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Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Urinary Incontinence

Treatments

Device: KEAT stimulator

Study type

Observational

Funder types

Other

Identifiers

NCT01276340
1008433

Details and patient eligibility

About

The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.

Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.

Enrollment

450 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • women
  • age > 18 years
  • stress, urge or mixed incontinence with indication of perineal reeducation
  • follow in gynecology

Exclusion criteria

  • incontinence due to neurological disorders
  • younger than 18 years old
  • pregnancy
  • patient with pace-maker
  • patient with gynecological cancer
  • patient who don't understand the electrical stimulation procedure

Trial design

450 participants in 1 patient group

1
Description:
women with urinary incontinence
Treatment:
Device: KEAT stimulator

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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