Evaluation of a new technology to treat urinary incontinence in women
| ISRCTN | ISRCTN74508432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74508432 |
| Secondary identifying numbers | FEMESTIM CIP 002 |
- Submission date
- 10/08/2011
- Registration date
- 20/09/2011
- Last edited
- 31/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study has been designed to test a new device for the treatment of incontinence in women and to compare it with information on self managing the problem provided by the Continence Foundation. This new device has been developed by Femeda (a UK company producing products for the treatment of incontinence) and scientists at the University of Manchester.
This is an electrical stimulation device designed to stimulate the pelvic floor muscles. The device is similar in size and shape to a tampon, is comfortable to use and is inserted into the vagina using a plastic inserter. The device switches off automatically after 30 minutes. At this stage it can be removed and thrown away. This is the first time a disposable device has been tested on women, although the stimulation technology has previously been tested on women using a non-disposable device.
Who can participate?
200 women have been recruited to take part in this study. They are aged between 18 and 65 years and suffer from urinary incontinence, but are otherwise healthy.
What does the study involve?
The study is 18 weeks long and involves four (30-40 minute) visits at a specialist research centre in Manchester - the Wellcome Trust Clinical Research Facility (WTCRF). During the first visit a video is shown that describes the project in detail. Women are then given an opportunity to discuss the study and if agree to take part, sign a consent form. A physical examination is then undertaken by a qualified doctor. This involves palpation of the stomach and a vaginal examination to check for any infections or abnormalities. A sample of urine is also collected. Each woman then keeps a diary sheet to record any incontinent episodes for one week on four occasions throughout the study. The second visit is one week after the first. During this visit each woman fills in three questionnaires about the effects of incontinence on quality of life and on sex life. Each woman then receives information on managing incontinence which has been produced by the Continence Foundation.
Four weeks later everyone returns to the Research Facility for a third visit and fills out the questionnaires again. The women are then randomly assigned to one of two groups. One group receives the electrical stimulation device and the other group continues to manage their incontinence according to the recommendations from the Continence Foundation. Those getting the device are asked to use this for 30 minutes per day for 12 weeks, except during a menstrual period. At the end of the 12 weeks the fourth visit takes place when the questionnaires about quality of life and sexual dysfunction are completed for the final time.
What are the possible benefits and risks of participating?
We are not aware of any additional risks or side effects though some women may find it a little inconvenient to use the device for 30 minutes per day. However, it can be used whilst carrying out normal activities, as for tampons, so we do not envisage too much inconvenience. We hope that the electrical stimulation device will have a great potential benefit in terms of improving symptoms of incontinence. The electrical stimulation device will be further developed until early 2012 and we envisage it will then be manufactured for sale in chemists and supermarkets to be freely available to all women. We hope it will be available in the UK in 2012-2013.
Where is the study run from?
The Wellcome Trust Clinical Research Facility (WTCRF), Manchester, UK.
When is the study starting and how long is it expected to run for?
The study started in May 2009 and is expected to run until the end of 2011.
Who is funding and overseeing the study?
Femeda the company producing the device.
Who is the main contact?
Professor Jackie Oldham
jackie.oldham@manchester.ac.uk
Contact information
Scientific
Centre for Rehabilitation Science
University of Manchester
Manchester Interdisciplinary Biocentre
131 Princess Street
Manchester
M1 7DN
United Kingdom
| jackie.oldham@manchester.ac.uk |
Study information
| Study design | Single blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of a new technology to treat urinary incontinence in women: a single blind randomised controlled trial |
| Study acronym | FEMESTIM |
| Study objectives | 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. |
| Ethics approval(s) | North Sheffield Ethics Committee approved in January 2009, reference number 06/Q2308/134 |
| Health condition(s) or problem(s) studied | Urinary incontinence |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 01/05/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | All women: 1. Who suffer from stress incontinence 2. Who self refer 3. Who are interested in participating in the study |
| Key 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 |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M1 7DN
United Kingdom
Sponsor information
Industry
Westminster Business Centre
Lion Court
Hanzard Drive
Wynyard Business Park
Wynyard
TS22 5FD
United Kingdom
| Website | http://www.femeda.com |
|---|---|
"ROR" |
https://ror.org/02c19c733 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
