Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.
NCT ID: NCT06143397
Last Updated: 2025-12-04
Study Results
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Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2023-11-20
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TTNS (Transcutaneous tibial nerve stimulation)
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.
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.
PNS (Parasacral nerve stimulation)
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.
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.
Sham stimulation
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 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.
Interventions
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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.
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.
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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
65 Years
FEMALE
No
Sponsors
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Marmara University
OTHER
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
OTHER
Responsible Party
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Busra Aydin Erkilic
Physiotherapist
Locations
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Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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Neurogenic Bladder
Identifier Type: -
Identifier Source: org_study_id
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