Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.

Summary

This study aims to evaluate the use of transcutaneous tibial nerve stimulation (TTNS) and parasacral nerve stimulation (PSS) methods in the treatment of overactive bladder (OAB) symptoms in patients with Multiple Sclerosis (MS), including urination frequency, urgency, urinary incontinence, post-void residue, maximum micturition rate. To investigate the effect on parameters such as voiding volume and quality of life and to compare the final results between groups.

Conditions

• Multiple Sclerosis
• Overactive Bladder Syndrome

Interventions

DEVICE

TTNS (Transcutaneous tibial nerve stimulation)

Electrodes will be placed in two areas simultaneously (posterior tibial nerve and parasacral locations). Only the electrodes going to the tibial region will be activated, the parasacral electrodes will not be active. A Biolito (MTR+Vertriebs GmbH, Berlin) stimulator will be used to perform posterior tibial nerve stimulation. Stimulation will be delivered via two 50 mm x 50 mm adhesive electrode pads under the left medial malleolus and 5 cm proximal to the distal electrode. Appropriate electrode site will be confirmed by the presence of big toe plantar flexion during stimulation (stimulus intensity will be adjusted according to the patient's tolerance for 200 μs duration at 10 Hz frequency). Stimulation will be applied 2 days a week, each application for 30 minutes, for 6 weeks.

DEVICE

PNS (Parasacral nerve stimulation)

Electrodes will be placed in two areas simultaneously (posterior tibial nerve and parasacral locations). Only the electrodes going to the parasacral region will be activated, the tibial electrodes will not be active. For parasacral region stimulation, electrodes will be positioned symmetrically in the parasacral region under the posterior superior iliac spines to stimulate the S2 and S3 nerve roots. A duration of 200 μs at a frequency of 10 Hz will be set with the Biolito (MTR+Vertriebs GmbH, Berlin) stimulator. The intensity level will be adjusted according to the tolerance of the patient. Stimulation will be applied 2 days a week, each application for 30 minutes, for 6 weeks.

DEVICE

Sham stimulation

Electrodes will be placed in three areas simultaneously. These regions are the tibial and parasacral locations and the scapular region, with a distance of approximately 4 cm between the electrodes. Of these three regions, only the channel to the scapular region will be activated, the remaining two regions will be closed. Regarding the sham group, the parameters used in the scapular region will be applied with a frequency of 100 Hz, a pulse duration of 100 μs, and 30 minutes. This configuration is known as conventional transcutaneous electrical nerve stimulation and is commonly used for non-invasive and non-pharmacological treatment of pain.Stimulation will be applied 2 days a week, each application for 30 minutes, for 6 weeks.

BEHAVIORAL

Behavioral treatment

It includes techniques and skills to prevent incontinence and restrain the urge to urinate. It also includes lifestyle interventions such as losing weight, relieving constipation, quitting smoking, reducing caffeine, managing uric acid, wearing non-restrictive, easily removable clothing, reducing emotional stress, and correcting faulty frequent urination by introducing avoidance and distraction techniques. Additionally, advice on proper voiding position and an exercise protocol will be given. The exercise protocol will include three sets of 8-10 near-maximal contractions in lying, sitting and standing positions. Each contraction will be based on the endurance of the pelvic floor muscles and the participant will aim to hold the muscles for 10 seconds. They will be told to do it twice a day, morning and evening. Participants will perform the behavioral training protocol at home.

Sponsors & Collaborators

• Marmara University

  collaborator OTHER

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-20

Primary Completion

2025-10-20

Completion

2025-10-30

Countries

• Turkey (Türkiye)

Study Locations