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

Not Applicable

Completed

• Conditions: Overactive Bladder; Nocturia; Urge Incontinence
• Interventions: Other: Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening; Other: Pelvic floor muscles strengthening

• Registration Number: NCT05464589
• Lead Sponsor: Dow University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2022-04-09
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-19
• Primary Completion: 2022-07-25
• Study Completion: 2022-07-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous Tibial Nerve Stimulation + Pelvic Floor Muscle Strengthening	Transcutaneous tibial nerve stimulation along with pelvic floor muscle srengthening	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.
Pelvic Floor Muscle Strengthening	Pelvic floor muscles strengthening	Pelvic floor muscle strengthening through Kegel exercises. Pelvic floor muscle exercises - Kegels; exercises 15 repetitions, 3 times a day For 6 weeks, daily.

Primary Outcome Measures

Name	Time	Method
Change in Overactive Bladder Symptom Score from baseline at sixth week	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.

Trial Locations

Locations (3)

Dow University Hospital; 🇵🇰 Karachi, Sindh, Pakistan

Sindh Institute of Physical Medicine and Rehabilitation; 🇵🇰 Karachi, Sindh, Pakistan

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan