Inko-Outside multicentre, controlled, randomised, blinded study for the treatment of stress urinary incontinence

ISRCTN	ISRCTN32312996
DOI	https://doi.org/10.1186/ISRCTN32312996
ClinicalTrials.gov number	NCT01472068
Secondary identifying numbers	BMR-09-1008

Submission date: 23/03/2010
Registration date: 25/03/2010
Last edited: 06/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ruth Maher
Scientific

North Georgia College and State University
82 College Circle
Dahlonega, Georgia
30597
United States of America

Study information

Study design	Randomised controlled single-blind multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	INKO-OUTSIDE
Study objectives	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(s)	Institutional Review Board (IRB) of North Georgia College & State University
Health condition(s) or problem(s) studied	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	Mixed
Primary outcome measure	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 study start date	12/04/2010
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	243
Key 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
Key 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
Date of first enrolment	12/04/2010
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

Germany
Ireland
United Kingdom
United States of America

Study participating centre

North Georgia College and State University

Dahlonega, Georgia
30597
United States of America

Sponsor information

North Georgia College and State University (USA)
University/education

c/o Dr Ruth Maher
Physical Therapy Department
82 College Circle
Dahlonega, Georgia
30597
United States of America

Phone	+1 706 864 1480
Email	rmmaher@northgeorgia.edu
Website	http://www.ngcsu.edu/
"ROR"	https://ror.org/001pe5g24

Funders

Funder type

Industry

Bio-Medical Research Ltd (UK) - provided devices

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

Editorial Notes

06/03/2019: No publications found, verifying study status with principal investigator.
08/04/2016: No publications found, verifying study status with principal investigator.