Urinary IncontinenceNCT04059653
Evaluation of a New Technology for the Treatment of Bladder Leakage in Women
A study testing Electrical stimulation and Treatment as usual in people with Urinary Incontinence and Urinary Incontinence, Stress, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
- What is being tested?
- Electrical stimulation and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to 30 Jun 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Aged between 18 and 65
- GP determined urinary incontinence
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Manchester GP Federation
Manchester, Greater Manchester, M20 2RN
About this study
Official title: Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial
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.
Read the 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.
- Being tested
- Electrical stimulation, Treatment as usual
- Keywords
- neuromuscular electrical stimulation, incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationDevice
Electrical stimulation device
Treatment as usualOther
GP treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | Neuromuscular electrical stimulation treatment Receives: Device: Electrical stimulation |
| Treatment As Usual | Active comparator | Usual GP treatment Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (5)
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start6 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: COVID19 pandemic. Cannot recruit from primary care during pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jackie Oldham, University of Manchester
- Investigators
- Jackie Oldham, PhD, Principal investigator, Univeristy of ManchesterSheila McCorkindale, MBChB FRCGP, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059653
- Sponsor's protocol ID
- R123366
- Other IDs
- 223014
- Status last verified
- Jul 2020
- First submitted
- 7 Aug 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23023996
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04059653
- Acronym / sponsor ID
- R123366
- Keywords
- neuromuscular electrical stimulation, incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 pandemic. Cannot recruit from primary care during pandemic
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Device: Electrical stimulationNeuromuscular electrical stimulation treatment |
| Treatment As Usual | Active comparator | Other: Treatment as usualUsual GP treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women
- Aged between 18 and 65
- GP determined urinary incontinence
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Electrical stimulationElectrical stimulation device | Device | Electrical stimulation |
| Treatment as usualGP treatment as usual | Other | Treatment As Usual |
Primary outcome
Condition specific quality of life
Time frame: 12 weeks
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
5 secondary outcomes
Female Sexual Function Index (FSFI)
Time frame: 12 weeks
Sexual dysfunction questionnaire
Time frame: 12 weeks
Patient Global Impression of Severity and of Improvement
Time frame: 12 weeks
1-hour in-clinic provocative pad weight test
Time frame: 12 weeks
User experience Diaries
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID19 pandemic. Cannot recruit from primary care during pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 23023996Oldham 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.
- Improving quality of life for women. Providing groundbreaking technology for the treatment of urinary incontinenceLink provided by the sponsor.
- 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.
Jackie Oldham, PhD principal investigator
Univeristy of Manchester
Sheila McCorkindale, MBChB FRCGP study chair
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation and Treatment as usual in people with Urinary Incontinence and Urinary Incontinence, Stress, run by University of Manchester at 1 site in United Kingdom.
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 14 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 23 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 Kingdom. 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: COVID19 pandemic. Cannot recruit from primary care during pandemic). 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?
Condition specific quality of life (time frame: 12 weeks). 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 NCT04059653, which also lists 1 linked publication.
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 23 Jul 2020.