Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01472068
Protocol/serial number
BMR-09-1008
Study information
Scientific title
A single-blind multicentre, controlled, randomised, blinded comparative study of three forms of pelvic floor muscle training: kegel exercises (KE), electrical stimulation using external skin-electrodes (ESEX) and electrical stimulation using an intra-vaginal electrode (ESIN), in the treatment of stress urinary incontinence
Acronym
INKO-OUTSIDE
Study hypothesis
Comparison of three forms of pelvic floor muscle training in the treatment of stress urinary incontinence:
1. Kegel exercises (KE)
2. Electrical stimulation using external skin-electrodes (ESEX)
3. Electrical stimulation using an intra-vaginal electrode (ESIN)
Ethics approval
Institutional Review Board (IRB) of North Georgia College & State University
Study design
Randomised controlled single blind multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stress urinary incontinence
Intervention
1. 12 weeks of treatment with Inko-Outside (external NMES) and 14 weeks of Kegels
2. 12 weeks of treatment with conventional NMES using an internal probe and 14 weeks of Kegels
3. 26 weeks of Kegels
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Change in continence scores compared to baseline:
1. Incontinence impact questionnaire score (IIQ-7)
2. Pelvic Floor Muscle strength as determined by Modified Oxford Scale upon digital palpation:
2.1. Pad usage
2.2. Leaks per week
2.3. Pad weight in provocative tests (cough and jumping jacks)
2.4. Compliance measure on stimulators and on diary for PFMT
3. Number of participants who have gone on to have surgery at 1 year - follow-up phone call
Secondary outcome measures
1. Proportion of group cured (namely, dry at each visit):
2. Proportion of group improved
3. Time to dryness in weeks
Dryness will be defined as dry for 5 consecutive days as reported by subjects on enquiry, and which is subsequently maintained until the end of the study (26 weeks). The status will also be confirmed by provocative tests with cough and jumping jack activities in the clinic. Participants having been declared "dry" will be determined to have relapsed if they have more than 1 leak per week, with normal activities.
Overall trial start date
12/04/2010
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Referrals with significant stress urinary incontinence (SUI) (defined as greater than 3 leaks/day or greater than 3 g in cough/jumping jack test) of any ethnic background
2. Pre-screened and cleared by gynaecological/urologist/suitably experienced PT for structural abnormalities (e.g. prolapsed uterus)
3. Body mass index (BMI) less than 40 kg/m^2
4. Non-smoker
5. Greater than 3 months post-partum
6. Females at least 18 and less than 70 years of age
7. Able to comply with either therapy
8. Able and willing to complete all of the study and provide informed written consent prior to entering the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
243
Participant exclusion criteria
1. Persons contra-indicated for ES
2. Individuals with a history of an underlying neurological condition
3. Individuals with an active implanted medical device, e.g., pacemaker or pump
4. Pregnant women or inadequate precautions to prevent pregnancy
5. Neurological impairment affecting pelvic floor musculature
6. Medication affecting continence
7. Medication for high blood pressure
8. Previous incontinence surgery, hysterectomy, previous gynaecological related surgery
9. Intra-uterine devices (IUDs) or metal implants in the pelvic area, including hip
10. Clinical diagnosis of prolapse
11. Abnormal Pap smear in the previous 6 months
Recruitment start date
12/04/2010
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Germany, Ireland, United Kingdom, United States of America
Trial participating centre
North Georgia College and State University
Dahlonega, Georgia
30597
United States of America
Sponsor information
Organisation
North Georgia College and State University (USA)
Sponsor details
c/o Dr Ruth Maher
Physical Therapy Department
82 College Circle
Dahlonega
Georgia
30597
United States of America
+1 706 864 1480
rmmaher@northgeorgia.edu
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Bio-Medical Research Ltd (UK) - provided devices
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary