Inko-Outside multicentre, controlled, randomised, blinded study for the treatment of stress urinary incontinence
- Conditions
- Stress urinary incontinenceUrological and Genital DiseasesOther disorders of urinary system
- Registration Number
- ISRCTN32312996
- Lead Sponsor
- orth Georgia College and State University (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 243
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Change in continence scores compared to baseline:<br> 1. Incontinence impact questionnaire score (IIQ-7)<br> 2. Pelvic Floor Muscle strength as determined by Modified Oxford Scale upon digital palpation:<br> 2.1. Pad usage<br> 2.2. Leaks per week<br> 2.3. Pad weight in provocative tests (cough and jumping jacks)<br> 2.4. Compliance measure on stimulators and on diary for PFMT<br> 3. Number of participants who have gone on to have surgery at 1 year - follow-up phone call<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Proportion of group cured (namely, dry at each visit):<br> 2. Proportion of group improved<br> 3. Time to dryness in weeks<br><br> 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.<br>