Fecal IncontinenceNCT04027335
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
A study testing leva in people with Fecal Incontinence, run by Renovia, Inc. at 1 site in United States.
Trial summary
Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- leva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 30 Apr 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 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
- Ambulatory
Who cannot join
- Absence of a vagina
- Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
- Current or past diagnosis of colorectal or anal malignancy
- Diagnosis of inflammatory bowel disease
- Current or history of rectovaginal fistula or cloacal defect
- Rectal prolapse (mucosal or full thickness)
Show all 19Show fewer
- Prior removal or diversion of any portion of colon or rectum
- Prior pelvic floor or abdominal radiation
- Refusal or inability to provide written consent
- Inability to utilize smart phone technology ("app" use)
- Fecal impaction by exam
- Stage 3 or 4 pelvic organ prolapse
- Incontinence only to flatus
- Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
- Childbirth within the last 6 months
- Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
- Chronic abdominal pain in the absence of diarrhea
- Presence of an active (turned on) sacral neuromodulator within the last 6 months
- Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women
Read the detailed description
Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.
Subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.
Adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.
Subjects are expected to participate in at least 80% of the weekly exercises (11 weekly).
Subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.
Following 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. Adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months
- Conditions
- Fecal Incontinence
- Being tested
- leva
- Keywords
- Fecal incontinence, Women
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levaDevice
Vaginal device used for pelvic floor muscle exercises
| Study group | Role | What they receive |
|---|---|---|
| Leva Arm | Experimental | Subjects will undergo training in the use of a vaginal device and its associated app, to be used twice daily to perform pelvic floor muscle exercises guided by the device/app for 10 weeks. Receives: Device: leva |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. Mark's Incontinence Score
Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms
Measured: Baseline to 10 weeks
Secondary outcomes (3)
Change in Fecal incontinence episodes
Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.
Measured: Baseline to 10 weeks
Fecal Incontinence Quality of Life Scale (FIQoL)
Validated Survey evaluates four areas- coping, depression, lifestyle and embarrassment. Each area is scored from 1-5. Higher numbers indicate more severe symptoms. Area scores are not combined
Measured: Change in score from baseline to 10 weeks
Cumulative adherence correlation with change in St. Mark's score
Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)
Measured: baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start27 Aug 2019
- Primary completion21 Dec 2020
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holly Richter, MD PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027335
- Sponsor's protocol ID
- REN-17
- Status last verified
- Jan 2021
- First submitted
- 18 Jul 2019
- Last updated
- 20 Jan 2021
- 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
- ClinicalTrials.gov ID
- NCT04027335
- Acronym / sponsor ID
- REN-17
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Renovia, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 19 Jul 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.
Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women
Detailed description
Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.
Subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.
Adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.
Subjects are expected to participate in at least 80% of the weekly exercises (11 weekly).
Subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.
Following 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. Adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months
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: levaSubjects will undergo training in the use of a vaginal device and its associated app, to be used twice daily to perform pelvic floor muscle exercises guided by the device/app for 10 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
- Ambulatory
Key exclusion criteria (19 listed)
- Absence of a vagina
- Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
- Current or past diagnosis of colorectal or anal malignancy
- Diagnosis of inflammatory bowel disease
- Current or history of rectovaginal fistula or cloacal defect
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 |
|---|---|---|
| levaVaginal device used for pelvic floor muscle exercises | Device | Leva Arm |
Primary outcome
St. Mark's Incontinence Score
Time frame: Baseline to 10 weeks
Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms
3 secondary outcomes
Change in Fecal incontinence episodes
Time frame: Baseline to 10 weeks
Fecal Incontinence Quality of Life Scale (FIQoL)
Time frame: Change in score from baseline to 10 weeks
Cumulative adherence correlation with change in St. Mark's score
Time frame: baseline to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- 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.
Holly Richter, MD PhD principal investigator
University of Alabama at Birmingham
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 in people with Fecal 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 3 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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?
Results are not available in the source record.
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?
St. Mark's Incontinence Score (time frame: Baseline to 10 weeks). 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 20 Jan 2021.