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

Primary Purpose

Urinary Stress Incontinence

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
transvaginal placebo device
transvaginal electrical stimulation device
Sponsored by
Akontis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring urinary stress incontinence, urinary stress incontinence in women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre européen d'explorations gynécologiques

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks

Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks

Outcomes

Primary Outcome Measures

Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 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

Secondary Outcome Measures

Urodynamic investigation
Standardised Pad test
Number of severe urinary stress incontinence episodes
Number of sanitary napkins used
Leakage index
Subjective appreciation of patients

Full Information

First Posted
September 29, 2008
Last Updated
October 16, 2008
Sponsor
Akontis
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1. Study Identification

Unique Protocol Identification Number
NCT00762593
Brief Title
Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Acronym
KEAT F1
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Akontis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
urinary stress incontinence, urinary stress incontinence in women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
Intervention Type
Device
Intervention Name(s)
transvaginal placebo device
Intervention Description
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
Intervention Type
Device
Intervention Name(s)
transvaginal electrical stimulation device
Intervention Description
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
Primary Outcome Measure Information:
Title
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
Time Frame
8 weeks
Title
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 Measure Information:
Title
Urodynamic investigation
Time Frame
4 and 8 weeks
Title
Standardised Pad test
Time Frame
4 and 8 weeks
Title
Number of severe urinary stress incontinence episodes
Time Frame
4 and 8 weeks
Title
Number of sanitary napkins used
Time Frame
4 and 8 weeks
Title
Leakage index
Time Frame
4 and 8 weeks
Title
Subjective appreciation of patients
Time Frame
4 and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Centre européen d'explorations gynécologiques
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

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Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence

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