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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??

â??A Randomized Control Trial To Compare Effectiveness Of Electrical Stimulation Of Foot And Oxybutynin In Overactive Bladder In Persons With Spinal Cord Injuryâ??

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013735
Enrollment
30
Registered
2018-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: S241- Other and unspecified injuries ofthoracic spinal cord Health Condition 2: null- Spinal Cord Injury

Interventions

Intervention1: Electrical Stimulation of foot: Site- Two self adhesive electrodes will be applied over sole of foot. Cathode will be placed proximal to anode. Schedule- Five days a week, excluding Sat

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Quality of life by IQOL questionnaire. Change in voiding diary (number of daytime/nocturnal leakages/leakage volume) in patients of clean intermittent catheterization / self voiding Change in bladder capacity or voiding volume by clean intermittent catheterization / self voiding Timepoint: Day 0 and Day14

Secondary

MeasureTime frame
Volume at first involuntary detrusor contraction by single channel cystometry Change in maximum pressure by single channel cystometry Timepoint: Day 0 and Day 14

Countries

India

Contacts

Public ContactSamantak Sahu

AIIMS, New Delhi

srikumar.venkataraman@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026