Stress Urinary IncontinenceNCT04508153
Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
A study testing Leva Pelvic Digital Health System and Kegel exercises in people with Stress Urinary Incontinence, run by Renovia, Inc. at 3 sites in United States.
Trial summary
A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Leva Pelvic Digital Health System and Kegel exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2020to 1 Sep 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Capable of giving informed consent
- Possess a smartphone capable of interacting with the ObvioHealth and Renovia apps
- Self-reported SUI/SMUI symptoms of ≥ three months duration
- Diagnosis SMUI based on Medical, Epidemiologic and Social Aspects of Aging (MESA) stress symptom score (Percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
- English speaking
Show all 11Show fewer
- Postmenopausal, post hysterectomy, or willing to use an acceptable method of birth control for the duration of the study
- Able to complete a bladder diary using the ObvioHealth app
- Able to complete electronic surveys and upload data
- Willing to provide contact information and respond to remote contact: phone calls, text messages, email
- Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress UI using other modalities (i.e. will not wear a pessary, participate in pelvic floor Physical Therapy or surgery) during the first 8 weeks
Who cannot join
- Absence of a vagina, per patient report
- Reports seeing or feeling a vaginal bulge or sensation of vaginal bulge
- Diagnosis of any neuromuscular disease that may contribute to UI (i.e., multiple sclerosis, spinal cord injury, Parkinson's Disease, etc.)
- Non-ambulatory, per patient report
- Currently pregnant or <6 months post-partum per patient report
- Currently (or within the last 1 month) breast feeding
Show all 16Show fewer
- Prior surgery for stress UI
- Previous PFMT: 2 visits within the last 3 months under a supervised therapeutic plan of care
- Currently taking, or has taken within the last 2 months, medication to treat UI
- Prior augmentation cystoplasty or artificial sphincter
- Implanted nerve stimulator for urinary symptoms, active within the past 60 days
- Participation in another clinical study within 30 days of screening
- Impaired cognitive function per patient report and evaluation of medication list
- Contraindication to the use of a vaginal probe
- Unable to understand instructions on the use of the leva® PDHS
- Unable to operate a smartphone app with use of Bluetooth and Wi-Fi connectivity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico *** Virtual Trial May be enrolled from any US Location
Albuquerque, New Mexico, 87112
University of Alabama *** Virtual Trial May be enrolled from any US Location
Birmingham, Alabama, 35233
Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location
Irvine, California, 92618
About this study
Official title: A Prospective Randomized Trial Comparing Efficacy of Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for the Treatment of Stress Urinary Incontinence: A Remote Digital Trial
A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One group will receive routine care consisting of at-home Kegel exercises, and the other will be provided with a leva® device and instructions for use. Subjects in both groups will be assessed at baseline, then at 4 and 8 weeks for change and improvement of their symptoms. They will also be assessed at 6 and12 months after study completion.
Read the detailed description
This trial is entirely virtual. No office visits, specific locations, or physical examination will be required. Enrollment may occur from any location in the United States
- A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.
- Following completion of e-consent and screening, including an initial bladder diary and introductory phone call to review the study requirements, subjects are considered officially enrolled.
- A series of baseline assessments will be administered to all subjects to evaluate symptom severity, frequency and impact.
- Subjects will then be randomized to either the leva® arm or Kegel arm on a 1 to 1 ratio using block randomization. Prior to initiation of the trial, a randomization sequence will be generated by the ObvioHealth system. Participants will be automatically allocated the next available slot in the sequence at the time of their randomization and assigned to the leva® or Kegel group accordingly.
- Prior to beginning the program, subjects in the Kegel arm will receive printed instructions for PFMT with Kegel exercises. Subjects in the leva® arm will be shipped the leva® digital device, along with instructions for use and how to download the corresponding digital app. Day 1 of the study begins the day following receipt of materials.
- Study population: women with SUI or SMUI.
- The study requires no office visits. All participant data will be entered in the subject's smartphone using a custom designed mobile application. Participants will be able to interact with the app throughout the study period and will be presented with surveys and a voiding diary on a specified schedule during an 8-week treatment period. There will also be expected post-intervention follow up surveys at 6- and 12-months
- Using virtual recruiting, a total of up to 350 subjects will be enrolled in the trial.
- Subjects in both arms will have three scheduled phone calls with study staff during the first two weeks of treatment.
- Subjects can speak to the study staff at any time via an in-app chat function, the phone, or videoconference.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Leva Pelvic Digital Health System, Kegel exercises
- 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 Pelvic Digital Health SystemDevice
Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.
Kegel exercisesOther
Pelvic floor muscle training (PFMT), commonly referred to as "Kegel" exercises, is a first line conservative treatment for pelvic floor disorders, specifically stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (SMUI).
| Study group | Role | What they receive |
|---|---|---|
| Leva PDHS arm | Other | Upon randomization, subjects randomized to the leva® arm will receive the leva® PDHS, and instructions for how to download the smartphone app to facilitate use of the device. They will be instructed to use leva® based on the in-app training provided.
Within the app, subjects will be instructed to use the leva® device to perform PFMT according to the training program provided through the smartphone app associated with the device. This entails 2 ½ minute training sessions, three times daily, 7 days per week for a total of 8 weeks. Receives: Device: Leva Pelvic Digital Health System |
| Kegel arm | Other | Subjects randomized to the Kegel arm will be provided links to view instructions on how to perform PFMT (written instructions per the handout adapted from Voices for PFD, the patient advocacy arm of the American Urogynecologic Society), as well as an audio/visual didactic instructing them to perform Pelvic Floor Muscle Exercises (PFME) three times daily, seven days per week throughout the 8-week study period. Receives: Other: Kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Urogenital Distress Inventory (UDI-6)
UDI-6 is a validated questionnaire assessing symptom presence and degree of bother. It will be used to compare the degree of symptom change in the leva arm vs the Kegel arm within and between groups.
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Efficacy - Bladder diaries
Bladder diaries evaluating the average number of stress-incontinence episodes in 3 days will be compared within and between groups
Measured: Baseline and 8 weeks
Secondary outcomes (13)
Survey evaluations of incontinence Pelvic Organ Prolapse Distress Inventory (POPDI-6)
POPDI-6 to assess the impact that pelvic floor disorders have on the health related quality of life in women
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Patient Reported perception of general health Short Form-20 (SF-20)
SF-20 survey on the participants perception of their general health.
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Self-reported adherence
Visual Analog Score for self-reported adherence to the prescribed therapy, 0% = did not adhere to the prescribed treatment regimen/did not perform any Pelvic Floor exercises to 100% = adhered to the prescribed treatment regimen
Measured: 4 weeks, 8 weeks
Correlations between self-reported adherence and device reported adherence in the leva group
Self-reported adherence and Device-reported adherence in the Leva group will be correlated
Measured: 4 weeks, 8 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Monitored for adverse events and serious adverse events
Measured: Through study completion, an average of 1 year
Feedback on perception of treatment - likelihood of recommending to a friend
Visual Analog Score of likelihood of recommending to a friend Scale from 0-100%. 0%= Will not recommend to a friend to 100%=Will definitely recommend to a friend.
Measured: 4 weeks, 8 weeks
Feedback on perception of treatment - interest in surgical treatment
Visual Analog Score of interest in surgical treatment for urinary incontinence. Scale from 0-100%. 0%= Not interested at all in surgical treatment to 100%=Extremely interested in surgical treatment.
Measured: 4 weeks, 8 weeks
Survey evaluations of incontinence Colorectal-Anal Distress Inventory-8 (CRADI-8)
CRADI-8 to assess the impact that pelvic floor disorders have on the health related quality of life in women
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Floor Distress Inventory (PFDI-20)
PFDI-20 to assess the impact that pelvic floor disorders have on the health related quality of life in women
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)
PISQ-IR to assess the impact that pelvic floor disorders have on the health related quality of life in women
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Patient Global Impression of Severity (PGI-S)
PGI-S is the participants description of how their urinary tract condition is currently.
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Patient Global Impression of Improvement (PGI-I)
PGI-I is the participants description on how their urinary symptoms are now, compared with how they were before they began the study.
Measured: 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Floor Impact Questionnaire (PFIQ)
PFIQ to assess the impact that pelvic floor disorders have on the health related quality of life in women
Measured: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Oct 2020
- Primary completion23 Apr 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OBVIO HEALTH USA, Inc., University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Holly Richter, MD PhD, Principal investigator, University of Alabama at BirminghamMilena Weinstein, MD, Principal investigator, Massachusetts General HospitalGena Dunnivan, MD, Principal investigator, University of New MexicoNoelani M Guaderrama, MD, Principal investigator, Southern California Permanentae
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508153
- Sponsor's protocol ID
- OBVIO-REN-001
- Status last verified
- Jan 2021
- First submitted
- 5 Aug 2020
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months. Int Urogynecol J. 2024 Apr;35(4):803-810. doi: 10.1007/s00192-023-05721-z. Epub 2024 Jan 22.
PubMed 38252280Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months. Obstet Gynecol. 2023 Jan 1;141(1):199-206. doi: 10.1097/AOG.0000000000005036. Epub 2022 Nov 30.
PubMed 36701620Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2022 Apr 1;139(4):606-615. doi: 10.1097/AOG.0000000000004725. Epub 2022 Mar 10.
PubMed 35271539Weinstein MM, Pulliam SJ, Richter HE. Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design. Contemp Clin Trials. 2021 Jun;105:106406. doi: 10.1016/j.cct.2021.106406. Epub 2021 Apr 16.
PubMed 33866003
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Efficacy of Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for the Treatment of Stress Urinary Incontinence: A Remote Digital Trial
- ClinicalTrials.gov ID
- NCT04508153
- Acronym / sponsor ID
- OBVIO-REN-001
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Renovia, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OBVIO HEALTH USA, Inc., University of Alabama at Birmingham
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Aug 2020 (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 virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One group will receive routine care consisting of at-home Kegel exercises, and the other will be provided with a leva® device and instructions for use. Subjects in both groups will be assessed at baseline, then at 4 and 8 weeks for change and improvement of their symptoms. They will also be assessed at 6 and12 months after study completion.
Detailed description
This trial is entirely virtual. No office visits, specific locations, or physical examination will be required. Enrollment may occur from any location in the United States
- A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.
- Following completion of e-consent and screening, including an initial bladder diary and introductory phone call to review the study requirements, subjects are considered officially enrolled.
- A series of baseline assessments will be administered to all subjects to evaluate symptom severity, frequency and impact.
- Subjects will then be randomized to either the leva® arm or Kegel arm on a 1 to 1 ratio using block randomization. Prior to initiation of the trial, a randomization sequence will be generated by the ObvioHealth system. Participants will be automatically allocated the next available slot in the sequence at the time of their randomization and assigned to the leva® or Kegel group accordingly.
- Prior to beginning the program, subjects in the Kegel arm will receive printed instructions for PFMT with Kegel exercises. Subjects in the leva® arm will be shipped the leva® digital device, along with instructions for use and how to download the corresponding digital app. Day 1 of the study begins the day following receipt of materials.
- Study population: women with SUI or SMUI.
- The study requires no office visits. All participant data will be entered in the subject's smartphone using a custom designed mobile application. Participants will be able to interact with the app throughout the study period and will be presented with surveys and a voiding diary on a specified schedule during an 8-week treatment period. There will also be expected post-intervention follow up surveys at 6- and 12-months
- Using virtual recruiting, a total of up to 350 subjects will be enrolled in the trial.
- Subjects in both arms will have three scheduled phone calls with study staff during the first two weeks of treatment.
- Subjects can speak to the study staff at any time via an in-app chat function, the phone, or videoconference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.
| Arm | Type | Receives |
|---|---|---|
| Leva PDHS arm | Other | Device: Leva Pelvic Digital Health SystemUpon randomization, subjects randomized to the leva® arm will receive the leva® PDHS, and instructions for how to download the smartphone app to facilitate use of the device. They will be instructed to use leva® based on the in-app training provided. Within the app, subjects will be instructed to use the leva® device to perform PFMT according to the training program provided through the smartphone app associated with the device. This entails 2 ½ minute training sessions, three times daily, 7 days per week for a total of 8 weeks. |
| Kegel arm | Other | Other: Kegel exercisesSubjects randomized to the Kegel arm will be provided links to view instructions on how to perform PFMT (written instructions per the handout adapted from Voices for PFD, the patient advocacy arm of the American Urogynecologic Society), as well as an audio/visual didactic instructing them to perform Pelvic Floor Muscle Exercises (PFME) three times daily, seven days per week throughout the 8-week study period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18 years of age
- Capable of giving informed consent
- Possess a smartphone capable of interacting with the ObvioHealth and Renovia apps
- Self-reported SUI/SMUI symptoms of ≥ three months duration
- Diagnosis SMUI based on Medical, Epidemiologic and Social Aspects of Aging (MESA) stress symptom score (Percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
Key exclusion criteria (16 listed)
- Absence of a vagina, per patient report
- Reports seeing or feeling a vaginal bulge or sensation of vaginal bulge
- Diagnosis of any neuromuscular disease that may contribute to UI (i.e., multiple sclerosis, spinal cord injury, Parkinson's Disease, etc.)
- Non-ambulatory, per patient report
- Currently pregnant or <6 months post-partum per patient report
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 Pelvic Digital Health SystemPelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence. | Device | Leva PDHS arm |
| Kegel exercisesPelvic floor muscle training (PFMT), commonly referred to as "Kegel" exercises, is a first line conservative treatment for pelvic floor disorders, specifically stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (SMUI). | Other | Kegel arm |
Primary outcome
Efficacy - Urogenital Distress Inventory (UDI-6)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
UDI-6 is a validated questionnaire assessing symptom presence and degree of bother. It will be used to compare the degree of symptom change in the leva arm vs the Kegel arm within and between groups.
Efficacy - Bladder diaries
Time frame: Baseline and 8 weeks
Bladder diaries evaluating the average number of stress-incontinence episodes in 3 days will be compared within and between groups
13 secondary outcomes
Survey evaluations of incontinence Pelvic Organ Prolapse Distress Inventory (POPDI-6)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Patient Reported perception of general health Short Form-20 (SF-20)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Self-reported adherence
Time frame: 4 weeks, 8 weeks
Correlations between self-reported adherence and device reported adherence in the leva group
Time frame: 4 weeks, 8 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Time frame: Through study completion, an average of 1 year
Feedback on perception of treatment - likelihood of recommending to a friend
Time frame: 4 weeks, 8 weeks
Feedback on perception of treatment - interest in surgical treatment
Time frame: 4 weeks, 8 weeks
Survey evaluations of incontinence Colorectal-Anal Distress Inventory-8 (CRADI-8)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Floor Distress Inventory (PFDI-20)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Patient Global Impression of Improvement (PGI-I)
Time frame: 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Floor Impact Questionnaire (PFIQ)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 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 9 Dec 2021.
- Derived from this study: PubMed 38252280Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months. Int Urogynecol J. 2024 Apr;35(4):803-810. doi: 10.1007/s00192-023-05721-z. Epub 2024 Jan 22.
- Derived from this study: PubMed 36701620Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months. Obstet Gynecol. 2023 Jan 1;141(1):199-206. doi: 10.1097/AOG.0000000000005036. Epub 2022 Nov 30.
- Derived from this study: PubMed 35271539Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2022 Apr 1;139(4):606-615. doi: 10.1097/AOG.0000000000004725. Epub 2022 Mar 10.
- Derived from this study: PubMed 33866003Weinstein MM, Pulliam SJ, Richter HE. Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design. Contemp Clin Trials. 2021 Jun;105:106406. doi: 10.1016/j.cct.2021.106406. Epub 2021 Apr 16.
- 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
Milena Weinstein, MD principal investigator
Massachusetts General Hospital
Gena Dunnivan, MD principal investigator
University of New Mexico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leva Pelvic Digital Health System and Kegel exercises in people with Stress Urinary Incontinence, run by Renovia, Inc. at 3 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 11 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Efficacy - Urogenital Distress Inventory (UDI-6) (time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months). 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?
On the ClinicalTrials.gov record for NCT04508153, which also lists 4 linked publications.
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 9 Dec 2021.