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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

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

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Device: transvaginal placebo device Device: transvaginal electrical stimulation device Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Study Start Date : January 2006
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
transvaginal electrical stimulation with a 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

Placebo Comparator: 2
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
Device: transvaginal placebo device
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks




Primary Outcome Measures :
  1. Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks [ Time Frame: 8 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. Urodynamic investigation [ Time Frame: 4 and 8 weeks ]
  2. Standardised Pad test [ Time Frame: 4 and 8 weeks ]
  3. Number of severe urinary stress incontinence episodes [ Time Frame: 4 and 8 weeks ]
  4. Number of sanitary napkins used [ Time Frame: 4 and 8 weeks ]
  5. Leakage index [ Time Frame: 4 and 8 weeks ]
  6. Subjective appreciation of patients [ Time Frame: 4 and 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762593


Locations
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France
Centre européen d'explorations gynécologiques
Paris, France, 75005
Sponsors and Collaborators
Akontis
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Responsible Party: Jacques Croissandeau, Akontis
ClinicalTrials.gov Identifier: NCT00762593    
Other Study ID Numbers: KEAT F1
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008
Keywords provided by Akontis:
urinary stress incontinence
urinary stress incontinence in women
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations