Evaluation of a new technology to treat urinary incontinence in wome

Completed

• Conditions: rinary incontinence; Urological and Genital Diseases; Other specified urinary incontinence

• Registration Number: ISRCTN74508432
• Lead Sponsor: Femeda Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Patient Global Impression of Severity and of Improvement<br>2. Sexual dysfunction questionnaire (ICIQ-FLUTSex)<br>3. Diary of stimulation use and compliance<br>Measured at week 2, weeek 4 and week 12