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出境医 / 临床实验 / Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence

Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: leva Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
Actual Study Start Date : August 27, 2019
Actual Primary Completion Date : December 21, 2020
Estimated Study Completion Date : April 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Leva Arm
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.
Device: leva
Vaginal device used for pelvic floor muscle exercises

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Fecal incontinence episodes [ Time Frame: Baseline to 10 weeks ]
    Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.

  2. Fecal Incontinence Quality of Life Scale (FIQoL) [ Time Frame: Change in score from baseline to 10 weeks ]
    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

  3. Cumulative adherence correlation with change in St. Mark's score [ Time Frame: baseline to 10 weeks ]
    Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Subject must have a vagina
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. 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
  3. Ambulatory

Exclusion Criteria:

  1. Absence of a vagina
  2. Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
  3. Current or past diagnosis of colorectal or anal malignancy
  4. Diagnosis of inflammatory bowel disease
  5. Current or history of rectovaginal fistula or cloacal defect
  6. Rectal prolapse (mucosal or full thickness)
  7. Prior removal or diversion of any portion of colon or rectum
  8. Prior pelvic floor or abdominal radiation
  9. Refusal or inability to provide written consent
  10. Inability to utilize smart phone technology ("app" use)
  11. Fecal impaction by exam
  12. Stage 3 or 4 pelvic organ prolapse
  13. Incontinence only to flatus
  14. Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
  15. Childbirth within the last 6 months
  16. Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
  17. Chronic abdominal pain in the absence of diarrhea
  18. Presence of an active (turned on) sacral neuromodulator within the last 6 months
  19. Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.
Contacts and Locations

Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Renovia, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Holly Richter, MD PhD University of Alabama at Birmingham
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE August 27, 2019
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
St. Mark's Incontinence Score [ Time Frame: Baseline to 10 weeks ]
Validated survey of fecal incontinence severity, score ranges from 0-24
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • Change in Fecal incontinence episodes [ Time Frame: Baseline to 10 weeks ]
    Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.
  • Fecal Incontinence Quality of Life Scale (FIQoL) [ Time Frame: Change in score from baseline to 10 weeks ]
    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
  • Cumulative adherence correlation with change in St. Mark's score [ Time Frame: baseline to 10 weeks ]
    Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Change in Fecal incontinence episodes [ Time Frame: Baseline to 10 weeks ]
    Change in the number of fecal incontinence episodes (%) recorded on a two week diary of fecal incontinence episodes
  • Fecal Incontinence Quality of Life Score [ Time Frame: Change in score from baseline to 10 weeks ]
    Validated Survey evaluates four areas- coping, depression, lifestyle and embarrassment
  • Cumulative adherence correlation with change in St. Mark's score [ Time Frame: baseline to 10 weeks ]
    Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
Official Title  ICMJE Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fecal Incontinence
Intervention  ICMJE Device: leva
Vaginal device used for pelvic floor muscle exercises
Study Arms  ICMJE Experimental: Leva Arm
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.
Intervention: Device: leva
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 6, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
30
Estimated Study Completion Date  ICMJE April 30, 2021
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18 years
  2. 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
  3. Ambulatory

Exclusion Criteria:

  1. Absence of a vagina
  2. Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
  3. Current or past diagnosis of colorectal or anal malignancy
  4. Diagnosis of inflammatory bowel disease
  5. Current or history of rectovaginal fistula or cloacal defect
  6. Rectal prolapse (mucosal or full thickness)
  7. Prior removal or diversion of any portion of colon or rectum
  8. Prior pelvic floor or abdominal radiation
  9. Refusal or inability to provide written consent
  10. Inability to utilize smart phone technology ("app" use)
  11. Fecal impaction by exam
  12. Stage 3 or 4 pelvic organ prolapse
  13. Incontinence only to flatus
  14. Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
  15. Childbirth within the last 6 months
  16. Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
  17. Chronic abdominal pain in the absence of diarrhea
  18. Presence of an active (turned on) sacral neuromodulator within the last 6 months
  19. Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Subject must have a vagina
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027335
Other Study ID Numbers  ICMJE REN-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Renovia, Inc.
Study Sponsor  ICMJE Renovia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Holly Richter, MD PhD University of Alabama at Birmingham
PRS Account Renovia, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP