â??A Study To Compare Effectiveness Of Electrical Stimulation Of Foot And Oxybutynin-a common medication in frequent uncontrolled urination In Persons With Spinal Cord Injuryâ??
Phase 2
- Conditions
- Health Condition 1: S241- Other and unspecified injuries ofthoracic spinal cordHealth Condition 2: null- Spinal Cord Injury
- Registration Number
- CTRI/2018/05/013735
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Traumatic and non-traumatic Spinal Cord Injury
Overactive Bladder (Detrusor hypereflexia) with urinary incontinence
No oral therapy to inhibit Neurogenic Overactive Bladder within one week
No botulinum toxin injection to detrusor within one year.
Informed consent
Exclusion Criteria
Pregnancy
Urinary tract infection as defined by American Paraplegia Society
Urinary calculus
Urinary tumor
Cardiac permanent pacemaker
Epilepsy
Local pathology of foot like frail skin, ulcer, infection etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life by IQOL questionnaire. <br/ ><br>Change in voiding diary (number of daytime/nocturnal leakages/leakage volume) in patients of clean intermittent catheterization / self voiding <br/ ><br>Change in bladder capacity or voiding volume by clean intermittent catheterization / self voiding <br/ ><br>Timepoint: Day 0 and Day14 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Volume at first involuntary detrusor contraction by single channel cystometry <br/ ><br>Change in maximum pressure by single channel cystometry <br/ ><br>Timepoint: Day 0 and Day 14