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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overactive Bladder, Urge Incontinence, Nocturia

Intervention / Treatment
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* Other: Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening
* Other: Pelvic floor muscles strengthening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a randomized control trial. Total 60 patients will be recruited, 30 in each group. Treatment will be allocated using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening<br>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<br>* 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.<br>|
| Active Comparator: Pelvic Floor Muscle Strengthening<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overactive Bladder Symptom Score from baseline at sixth week | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower urinary tract symptoms (LUTS), urge incontinence, overactive detrusor, neuromodulation therapy, nocturia, pelvic floor disease