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Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence (KEAT F1)

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ClinicalTrials.gov Identifier: NCT00762593
Recruitment Status : Unknown
Verified October 2008 by Akontis.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
Akontis

Tracking Information
First Submitted Date  ICMJE September 29, 2008
First Posted Date  ICMJE September 30, 2008
Last Update Posted Date October 17, 2008
Study Start Date  ICMJE January 2006
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Official Title  ICMJE A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urinary Stress Incontinence
Intervention  ICMJE
  • Device: transvaginal placebo device
    Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
  • Device: transvaginal electrical stimulation device
    Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
Study Arms  ICMJE
  • Experimental: 1
    transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks
    Intervention: Device: transvaginal electrical stimulation device
  • Placebo Comparator: 2
    Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
    Intervention: Device: transvaginal placebo device
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
150
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2008
Estimated Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >=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
  • 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)

Exclusion Criteria:

  • 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
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762593
Other Study ID Numbers  ICMJE KEAT F1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacques Croissandeau, Akontis
Study Sponsor  ICMJE Akontis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Akontis
Verification Date October 2008

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