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| [ Print-friendly version ] |
| Evaluation of a new technology to treat urinary incontinence in women |
| ISRCTN | ISRCTN74508432 |
| DOI | 10.1186/ISRCTN74508432 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Evaluation of a new technology to treat urinary incontinence in women |
| Scientific title | Evaluation of a new technology to treat urinary incontinence in women: a single blind randomised controlled trial |
| Acronym | FEMESTIM |
| Serial number at source | FEMESTIM CIP 002 |
| Study hypothesis | Null hypothesis: There will be no difference in outcome for women with urinary stress incontinence between those receiving standard written information about pelvic floor muscle exercises and those receiving this written information plus a novel electrical stimulation device (FEMESTIM) for restoring pelvic floor function. |
| Lay summary | Lay summary under review 1 |
| Ethics approval | North Sheffield Ethics Committee approved in January 2009, reference number 06/Q2308/134 |
| Study design | Single blind randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Urinary incontinence |
| Participants - inclusion criteria |
All women:
1. Who suffer from stress incontinence 2. Who self refer 3. Who are interested in participating in the study |
| Participants - 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 |
| Anticipated start date | 01/05/2009 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 200 |
| 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 use disposable electrodes to last them for twelve weeks of stimulation. Devices will be used for 30mins per day on a daily basis and switch on automatically on insertion into the vagina and switch off automatically after the 30mins time period after which time they are removed and discarded. Women in this group also receive an instruction leaflet regarding pelvic floor muscle exercises that should be undertaken during the course of the study. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | Femeda Ltd (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Jackie Oldham |
| Address |
Centre for Rehabilitation Science
University of Manchester Manchester Interdisciplinary Biocentre 131 Princess Street |
| City/town | Manchester |
| Zip/Postcode | M1 7DN |
| Country | United Kingdom |
| jackie.oldham@manchester.ac.uk | |
| Sponsor | Femeda Ltd (UK) |
| Address |
Westminster Business Centre
Lion Court Hanzard Drive Wynyard Business Park |
| City/town | Wynyard |
| Zip/Postcode | TS22 5FD |
| Country | United Kingdom |
| Sponsor website: | http://www.femeda.com |
| Date applied | 10/08/2011 |
| Last edited | 20/08/2012 |
| Date ISRCTN assigned | 20/09/2011 |
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| © 2013 ISRCTN unless otherwise stated. | |
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