Back to resultsEvaluation of a New Technology for the Treatment of Bladder Leakage in Women
Primary Purpose
Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Electrical stimulation
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring neuromuscular electrical stimulation, incontinence
Eligibility Criteria
Inclusion Criteria:
- Women
- Aged between 18 and 65
- GP determined urinary incontinence
Exclusion Criteria:
- Abnormal abdominal mass
- Clinical history of urinary retention problems
- Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia
- Pregnancy or given birth within the last three months
- Implanted pacemaker
- Recent pelvic surgery (within the last 12 months)
- Recent haemorrhage, haematoma and/or tissue damage to the vagina
- Undergoing any active therapy or review appointments for pelvic malignancy
- Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test)
- Manual dexterity insufficient to place the electrical stimulation device in the vagina
- Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson's Disease
- Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
- Insufficient cognitive ability to provide informed consent and/or participate in the study
- Unwillingness to participate in the study
Sites / Locations
- South Manchester GP Federation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electrical stimulation
Treatment As Usual
Arm Description
Neuromuscular electrical stimulation treatment
Usual GP treatment
Outcomes
Primary Outcome Measures
Condition specific quality of life
The primary outcome measure is Quality of Life measured through self-completion of the short form version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI). The Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity, and impact on urinary incontinence in research and clinical practice across the world.
Scoring & analysis: Question items include: frequency of urinary incontinence, amount of leakage and leak interference. The overall score is calculated from the sum of:
Leak frequency (minimum 0, maximum 5) Leak amount (minimum 0, maximum 6) Leak interference (minimum 0, maximum 10) Overall score is therefore between 0-21 - the higher the score the worse the outcome
Secondary Outcome Measures
Female Sexual Function Index (FSFI)
Brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
The individual domain scores and full scale (overall) score of the FSFI are derived by adding the scores of the individual items that comprise each domain and multiplying the sum by a domain factor. The six domain scores are added together to obtain the full-scale score. Within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month.
Desire: Minimum score 1 maximum 5 Arousal: Minimum score 0 maximum 5 Lubrication: Minimum score 0 maximum 5 Orgasm: Minimum score 0 maximum 5 Satisfaction: Minimum score 0 maximum 5 Pain: Minimum score 0 maximum 5
Score are multiplied by pre defined factors with a total range of between 2 and 36 where 36 is the most satisfied
Sexual dysfunction questionnaire
The International Urogynecological Association Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire to assess sexual function.
To score the sub-scales of which there are six in sexually active women and four in women who are not sexually active, half of the items must be answered, imputation is not recommended, and either mean calculation or transformed sum methods are recommended. There is a detailed process for calculating total scores that runs to three pages that has been published and validated in the International Urogynaecology Journal 2013
Patient Global Impression of Severity and of Improvement
A well-validated global assessment of improvement questionnaire for women with urinary stress incontinence
Scoring and analysis: The severity part of the scale is a single question asking the patient to rate how their urinary tract condition is now on a scale of 1 = Normal to 4 = Severe. The improvement part of the scale is a single question asking the patient to rate how their urinary tract condition is now compared with how it was before they started the study on a scale of 1 = very much better to 7 = very much worse
1-hour in-clinic provocative pad weight test
A standardised Food and Drug Administration recommended test
A standardised one hour test protocol is adopted from the recommendations of the International Continence Society.
Scoring and analysis: Volume of urine leaked over one hour calculated from the difference in pad weight pre and post 1-hour activities.
In terms of reporting the severity of urine loss is considered cured (<2g / hour), mild (2-10g / hour), moderate (11-50g/hour) and severe >50g/hour).
User experience Diaries
A diary that records user experience will be completed every two weeks over the 12 weeks of the study.
A second diary that records usability specific to treatment arm will be completed every other day in the first four weeks of the study and then every week for the following eight weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04059653
Brief Title
Evaluation of a New Technology for the Treatment of Bladder Leakage in Women
Official Title
Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID19 pandemic. Cannot recruit from primary care during pandemic
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of a new technology for the treatment of bladder leakage in women. The objective is to compare quality of life and other incontinence associated outcomes between women receiving routine General Practitioner (GP) prescribed care for urinary incontinence compared with those prescribed the electrical stimulation device.
Detailed Description
This United Kingdom study will comprise a single blind, primary care, post-market evaluation of a novel neuromuscular electrical stimulation treatment for urinary incontinence . Women with GP determined urinary incontinence (urgency, stress or mixed) will be randomised into one of two groups (intervention or control). The control group will receive routine care via their GP practice. The intervention group will receive the electrical stimulation device. Treatment will last for 12 weeks with a Quality of Life (QoL) primary end point immediately post treatment with a second phase to explore the impact of a further 12 weeks maintenance programme in the intervention group compared to routine care. There will be a further two year follow-up assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
Keywords
neuromuscular electrical stimulation, incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical stimulation
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation treatment
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Usual GP treatment
Intervention Type
Device
Intervention Name(s)
Electrical stimulation
Intervention Description
Electrical stimulation device
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
GP treatment as usual
Primary Outcome Measure Information:
Title
Condition specific quality of life
Description
The primary outcome measure is Quality of Life measured through self-completion of the short form version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI). The Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity, and impact on urinary incontinence in research and clinical practice across the world.
Scoring & analysis: Question items include: frequency of urinary incontinence, amount of leakage and leak interference. The overall score is calculated from the sum of:
Leak frequency (minimum 0, maximum 5) Leak amount (minimum 0, maximum 6) Leak interference (minimum 0, maximum 10) Overall score is therefore between 0-21 - the higher the score the worse the outcome
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Female Sexual Function Index (FSFI)
Description
Brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
The individual domain scores and full scale (overall) score of the FSFI are derived by adding the scores of the individual items that comprise each domain and multiplying the sum by a domain factor. The six domain scores are added together to obtain the full-scale score. Within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month.
Desire: Minimum score 1 maximum 5 Arousal: Minimum score 0 maximum 5 Lubrication: Minimum score 0 maximum 5 Orgasm: Minimum score 0 maximum 5 Satisfaction: Minimum score 0 maximum 5 Pain: Minimum score 0 maximum 5
Score are multiplied by pre defined factors with a total range of between 2 and 36 where 36 is the most satisfied
Time Frame
12 weeks
Title
Sexual dysfunction questionnaire
Description
The International Urogynecological Association Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire to assess sexual function.
To score the sub-scales of which there are six in sexually active women and four in women who are not sexually active, half of the items must be answered, imputation is not recommended, and either mean calculation or transformed sum methods are recommended. There is a detailed process for calculating total scores that runs to three pages that has been published and validated in the International Urogynaecology Journal 2013
Time Frame
12 weeks
Title
Patient Global Impression of Severity and of Improvement
Description
A well-validated global assessment of improvement questionnaire for women with urinary stress incontinence
Scoring and analysis: The severity part of the scale is a single question asking the patient to rate how their urinary tract condition is now on a scale of 1 = Normal to 4 = Severe. The improvement part of the scale is a single question asking the patient to rate how their urinary tract condition is now compared with how it was before they started the study on a scale of 1 = very much better to 7 = very much worse
Time Frame
12 weeks
Title
1-hour in-clinic provocative pad weight test
Description
A standardised Food and Drug Administration recommended test
A standardised one hour test protocol is adopted from the recommendations of the International Continence Society.
Scoring and analysis: Volume of urine leaked over one hour calculated from the difference in pad weight pre and post 1-hour activities.
In terms of reporting the severity of urine loss is considered cured (<2g / hour), mild (2-10g / hour), moderate (11-50g/hour) and severe >50g/hour).
Time Frame
12 weeks
Title
User experience Diaries
Description
A diary that records user experience will be completed every two weeks over the 12 weeks of the study.
A second diary that records usability specific to treatment arm will be completed every other day in the first four weeks of the study and then every week for the following eight weeks.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Health economics
Description
Although a formal Health Economic analysis is not part of the protocol, data to enable such an analysis will be collected. Participants will be asked to complete a diary of expenditure on incontinence products during the week preceding each assessment point.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women
Aged between 18 and 65
GP determined urinary incontinence
Exclusion Criteria:
Abnormal abdominal mass
Clinical history of urinary retention problems
Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia
Pregnancy or given birth within the last three months
Implanted pacemaker
Recent pelvic surgery (within the last 12 months)
Recent haemorrhage, haematoma and/or tissue damage to the vagina
Undergoing any active therapy or review appointments for pelvic malignancy
Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test)
Manual dexterity insufficient to place the electrical stimulation device in the vagina
Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson's Disease
Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
Insufficient cognitive ability to provide informed consent and/or participate in the study
Unwillingness to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackie Oldham, PhD
Organizational Affiliation
Univeristy of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheila McCorkindale, MBChB FRCGP
Organizational Affiliation
University of Manchester
Official's Role
Study Chair
Facility Information:
Facility Name
South Manchester GP Federation
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 2RN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23023996
Citation
Oldham J, Herbert J, McBride K. Evaluation of a new disposable "tampon like" electrostimulation technology (Pelviva(R)) for the treatment of urinary incontinence in women: a 12-week single blind randomized controlled trial. Neurourol Urodyn. 2013 Jun;32(5):460-6. doi: 10.1002/nau.22326. Epub 2012 Sep 28.
Results Reference
background
Links:
URL
https://www.femeda.com
Description
Improving quality of life for women. Providing groundbreaking technology for the treatment of urinary incontinence
Learn more about this trial
Evaluation of a New Technology for the Treatment of Bladder Leakage in Women
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