Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke

April 25, 2024 updated by: Necmettin Yildiz, Pamukkale University

Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke: A Randomized Placebo-controlled Clinical Trial.

The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.

The main questions aimed to be answered are:

What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 40 and above with stable ischemic or hemorrhagic stroke.
  • Patients with neurogenic detrusor overactivity symptoms accompanied by urinary incontinence complaints and a urinary frequency of 9 or more.
  • Patients diagnosed with detrusor overactivity on urodynamic evaluation.
  • Patients with hemiplegia lasting between 30 days and 1 year.
  • Ability to understand procedures, benefits, and potential side effects.
  • Patients scoring 22 or above on the Mini Mental Test.

Exclusion Criteria:

  • Patients with post-stroke neurogenic detrusor overactivity receiving or previously received pharmacological treatment.
  • Patients using intermittent catheterization or permanent catheterization as a bladder emptying method.
  • Patients with a history of urinary incontinence and/or urinary retention before stroke.
  • History of past urogynecological surgery.
  • Presence of urinary tract infection, bladder tumor, or cardiac pacemaker.
  • Significant fluid infusion requirement affecting urination or use of medication affecting bladder function.
  • Patients who have received botulinum toxin injection for post-stroke neurogenic detrusor overactivity.
  • Patients with postvoid residual volume above 150 mL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous tibial nerve stimulation (TTNS)
In this study, one channel of the stimulation device will provide active stimulation to the patient, while the second channel will not be connected. The patient won't know which channel is active. Both channels will use continuous mode with a pulse frequency of 20 Hz and a pulse width of 200 ms. The intensity for the active channel will be adjusted based on comfort level and observed hallux reaction. Treatment includes 20 sessions of 30 minutes each, administered five times a week for four weeks.
Other: Transcutaneous tibial nerve stimulation (TTNS)
The TTNS will be conducted unilaterally, with the patient in a supine position, using a surface electrode dual stimulation channel stimulation device. Two self-adhesive round surface electrodes will be positioned with the negative electrode 2 cm behind the medial malleolus and the positive electrode 10 cm proximal to it. The ground electrode will be placed on the ipsilateral limb. Channel 1 will provide active stimulation, while channel 2 will remain inactive.
Sham Comparator: Sham Transcutaneous tibial nerve stimulation (TTNS)
In the placebo group, the same electrotherapy device and settings as the active group will be used. One channel will not be connected to the patient but will display treatment details on the screen. The other channel will be connected but deliver no stimulation. Intensity for the inactive channel is limited to 2-3 mA. Patients will be informed that exceeding this threshold is prevented. Treatment includes 20 sessions of 30 minutes each, administered twice a week for four weeks.
Other: Sham Transcutaneous tibial nerve stimulation (TTNS)
Sham TTNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the TTNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased frequency of increased voiding
Time Frame: Change from baseline positive response rate at the 4th week after the treatment
The effectiveness of the treatment is evaluated based on the daily voiding frequency post-treatment compared to the daily voiding frequency pre-treatment. The expected outcome is a reduction in the frequency of increased voiding.
Change from baseline positive response rate at the 4th week after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of voiding
Time Frame: Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment
The frequency of voiding used will be calculated from the patient's 3-day voiding frequency.
Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment
The Quality of Life
Time Frame: Change from baseline the Quality of Life at the 4th week after the treatment
The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence
Change from baseline the Quality of Life at the 4th week after the treatment
Barthel Index for Activities of Daily Living (ADL)
Time Frame: Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment
The Barthel Index assesses activities of daily living (ADLs), documenting what a patient does daily without determining capabilities. The 10 items to score are: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation, and stair climbing. Scores reflect independence, with lower scores indicating less independence. A score above 60 typically denotes independence.
Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment
The Overactive Bladder Symptom Score (OABSS)
Time Frame: Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment
OABSS (Overactive Bladder Symptom Score), four questions assessing daytime frequency (OABSS-1), nocturia frequency (OABSS-2), urgency frequency (OABSS-3), and urgency urinary incontinence (OABSS-4). Severity is rated on a Likert scale from 0-2, 0-3, 0-5, and 0-5, respectively. The total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment
Treatment Satisfaction Level
Time Frame: Change from baseline Treatment Satisfaction Level at the 4th week after the treatment
At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied).
Change from baseline Treatment Satisfaction Level at the 4th week after the treatment
Cystometric value
Time Frame: Change from baseline Cystometric value at the 4th week after the treatment
Cystometric value are useful in defining the voiding characteristics of patients.
Change from baseline Cystometric value at the 4th week after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Director: Necmettin Yıldız, Prof., Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 22, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PamukkaleU.ftr-NYıldız-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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