Condition category
Urological and Genital Diseases
Date applied
23/03/2010
Date assigned
25/03/2010
Last edited
08/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ruth Maher

ORCID ID

Contact details

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

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

http://www.ngcsu.edu/

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

Publication citations

Additional files

Editorial Notes

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