Clinical trial NCT06143397: Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Overactive Bladder Syndrome
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2023-11-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Uroflowmetry
timeFrame: Baseline
measure: Uroflowmetry
timeFrame: After the 6-week intervention
measure: Post voiding residue (PVR)
timeFrame: Baseline
measure: Post voiding residue (PVR)
timeFrame: After the 6-week intervention
Secondary outcomes:
measure: Overactive bladder form (OAB-v8)
timeFrame: Baseline
measure: Three-day bladder diary (BD)
timeFrame: Baseline
measure: King's Quality of Life Questionnaire (KHQ)
timeFrame: Baseline
measure: Incontinence Severity Index (ISI)
timeFrame: Baseline
measure: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: Baseline
measure: Overactive bladder form (OAB-v8)
timeFrame: After the 6-week intervention
measure: Three-day bladder diary (BD)
timeFrame: After the 6-week intervention
measure: King's Quality of Life Questionnaire (KHQ)
timeFrame: After the 6-week intervention
measure: Incontinence Severity Index (ISI)
timeFrame: After the 6-week intervention
measure: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: After the 6-week intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi
Study officials:
References:
citation: 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.
citation: 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.