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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32312996

Enrollment

243

Registered

2010-03-25

Start date

2010-04-12

Completion date

Unknown

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence Urological and Genital Diseases Other disorders of urinary system

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany, Ireland, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026