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Clinical Trials/NCT06143397
NCT06143397
Completed
N/A

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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 site in 1 country42 target enrollmentNovember 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Enrollment
42
Locations
1
Primary Endpoint
Uroflowmetry
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
October 30, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible Party
Principal Investigator
Principal Investigator

Busra Aydin Erkilic

Physiotherapist

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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)

Outcomes

Primary Outcomes

Uroflowmetry

Time Frame: After the 6-week intervention

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.

Post voiding residue (PVR)

Time Frame: After the 6-week intervention

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

Secondary Outcomes

  • Overactive bladder form (OAB-v8)(After the 6-week intervention)
  • Neurogenic Bladder Symptom Score (NBSS)(After the 6-week intervention)
  • King's Quality of Life Questionnaire (KHQ)(After the 6-week intervention)
  • Incontinence Severity Index (ISI)(After the 6-week intervention)
  • Three-day bladder diary (BD)(After the 6-week intervention)

Study Sites (1)

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