receives: Device: Leva Incontinence System For Pelvic Floor Muscle strengthening

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.
Measured: 6 weeks

Secondary outcomes (3)

Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement.
Measured: 6 weeks
Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree).
Measured: At 6 weeks
Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can "hold" the lift was recorded
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201720 Oct 2017

First posted25 May 2018
Study start10 Apr 2017
Primary completion12 Aug 2017
Study completion20 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03536923
Sponsor's protocol ID: REN-01
Status last verified: Dec 2018
First submitted: 13 May 2018
Last updated: 12 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the Leva Incontinence System in Treating Bladder Incontinence.
ClinicalTrials.gov ID: NCT03536923
Acronym / sponsor ID: REN-01
Conditions: Stress Urinary Incontinence
Keywords: Female
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Renovia, Inc.Industry (pharma, biotech, devices)
Study start: 10 Apr 2017 (actual)
Primary completion: 12 Aug 2017 (actual)
Study completion: 20 Oct 2017 (actual)
First posted: 25 May 2018 (actual)
Results: Posted 12 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Leva Arm	Experimental	Device: Leva Incontinence System For Pelvic Floor Muscle strengtheningSubjects will use the leva device twice daily to perform pelvic floor muscle exercises

Who may qualify

Ages: 18 to 89 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects must be female.
Subjects must be capable of giving informed consent.
Subjects should be at least 18 years of age and less than 89 years of age
Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

Key exclusion criteria (17 listed)

Absence of a vagina.
Positive drug or alcohol test at the screening visit.
Post-menopausal defined as absence of a period for over 12 months.
Pregnancy or being less than 12 months post-partum.
Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).

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
Leva Incontinence System For Pelvic Floor Muscle strengtheningThe leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.	Device	Leva Arm

Primary outcome

Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
Time frame: 6 weeks
A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.

3 secondary outcomes

Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Time frame: 6 weeks
Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Time frame: At 6 weeks
Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Time frame: 6 weeks

Results and safety

Results posted to the registry on 12 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Leva Arm	23	23

Primary outcome: Symptoms of Urinary Incontinence at Baseline and at 6 Weeks

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Leva Arm n = 23
Baseline	27.5 (16.9)
Final (week 6)	1.1 (2.9)

Leva Arm: p = 0.0001, t-test, 1 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a 6-week period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leva Arm	0 of 23 (0%)	3 of 23 (13%)	0 of 23

Limitations and caveats (from the sponsor): This is a single-arm, proof of concept trial. As such it lacks a comparison arm, planned in future studies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Stress Urinary Incontinence

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

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.

Robert Rosenberg, MD principal investigator

New England Spine Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Leva Incontinence System For Pelvic Floor Muscle strengthening in people with Stress Urinary Incontinence, run by Renovia, Inc. at 1 site 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 4 inclusion and 17 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 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Symptoms of Urinary Incontinence at Baseline and at 6 Weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03536923.

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 12 Dec 2018.