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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nocturia Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Signs and Symptoms Urge Incontinence Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University Hospital, Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening

Other

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.

Pelvic floor muscles strengthening

Other

Pelvic floor muscles strengthening:

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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 19, 2022
Registry last updated: Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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