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Clinical Trials/CTRI/2023/11/060039
CTRI/2023/11/060039Not yet recruitingPhase 1

Effect of unsupervised pelvic floor muscle training on urodynamic profile among individuals with neurogenic bladder following spinal cord injury: A Pilot Randomized Controlled Trial

Shivani Shrikrishnavilas wattamwar1 site in 1 country20 target enrollmentStarted: November 27, 2023Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Urodynamics

Study Overview

Brief Summary

This study attempts to examine the effect of unsupervised pelvic floor muscle training among individuals with neurogenic bladder following spinal cord injury. ASIA Scale will be used as screening tool. Primary outcome is Urodynamic study in which pre and post intervention values will be compared among intervention and compatator groups. Secondary outcomes are neurogenic bladder symptom score(NBSS), Overactive bladder symptom score scale(OABSS) and bladder diary. Bladder diary will be maintained to record frequency, urgency. NBSS and OABSS will be assessed pre and post intervention and progression of urinary symptoms will be tracked. Pelvic floor muscle exercises will be taught to the intervention group along with standard care until they understand and able to perform and will be called to OPD if they face any problems. Follow up will be taken twice a week through phone calls. Comparator group will be taught standard care. All the outcomes will be assessed after 3 months of intervention. The data will be statistically analysed and result will be drawn.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Spinal cord injury patients with neurogenic bladder 2) Patients recovered from the spinal shock 3) Both male and female 4) Patients having ASIA score C or D.
  • Patient who are able to understand simple commands.

Exclusion Criteria

  • Neurogenic bladder associated with other neurological conditions.
  • Individuals having bladder dysfunction prior to spinal cord injury 3) Patients having other complications like urinary tract infection, hydronephrosis, kidney stones, etc.

Outcomes

Primary Outcomes

Urodynamics

Time Frame: 3 months

Secondary Outcomes

  • ASIA, Neurogenic bladder symptom score (NBSS) scale, overactive bladder symptom score (OABSS), Bladder Diary(3 months)

Investigators

Sponsor
Shivani Shrikrishnavilas wattamwar
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Shivani Shrikrishnavilas Wattamwar

MGM Institute of Physiotherapy

Study Sites (1)

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