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To study the effect of electrical pulses in reducing urinary leaks in patients with spinal cord injury

Posterior tibial nerve Vs Sham transcutaneous tibial nerve stimulation as neuromodulation therapy in treatment of detrusor overactivity in patients with spinal cord injury: A randomized control study - Restore Continence - RCT1

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077471
Enrollment
20
Registered
2024-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: G00-G99- Diseases of the nervous system Health Condition 2: S342- Injury of nerve root of lumbar andsacral spine Health Condition 3: S242- Injury of nerve root of thoracic spine

Interventions

Intervention1: POSTERIOR TIBIAL NERVE STIMULATION: surface electric transcutaneous posterior nerve stimulation for 30 mins twice daily for 14 consecutive days Control Intervention1: SHAM STIMULATION:

Sponsors

TIDE Division Department of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -age 18 years and above -Patient with spinal cord injury trojan having at least one leak per day(not stress leak) as reported in the voiding chart. -Clean intermittent catheterization -Presence of ankle jerk -CMG proven Detrusor overactivity

Exclusion criteria

Exclusion criteria: -Urinary Tract Infection -Peripheral Neuropathy -Pregnant Women -Psychiatric ailment -Symptoms of stress incontinence -Presence of implantable devices such as cochlear implant, pace makers, metallic implantable plates.

Design outcomes

Primary

MeasureTime frame
1. Reduction in number of leaks as observed by voiding diary 2. Increase in fluid intake as observed by voiding diary 3. Improvement in bladder capacity as observed by the voiding diaryTimepoint: Outcome 1,2 and 3 are to be monitored one week prior to the start of the stimulation and during the period of stimulation i.e. for 3 weeks everyday.

Secondary

MeasureTime frame
1. Reduction of maximum detrusor pressure as observed through Cystometrogram (CMG) 2. Improvement in cystometric capacity as observed by CMGTimepoint: Above secondary outcomes will be assessed on Day 1 and Day 15 i.e. Pre and Post Intervention

Countries

India

Contacts

Public ContactDr Jacob George

Department of Physical Medicine and Rehabilitation Christian Medical College

rajdeep@cmcvellore.ac.in04162205274

Outcome results

None listed

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