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Clinical Trials/NCT05464589
NCT05464589
Completed
Not Applicable

Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults: A Randomized Control Trial

Dow University of Health Sciences3 sites in 1 country60 target enrollmentAugust 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Dow University of Health Sciences
Enrollment
60
Locations
3
Primary Endpoint
Change in Overactive Bladder Symptom Score from baseline at sixth week
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

For overactive bladder symptoms, there are numerous physiotherapy techniques have been found to be beneficial. Transcutaneous electrical stimulation of the tibial nerve is one of those treatment options, that is entirely a non-invasive, easy to apply, and cost-effective technique.

Transcutaneous stimulation of the tibial nerve targets the sacral nerve plexus that contracts the pelvic floor muscles and controls the bladder function.

This research aims to study the effectiveness of transcutaneous tibial nerve stimulation in adults with overactive bladder symptoms along with the conventional physiotherapy for overactive bladder (pelvic floor muscle training through Kegel's exercises) among 60 patients with overactive bladder symptoms on the basis of non-probability purposive sampling technique with screening for study criteria through a consultant urologist. After taking informed consent, all participants will be randomly allocated into two groups. Group A will receive pelvic floor muscles training through Kegels exercises along with transcutaneous electrical stimulation of the tibial nerve and Group B will receive pelvic floor muscles training through Kegels exercises. The treatment duration will of six weeks. Outcomes will be assessed before the start of the treatment and after the end of the treatment sessions.

Registry
clinicaltrials.gov
Start Date
August 10, 2021
End Date
July 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sana Subhan

Principal Investigator

Dow University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Clinically diagnosed overactive bladder
  • A total OABSS score of 3 or more and an urgency score of 2 or more
  • 30-65 years old

Exclusion Criteria

  • Pregnancy
  • Acute urinary tract infection (within 15 days)
  • Any surgical procedure for urinary incontinence
  • Genito-urinary cancer history
  • Stage II pelvic organ prolapse according to pelvic organ prolapse-quantification system
  • Lesion on the site of stimulation or around it
  • Pelvic pacemakers
  • Lower limbs prostheses
  • Patients who will not be able to perform Kegel's exercises
  • An impaired sensation at the site of stimulation.

Outcomes

Primary Outcomes

Change in Overactive Bladder Symptom Score from baseline at sixth week

Time Frame: At baseline and after 6 weeks

OABSS is a validated instrument which evaluates the four cardinal symptoms (day and nighttime frequency, urgency, and urge incontinence) of OAB in a one score. A total OABSS score of 3 or more and an urgency score of 2 or more is the recommended cut-off for diagnosing OAB, and the severity is further divided into mild (total score of 3-5 points), moderate (6-11 points) and severe (12 or more points). Patients will be evaluated at baseline and 6 weeks after the intervention through OABSS.

Study Sites (3)

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