Effects of Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Symptoms in Adults

April 21, 2023 updated by: Sana Subhan, Dow University of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences
      • Karachi, Sindh, Pakistan
        • Dow University Hospital
      • Karachi, Sindh, Pakistan
        • Sindh Institute of Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • Patients receiving any treatment other than the prescribed medications by the referring physician (that will be the same for all patients of both groups) will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening

Pelvic floor muscle strengthening through Kegel exercises along with the transcutaneous tibial nerve stimulation.

Pelvic Floor Muscle-strengthening exercises - Kegels' exercises 15 repetitions, 3 times a day For 6 weeks, daily.

Transcutaneous Tibial Nerve Stimulation for 30 minutes on the right lower limb 6 sessions, one per week.
Other: Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening

Pelvic floor muscles strengthening:

Pelvic floor muscles training involves Kegel's exercises. Kegel exercises improve the function and tone of the pelvic floor. Kegel exercises represent the voluntary contraction and relaxation of the levator ani muscle (principally the pubococcygeus and puborectalis portions), which supports the vagina, bladder, and urethra. The slow contractions help with muscle strengthening.

Transcutaneous electrical stimulation of Tibial Nerve:

Transcutaneous Tibial nerve stimulation is a form of treatment technique that involves the use of electrical impulses to address urinary symptoms and target the lower urinary tract.
Active Comparator: Pelvic Floor Muscle Strengthening

Pelvic floor muscle strengthening through Kegel exercises.

Pelvic floor muscle exercises - Kegels; exercises 15 repetitions, 3 times a day For 6 weeks, daily.
Other: Pelvic floor muscles strengthening

Pelvic floor muscles strengthening:

Pelvic floor muscles training involves Kegel's exercises. Kegel exercises improve the function and tone of the pelvic floor. Kegel exercises represent the voluntary contraction and relaxation of the levator ani muscle (principally the pubococcygeus and puborectalis portions), which supports the vagina, bladder, and urethra. The slow contractions help with muscle strengthening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Sana Subhan, DPT, Dow University of Health Sciences
  • Study Director: Dr. Syed Imran Ahmed, MBBS, FCPS, Sindh Institute of Physical Medicine and Rehabilitation
  • Study Director: Dr. Muhammad Hammad Mithani, MBBS, FCPS, Dow University Hospital
  • Study Director: Aftab Ahmed Mirza Baig, DPT, MSAPT, Sinsh Institute of Physical Medicine and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2021

Primary Completion (Actual)

July 25, 2022

Study Completion (Actual)

July 25, 2022

Study Registration Dates

First Submitted

April 9, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSubhan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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