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

NCT ID: NCT06247033

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-04-01

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.

Detailed Description

A sham-controlled double-blinded randomized study was undertaken. 28 patients with chronic stroke were randomized into 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.

In both groups, patients are followed for completing the standart schedule of PFTE and BT; and excluded from our study if their rates below %80 according to exercise and training schedule.

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.

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.

After 6 weeks, both groups were evaluated with urodynamic study for the second time.

ICIQ-SF, King's Health Questionaire, Overactive Bladder Syndrome Symptom Scoring and urodynamic study parameters were examined in both pre- and post-treatment period.

Results were compared to see if there is any difference in the patients who followed with TNS and also pre-post treatment symptoms with PFTE and BT.

Conditions

Incontinence, Urge; Stroke; Neurogenic Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Tibial Nerve Stimulation with TENS device

Intervention Type: 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.

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

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.

Group Type: SHAM_COMPARATOR

Pelvic muscle training exercise with bladder training

Intervention Type: 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.

Interventions

Tibial Nerve Stimulation with TENS 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.

Intervention Type: DEVICE

Pelvic muscle training exercise with bladder training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Umay Ekinci

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umay Ekinci, MD

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Department of PM&R

Locations

Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

42

Identifier Type: -

Identifier Source: org_study_id