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

NCT06143397 | Completed DMC

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

Brief 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

Outcome Measures

Primary Outcomes (4)

• Uroflowmetry

  It provides a valuable non-invasive assessment of voiding functions. It is the measurement of urine flow rate in ml/sec with the help of a flow meter. Since it is non-invasive among urodynamic tests, it can be used for screening purposes. Pattern and rate of flow depend on detrusor function and bladder outlet resistance.

  Baseline

• Uroflowmetry

  It provides a valuable non-invasive assessment of voiding functions. It is the measurement of urine flow rate in ml/sec with the help of a flow meter. Since it is non-invasive among urodynamic tests, it can be used for screening purposes. Pattern and rate of flow depend on detrusor function and bladder outlet resistance.

  After the 6-week intervention

• Post voiding residue (PVR)

  PVR will be measured using a 5-13-MHz convex ultrasound probe.

  Baseline

• Post voiding residue (PVR)

  PVR will be measured using a 5-13-MHz convex ultrasound probe.

  After the 6-week intervention

Secondary Outcomes (10)

• Overactive bladder form (OAB-v8)

  Baseline

• Three-day bladder diary (BD)

  Baseline

• King's Quality of Life Questionnaire (KHQ)

  Baseline

• Incontinence Severity Index (ISI)

  Baseline

• Neurogenic Bladder Symptom Score (NBSS)

  Baseline

Study Arms (3)

TTNS (Transcutaneous tibial nerve stimulation)

EXPERIMENTAL

Device: TTNS (Transcutaneous tibial nerve stimulation); Behavioral: Behavioral treatment

PNS (Parasacral nerve stimulation)

EXPERIMENTAL

Device: PNS (Parasacral nerve stimulation); Behavioral: Behavioral treatment

Sham stimulation

SHAM COMPARATOR

Device: Sham stimulation; Behavioral: Behavioral treatment

Interventions

PNS (Parasacral nerve stimulation) DEVICE

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.

PNS (Parasacral nerve stimulation)

Sham stimulation DEVICE

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.

Sham stimulation

Behavioral treatment BEHAVIORAL

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.

PNS (Parasacral nerve stimulation); Sham stimulation; TTNS (Transcutaneous tibial nerve stimulation)

TTNS (Transcutaneous tibial nerve stimulation) DEVICE

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.

TTNS (Transcutaneous tibial nerve stimulation)

Eligibility Criteria

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

You may qualify if:

• Having symptoms related to overactive bladder (OAB-v8 score ⩾8),
• Over 18 years of age
• No relapse for at least 1 month
• All types of MS, including those with relapses
• Female MS patients with an Expanded Disability Status Scale (EDSS) score below 7.0
• Agreeing to participate in the research

You may not qualify if:

• Patients with urinary tract infections
• Patients diagnosed with diabetes mellitus
• Patients using diuretic drugs or patients with a clean intermittent catheter
• Patients with a history of different urological diseases
• Patients with heart or brain pacemaker users, those with epilepsy, and patients with language and cognitive limitations
• Patients who are pregnant or in the postpartum period
• Lack of activity performance for 2 weeks (regardless of which group)

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead
• Marmara University: collaborator

Study Sites (1)

Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Marzouk MH, Darwish MH, El-Tamawy MS, Morsy S, Abbas RL, Ali AS. Posterior tibial nerve stimulation as a neuromodulation therapy in treatment of neurogenic overactive bladder in multiple sclerosis: A prospective randomized controlled study. Mult Scler Relat Disord. 2022 Dec;68:104252. doi: 10.1016/j.msard.2022.104252. Epub 2022 Oct 17.

  PMID: 36274285 BACKGROUND

• Jacomo RH, Alves AT, Lucio A, Garcia PA, Lorena DCR, de Sousa JB. Transcutaneous tibial nerve stimulation versus parasacral stimulation in the treatment of overactive bladder in elderly people: a triple-blinded randomized controlled trial. Clinics (Sao Paulo). 2020 Jan 10;75:e1477. doi: 10.6061/clinics/2020/e1477. eCollection 2020.

  PMID: 31939564 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: November 20, 2023
• Primary Completion: October 20, 2025
• Study Completion: October 30, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)