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

NCT06385769 | Not Yet Recruiting

• 1 other identifier: PamukkaleU.ftr-NYıldız-3
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Urinary Bladder, Overactive

Keywords

Overactive bladder after stroke; Transcutaneous tibial nerve stimulation; Urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Decreased frequency of increased voiding

  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 Outcomes (6)

• Frequency of voiding

  Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment

• The Quality of Life

  Change from baseline the Quality of Life at the 4th week after the treatment

• Barthel Index for Activities of Daily Living (ADL)

  Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment

• The Overactive Bladder Symptom Score (OABSS)

  Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment

• Treatment Satisfaction Level

  Change from baseline Treatment Satisfaction Level at the 4th week after the treatment

Study Arms (2)

Transcutaneous tibial nerve stimulation (TTNS)

EXPERIMENTAL

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)

Sham Transcutaneous tibial nerve stimulation (TTNS)

SHAM COMPARATOR

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)

Interventions

Transcutaneous tibial nerve stimulation (TTNS) OTHER

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.

Transcutaneous tibial nerve stimulation (TTNS)

Sham Transcutaneous tibial nerve stimulation (TTNS) OTHER

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.

Sham Transcutaneous tibial nerve stimulation (TTNS)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (20)

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MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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; Urination Disorders

Study Officials

• Necmettin Yıldız, Prof.

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Emre Bezmez, M.D.

CONTACT

+905319902220; emrebezmez@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: April 22, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)