Evaluation of the Efficacy of Transcutaneous Tibial Nerve Stimulation on Post-Stroke Overactive Bladder

NCT06247033 | Completed

• 1 other identifier: 42
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to comparing the efficacies of different managements in patients with overactive bladder symptoms with stroke The main question it aims to answer are:

• Are pelvic floor training exercises and bladder training enough to ease the symptoms of overactive bladder in patients with stroke?
• Is tibial nerve stimulation really effective and does it decrease the need of medications in patients with overactive bladder with stroke? Participants are questioned if they have the symptoms of overactive bladder. After urodynamic evaluation, they are separated in 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks. Our main aim was to compare effectiveness of tibial nerve stimulation in patiens with overactive bladder with stroke.

Conditions

Incontinence, Urge; Stroke; Neurogenic Bladder

Outcome Measures

Primary Outcomes (2)

• Urodynamic Study Parameters

  Maximum Cystometric Capacity (mL)

  6 weeks

• Overactive Bladder Symptom Scoring

  A validated symptom scoring to detect the patients with overactive bladder symptoms and classifying them as low/moderate/high OABS. Higher results mean worse outcome

  6 weeks

Secondary Outcomes (2)

• ICIQ-SF

  6 weeks

• King's Health Questionaire

  6 weeks

Study Arms (2)

Active TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, TNS

ACTIVE COMPARATOR

Study group was followed with tibial nerve stimulation for 6 weeks, 2 sessions in a week, for 30 minutes. Stimulation was performed with TENS device, with settings of 10 Hz frequency, 200 msn wavelenght, continuous symetrical biphasic current. Amptlitude was increased just below the motor range that cause flexion in toes. All patiens were followed for PFTE and BT according to standard schedule.

Device: Tibial Nerve Stimulation with TENS device

Sham TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, Sham TNS

SHAM COMPARATOR

Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut down. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule.

Behavioral: Pelvic muscle training exercise with bladder training

Interventions

Tibial Nerve Stimulation with TENS device DEVICE

Tibial nerve stimulation was applied with TENS device transcutaneously and electrodes were positioned in medial part of the ankle. Negative transcutaneous electrode was positioned 3 centimeter posteriorly to the medial malleol. And positive transcutaneous electrode was positioned 10 centimeter above the negative electrode.

Active TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, TNS

Pelvic muscle training exercise with bladder training BEHAVIORAL

Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut off. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule.

Sham TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, Sham TNS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke patients who applied to our hospital with the illness interval of 6 months-24 months
• Cooperated patients with mini mental test 18 and above
• Patients who willing to be a participant
• Patients with scoring of OABSS 3 and above (at least 2 points must be gained from question 3.) will be evaluated with urodynamic study and only the patients with overactive detrusor findings during urodynamic study will be included.

You may not qualify if:

• Patients who not willing to be a participant
• Psychiatric or cognitive impairment, MMT \< 18
• Spasticity that effects whole body, MAS 3 and above
• Urinary symptoms before stroke
• Global or sensorial aphasia
• Cardiac pacemaker
• Urinary tract infection
• Benign prostate hypertrophy
• Already receiving any treatment because of neurogenic bladder
• History of botulinum toxin injection to the detrusor muscle
• Active malignancy
• Pregnants
• Post-void residue above 200 mL

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Stroke; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Urinary Bladder Diseases

Study Officials

• Umay Ekinci, MD

  University of Health Sciences, Department of PM&R

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 7, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)