Urinary Stress IncontinencePhase 2KEAT F1NCT00762593
Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
A Phase 2 study testing transvaginal electrical stimulation device in people with Urinary Stress Incontinence, run by Akontis at 1 site in France.
Trial summary
To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- transvaginal electrical stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Oct 2008
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years old
- Signed informed consent form
- Women with urinary stress incontinence defined as follow
- Involuntary loss of urine during increased abdominal pressure. In case of mix urinary incontinence (i.e., stress urinary incontinence associated to urge urinary incontinence) the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogic scale is higher for stress incontinence than for urge incontinence symptoms.
- closure pressure between 10 and 60 cm H2O
- the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogical scale is higher than 40/100
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- Patients never treated with transvaginal electrical stimulation
- Vaginal muscle strength less than 3/5 on the muscular testing
- Positive Pad test (>2 g of leakage measure by pad test with standardised bladder volume)
Who cannot join
- Patient refusing to sign the consent form
- patient unable to understand or follow the protocol
- inadequate cognitive ability
- patient participating in another research protocol within the 3 previous months
- pregnancy
- women with no contraception
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- pacemaker
- history of recent (< 1 year) transvaginal electrical stimulation treatment at home
- urinary incontinence other than stress incontinence
- neurological disease
- permanent metrorrhagia
- ongoing urinary tract infections
- vaginal prolapse > 2
- untreated atrophic vaginitis
- history of surgical treatment for urinary stress incontinence or genital prolapse
- recent pelvic surgery (<6 months)
- anatomic defect that preclude the use of the device
- genitourinary cancer or colic cancer
- patient already treated for urinary stress incontinence
- Recent oestrogen treatment (less than 3 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women
- Conditions
- Urinary Stress Incontinence
- Being tested
- transvaginal placebo device, transvaginal electrical stimulation device
- Keywords
- urinary stress incontinence, urinary stress incontinence in women
- 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.
transvaginal placebo deviceDevice
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
transvaginal electrical stimulation deviceDevice
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks Receives: Device: transvaginal electrical stimulation device |
| 2 | Placebo comparator | Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks Receives: Device: transvaginal placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
Measured: 8 weeks
Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks
Measured: 8 weeks
Secondary outcomes (6)
Urodynamic investigation
Measured: 4 and 8 weeks
Standardised Pad test
Measured: 4 and 8 weeks
Number of severe urinary stress incontinence episodes
Measured: 4 and 8 weeks
Number of sanitary napkins used
Measured: 4 and 8 weeks
Leakage index
Measured: 4 and 8 weeks
Subjective appreciation of patients
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akontis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762593
- Sponsor's protocol ID
- KEAT F1
- Acronym
- KEAT F1
- Status last verified
- Oct 2008
- First submitted
- 29 Sep 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT00762593
- Acronym / sponsor ID
- KEAT F1 / KEAT F1
- Conditions
- Urinary Stress Incontinence
- Keywords
- urinary stress incontinence, urinary stress incontinence in women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AkontisIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 30 Sep 2008 (estimated)
- 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.
To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: transvaginal electrical stimulation devicetransvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks |
| 2 | Placebo comparator | Device: transvaginal placebo deviceUse of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >=18 years old
- Signed informed consent form
- Women with urinary stress incontinence defined as follow
- Involuntary loss of urine during increased abdominal pressure. In case of mix urinary incontinence (i.e., stress urinary incontinence associated to urge urinary incontinence) the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogic scale is higher for stress incontinence than for urge incontinence symptoms.
- closure pressure between 10 and 60 cm H2O
Key exclusion criteria (20 listed)
- Patient refusing to sign the consent form
- patient unable to understand or follow the protocol
- inadequate cognitive ability
- patient participating in another research protocol within the 3 previous months
- pregnancy
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 |
|---|---|---|
| transvaginal placebo deviceUse of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks | Device | 2 |
| transvaginal electrical stimulation deviceUse of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks | Device | 1 |
Primary outcome
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
Time frame: 8 weeks
Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks
Time frame: 8 weeks
6 secondary outcomes
Urodynamic investigation
Time frame: 4 and 8 weeks
Standardised Pad test
Time frame: 4 and 8 weeks
Number of severe urinary stress incontinence episodes
Time frame: 4 and 8 weeks
Number of sanitary napkins used
Time frame: 4 and 8 weeks
Leakage index
Time frame: 4 and 8 weeks
Subjective appreciation of patients
Time frame: 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transvaginal electrical stimulation device in people with Urinary Stress Incontinence, run by Akontis at 1 site in France.
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 20 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: status not confirmed, as of the sponsor's last update on 17 Oct 2008. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks (time frame: 8 weeks). 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?
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 17 Oct 2008; AzTrials last refreshed its copy on 31 Oct 2026.