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Multiple SclerosisNCT06143397

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

A study testing TTNS (Transcutaneous tibial nerve stimulation), PNS (Parasacral nerve stimulation) and Behavioral treatment in people with Multiple Sclerosis and Overactive Bladder Syndrome, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
TTNS (Transcutaneous tibial nerve stimulation), PNS (Parasacral nerve stimulation) and Behavioral treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Nov 2023to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Transcutaneous Posterior Tibial Nerve Stimulation and Parasacral Transcutaneous Electrical Stimulation on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.

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.

Read the detailed description

Participants will be divided into 3 groups: TTNS, PNS, and placebo groups, and all participants will be given behavioral treatment. Tibial nerve stimulation will be given to the TTNS group, sacral nerve stimulation will be given to the PNS group, and sham current will be given to the placebo group. Stimulation treatments will be applied 2 days a week for 30 minutes each for 6 weeks. Participants will be evaluated before and after treatment. The parameters of urination frequency, urgency, and urinary incontinence will be evaluated with a 3-day voiding diary (BD), maximum flow rate (Qmax), time to reach maximum flow (TQmax), average flow rate, flow time (Tw), voiding time and voiding volume (VV) values will be evaluated by uroflowmetry, post-voiding residual (PVR) volume will be evaluated by ultrasound, and quality of life will be evaluated by King's Quality of Life Questionnaire (KHQ); Expanded Disability Status Scale (EDSS), Overactive bladder form (OAB-v8), Incontinence Severity Index (ISI), Neurogenic Bladder Symptom Score (NBSS) will be recorded.

Being tested
TTNS (Transcutaneous tibial nerve stimulation), PNS (Parasacral nerve stimulation), Sham stimulation, Behavioral treatment
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • Sham stimulationDevice

    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 treatmentBehavioural

    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.

Study groups in NCT06143397
Study groupRoleWhat they receive
TTNS (Transcutaneous tibial nerve stimulation)ExperimentalNot described
Receives: Device: TTNS (Transcutaneous tibial nerve stimulation); Behavioral: Behavioral treatment
PNS (Parasacral nerve stimulation)ExperimentalNot described
Receives: Device: PNS (Parasacral nerve stimulation); Behavioral: Behavioral treatment
Sham stimulationSham comparatorNot described
Receives: Device: Sham stimulation; Behavioral: Behavioral treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: After the 6-week intervention

  3. Post voiding residue (PVR)

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

    Measured: Baseline

  4. Post voiding residue (PVR)

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

    Measured: After the 6-week intervention

Secondary outcomes (10)
  1. Overactive bladder form (OAB-v8)

    OAB-v8 is an eight-item screening test for overactive bladder (OAB) symptoms and has been validated in Turkish. The total score is between 0 and 40. Higher scores indicate OAB symptom burden and severity.

    Measured: Baseline

  2. Three-day bladder diary (BD)

    BD contains the most critical parameters for measuring the frequency and severity of LUTS according to International Continence Society (ICS) recommendations and definitions. The 3-day bladder diary measures the frequency of urination, nocturia, urgency, and urge incontinence for 3 consecutive days. The average frequency of each symptom over three days will be considered the final result.

    Measured: Baseline

  3. King's Quality of Life Questionnaire (KHQ)

    One of the commonly used quality of life measures for urinary dysfunction is the King's Quality of Life Questionnaire. It is one of the most valid and widely used questionnaires that targets the quality of life in patients with urinary incontinence and precisely measures the impact of urinary incontinence symptoms on the quality of life.

    Measured: Baseline

  4. Incontinence Severity Index (ISI)

    Developed for use in epidemiological and clinical studies to identify women suffering from urinary incontinence, ISI, used in many different urinary incontinence studies, consists of two questions and the total score obtained by multiplying the frequency of urinary incontinence and the amount of urinary incontinence varies between 1 and 12.

    Measured: Baseline

  5. Neurogenic Bladder Symptom Score (NBSS)

    The Neurogenic Bladder Symptom Score (NBSS) is a discriminatory tool developed for use in patients with spinal cord injuries, multiple sclerosis, and spina bifida. There are a total of 22 questions covering incontinence, storage and voiding symptoms, as well as urinary complications associated with neurogenic bladder dysfunction.

    Measured: Baseline

  6. Overactive bladder form (OAB-v8)

    OAB-v8 is an eight-item screening test for overactive bladder (OAB) symptoms and has been validated in Turkish. The total score is between 0 and 40. Higher scores indicate OAB symptom burden and severity.

    Measured: After the 6-week intervention

  7. Three-day bladder diary (BD)

    BD contains the most critical parameters for measuring the frequency and severity of LUTS according to International Continence Society (ICS) recommendations and definitions. The 3-day bladder diary measures the frequency of urination, nocturia, urgency, and urge incontinence for 3 consecutive days. The average frequency of each symptom over three days will be considered the final result.

    Measured: After the 6-week intervention

  8. King's Quality of Life Questionnaire (KHQ)

    One of the commonly used quality of life measures for urinary dysfunction is the King's Quality of Life Questionnaire. It is one of the most valid and widely used questionnaires that targets the quality of life in patients with urinary incontinence and precisely measures the impact of urinary incontinence symptoms on the quality of life.

    Measured: After the 6-week intervention

  9. Incontinence Severity Index (ISI)

    Developed for use in epidemiological and clinical studies to identify women suffering from urinary incontinence, ISI, used in many different urinary incontinence studies, consists of two questions and the total score obtained by multiplying the frequency of urinary incontinence and the amount of urinary incontinence varies between 1 and 12.

    Measured: After the 6-week intervention

  10. Neurogenic Bladder Symptom Score (NBSS)

    The Neurogenic Bladder Symptom Score (NBSS) is a discriminatory tool developed for use in patients with spinal cord injuries, multiple sclerosis, and spina bifida. There are a total of 22 questions covering incontinence, storage and voiding symptoms, as well as urinary complications associated with neurogenic bladder dysfunction.

    Measured: After the 6-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start20 Nov 2023
  3. Primary completion20 Oct 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143397
Sponsor's protocol ID
Neurogenic Bladder
Status last verified
Nov 2025
First submitted
16 Nov 2023
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36274285
  • 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.

    PubMed 31939564

Questions about this trial

What is this clinical trial studying?

A study testing TTNS (Transcutaneous tibial nerve stimulation), PNS (Parasacral nerve stimulation) and Behavioral treatment in people with Multiple Sclerosis and Overactive Bladder Syndrome, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uroflowmetry (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06143397, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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