Urinary incontinence Urological and Genital Diseases Other specified urinary incontinence
Conditions
Interventions
All women are supplied with the same magazine article outlining current self help treatment for urinary incontinence.
The women in the novel stimulation device group are supplied with enough single
Sponsors
Femeda Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: All women: 1. Who suffer from stress incontinence 2. Who self refer 3. Who are interested in participating in the study
Exclusion criteria
Exclusion criteria: 1. Age under 18 years or more than 65years 2. Lack of consent to stimulation 3. Pregnancy 4. Implanted pacemaker 5. Recent pelvic surgery (within last 3 months) 6. Recent haemmorhage / haematoma / tissue damage 7. Previous or at presently undergoing any active therapy for pelvic malignancy 8. Urinary tract infection 9. Vaginal infection 10. Atrophic vaginitis 11. Diabetes or neurological condition 12. Any lesions or other pathology of the vagina or labia 13. Manual dexterity insufficient to place the device 14. Previously had treatment for their urinary incontinence 15. Refusal to provide permission for general practitioner (GP) examination 16. GP determination that the patient is not suitable for participation in the investigation 17. Had baby within the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life measured at week 2, weeek 4 and week 12 through completion of the short form version of the International Consultation on Incontinence Questionnaire (ICIQ-UI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient Global Impression of Severity and of Improvement 2. Sexual dysfunction questionnaire (ICIQ-FLUTSex) 3. Diary of stimulation use and compliance Measured at week 2, weeek 4 and week 12 | — |
Countries
United Kingdom
Outcome results
None listed