Overactive BladderNCT03923348
Pelvic Floor Muscle Training With Leva System for Urge Incontinence
A study testing Leva device in people with Overactive Bladder and Urge Urinary Incontinence, run by The Christ Hospital at 1 site in United States.
Trial summary
This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Overactive Bladder, Urge Urinary Incontinence, Mixed Urinary Incontinence
- What is being tested?
- Leva device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 4 May 2020
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years old
- Urinary incontinence for ≥ 3 months
- Reporting at least "moderate bother" on Item 2 on the UDI-6, "Do you experience urine leakage in related to the feeling of urgency" (on new patient paperwork)
- If mixed urinary incontinence, Medical Epidemiologic Social Aspect of Aging Urinary Incontinence Questionnaire (MESA) score indicating urge-predominant MUI (Urge subscale % > Stress subscale %)
- Presence of ≥ 1 UUI episode on 3-d bladder diary (see Appendix 2)
- Is the baseline bladder diary consistent with the patient's typical habits?
Show all 9Show fewer
- Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2 week wash-out period)
- Brink Score > 3 (see below)
- Access to smartphone technology, including iOS or Android™
Who cannot join
- Non-English speakers
- Severely impaired mobility or cognition
- Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
- Concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months
- Received intravesical botulinum injection within the previous 12 months
- History of implanted nerve stimulator for incontinence
Show all 18Show fewer
- History of prior sling or vaginal mesh placement
- Previous diagnosis of Interstitial cystitis
- Active pelvic organ malignancy
- History of pelvic radiation
- Urethral obstruction
- Urinary retention or prolonged catheter use
- Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months
- Untreated symptomatic urinary tract infection
- Unevaluated hematuria
- Medical instability
- Not available for follow-up in 6 months
- Participation in other research trials that could influence results of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.
Read the detailed description
Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined.
- Being tested
- Leva device
- Keywords
- female urinary incontinence, urge urinary incontinence, urgency, frequency, overactive bladder, pelvic floor muscle training, biofeedback
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leva deviceDevice
The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes.
| Study group | Role | What they receive |
|---|---|---|
| Leva Users | Experimental | Subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks. Receives: Device: Leva device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urogenital Distress Inventory
The Urogenital Distress Inventory (UDI) is a 19-item questionnaire assessing subjective symptoms of pelvic floor disorders including incontinence. The 19 items fall into one of three subscales (Irritative symptoms, Obstructive symptoms, and Stress Symptoms). . The subject responds to each item by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. For scoring, first each subscale score is calculated by finding the mean score of items within the subscale section, subtracting 1, and multiplying that by 100/3. Next, the subscale scores are summed to determine the overall UDI score with possible scores ranging from 0-300. High scores indicate greater symptoms severity.
Measured: Change from Baseline UDI score to 8 weeks and 6 months post-intervention
Secondary outcomes (2)
Incontinence Impact Questionnaire Short Form (IIQ-7)
Validated short-form version of the Incontinence Impact Questionnaire used to describe incontinence-related quality of life. It consists of 7 items assessing four general areas including travel, social, emotional, and physical activities. For each item, the subject responds by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. Scores are generated by finding the mean score for each item and multiplying that by 100/3. Higher scores indicate greater negative impact on quality of life.
Measured: Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention
Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary
A voiding diary is considered standard of care in the work-up of a patient with incontinence to better characterize real-life drinking and voiding habits. The number of urge urinary incontinence episodes is determined by adding up the incontinence episodes recorded by the patient that were associated with an urge to get to the bathroom. More incontinence episodes means a greater severity of incontinence
Measured: Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start6 Jun 2019
- Primary completion4 May 2020
- Study completion4 May 2020
Why it stopped: Slow Recruitment and Re-prioritizing of Sponsor-funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Model description
- Non-blinded non-comparative pilot trial in which subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Renovia, Inc.
- Responsible party
- Principal investigator, Anne Stachowicz, The Christ Hospital
- Investigators
- Anne M Stachowicz, MD, Principal investigator, Urogynecology Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923348
- Sponsor's protocol ID
- 18-71
- Status last verified
- Jun 2020
- First submitted
- 18 Mar 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.
PubMed 24007713Monteiro S, Riccetto C, Araujo A, Galo L, Brito N, Botelho S. Efficacy of pelvic floor muscle training in women with overactive bladder syndrome: a systematic review. Int Urogynecol J. 2018 Nov;29(11):1565-1573. doi: 10.1007/s00192-018-3602-x. Epub 2018 Apr 11.
PubMed 29644384Kammerer-Doak D, Rizk DE, Sorinola O, Agur W, Ismail S, Bazi T. Mixed urinary incontinence: international urogynecological association research and development committee opinion. Int Urogynecol J. 2014 Oct;25(10):1303-12. doi: 10.1007/s00192-014-2485-8. Epub 2014 Aug 5.
PubMed 25091925Lamin E, Parrillo LM, Newman DK, Smith AL. Pelvic Floor Muscle Training: Underutilization in the USA. Curr Urol Rep. 2016 Feb;17(2):10. doi: 10.1007/s11934-015-0572-0.
PubMed 26757904Rosenblatt P, Pulliam S, McKinney J, Sutherland R, Iglesias R. The leva incontinence system for the treatment of mild to moderate urinary incontinence: A pilot study. Female Pelvic Med Reconstr Surg.
Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994 Oct;3(5):291-306. doi: 10.1007/BF00451721.
PubMed 7841963Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
PubMed 7780440Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. doi: 10.1002/nau.21028. Epub 2011 May 11.
PubMed 21563210Jimenez-Cidre MA, Lopez-Fando L, Esteban-Fuertes M, Prieto-Chaparro L, Llorens-Martinez FJ, Salinas-Casado J, Castro-Diaz D, Muller-Arteaga C, Adot-Zurbano JM, Rodriguez-Escobar F, Gutierrez C, Arlandis-Guzman S, Bonillo-Garcia MA, Madurga-Patuel B, Leva-Vallejo M, Franco de Castro A, Peri-Cusi L, Conejero-Sugranes J, Jimenez-Calvo J, Rebollo P, Mora A. The 3-day bladder diary is a feasible, reliable and valid tool to evaluate the lower urinary tract symptoms in women. Neurourol Urodyn. 2015 Feb;34(2):128-32. doi: 10.1002/nau.22530. Epub 2013 Nov 22.
PubMed 24264859Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. doi: 10.1016/j.ajog.2004.11.015.
PubMed 15902162Brink CA, Sampselle CM, Wells TJ, Diokno AC, Gillis GL. A digital test for pelvic muscle strength in older women with urinary incontinence. Nurs Res. 1989 Jul-Aug;38(4):196-9.
PubMed 2748352
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
- ClinicalTrials.gov ID
- NCT03923348
- Acronym / sponsor ID
- 18-71
- Keywords
- female urinary incontinence, urge urinary incontinence, urgency, frequency, overactive bladder, pelvic floor muscle training, biofeedback
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Recruitment and Re-prioritizing of Sponsor-funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Collaborators
- Renovia, Inc.
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 22 Apr 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 is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.
Detailed description
Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-blinded non-comparative pilot trial in which subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Leva Users | Experimental | Device: Leva deviceSubjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-85 years old
- Urinary incontinence for ≥ 3 months
- Reporting at least "moderate bother" on Item 2 on the UDI-6, "Do you experience urine leakage in related to the feeling of urgency" (on new patient paperwork)
- If mixed urinary incontinence, Medical Epidemiologic Social Aspect of Aging Urinary Incontinence Questionnaire (MESA) score indicating urge-predominant MUI (Urge subscale % > Stress subscale %)
- Presence of ≥ 1 UUI episode on 3-d bladder diary (see Appendix 2)
Key exclusion criteria (18 listed)
- Non-English speakers
- Severely impaired mobility or cognition
- Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
- Concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months
- Received intravesical botulinum injection within the previous 12 months
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 deviceThe leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. | Device | Leva Users |
Primary outcome
Urogenital Distress Inventory
Time frame: Change from Baseline UDI score to 8 weeks and 6 months post-intervention
The Urogenital Distress Inventory (UDI) is a 19-item questionnaire assessing subjective symptoms of pelvic floor disorders including incontinence. The 19 items fall into one of three subscales (Irritative symptoms, Obstructive symptoms, and Stress Symptoms). . The subject responds to each item by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. For scoring, first each subscale score is calculated by finding the mean score of items within the subscale section, subtracting 1, and multiplying that by 100/3. Next, the subscale scores are summed to determine the overall UDI score with possible scores ranging from 0-300. High scores indicate greater symptoms severity.
2 secondary outcomes
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention
Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary
Time frame: Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention
Results and safety
The study was stopped early (reason given: Slow Recruitment and Re-prioritizing of Sponsor-funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Background: PubMed 24007713Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.
- Background: PubMed 29644384Monteiro S, Riccetto C, Araujo A, Galo L, Brito N, Botelho S. Efficacy of pelvic floor muscle training in women with overactive bladder syndrome: a systematic review. Int Urogynecol J. 2018 Nov;29(11):1565-1573. doi: 10.1007/s00192-018-3602-x. Epub 2018 Apr 11.
- Background: PubMed 25091925Kammerer-Doak D, Rizk DE, Sorinola O, Agur W, Ismail S, Bazi T. Mixed urinary incontinence: international urogynecological association research and development committee opinion. Int Urogynecol J. 2014 Oct;25(10):1303-12. doi: 10.1007/s00192-014-2485-8. Epub 2014 Aug 5.
- Background: PubMed 26757904Lamin E, Parrillo LM, Newman DK, Smith AL. Pelvic Floor Muscle Training: Underutilization in the USA. Curr Urol Rep. 2016 Feb;17(2):10. doi: 10.1007/s11934-015-0572-0.
- BackgroundRosenblatt P, Pulliam S, McKinney J, Sutherland R, Iglesias R. The leva incontinence system for the treatment of mild to moderate urinary incontinence: A pilot study. Female Pelvic Med Reconstr Surg.
- Background: PubMed 7841963Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994 Oct;3(5):291-306. doi: 10.1007/BF00451721.
- Background: PubMed 7780440Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
- Background: PubMed 21563210Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. doi: 10.1002/nau.21028. Epub 2011 May 11.
- Background: PubMed 24264859Jimenez-Cidre MA, Lopez-Fando L, Esteban-Fuertes M, Prieto-Chaparro L, Llorens-Martinez FJ, Salinas-Casado J, Castro-Diaz D, Muller-Arteaga C, Adot-Zurbano JM, Rodriguez-Escobar F, Gutierrez C, Arlandis-Guzman S, Bonillo-Garcia MA, Madurga-Patuel B, Leva-Vallejo M, Franco de Castro A, Peri-Cusi L, Conejero-Sugranes J, Jimenez-Calvo J, Rebollo P, Mora A. The 3-day bladder diary is a feasible, reliable and valid tool to evaluate the lower urinary tract symptoms in women. Neurourol Urodyn. 2015 Feb;34(2):128-32. doi: 10.1002/nau.22530. Epub 2013 Nov 22.
- Background: PubMed 15902162Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. doi: 10.1016/j.ajog.2004.11.015.
- Background: PubMed 2748352Brink CA, Sampselle CM, Wells TJ, Diokno AC, Gillis GL. A digital test for pelvic muscle strength in older women with urinary incontinence. Nurs Res. 1989 Jul-Aug;38(4):196-9.
- 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.
Anne M Stachowicz, MD principal investigator
Urogynecology Fellow
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 device in people with Overactive Bladder and Urge Urinary Incontinence, run by The Christ Hospital 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 9 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: stopped early, as of the sponsor's last update on 1 Jul 2020. 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?
The study was stopped early (reason given: Slow Recruitment and Re-prioritizing of Sponsor-funding). 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?
Urogenital Distress Inventory (time frame: Change from Baseline UDI score to 8 weeks and 6 months post-intervention). 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 NCT03923348, which also lists 11 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 1 Jul 2020.