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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Status: Completed

Conditions: Multiple Sclerosis; Overactive Bladder Syndrome

Treatments: Device: Sham stimulation; Device: PNS (Parasacral nerve stimulation); Behavioral: Behavioral treatment; Device: TTNS (Transcutaneous tibial nerve stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT06143397

Neurogenic Bladder

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

42 participants in 3 patient groups

TTNS (Transcutaneous tibial nerve stimulation)

Experimental group

Treatment:

Device: TTNS (Transcutaneous tibial nerve stimulation)

Behavioral: Behavioral treatment

PNS (Parasacral nerve stimulation)

Experimental group

Treatment:

Behavioral: Behavioral treatment

Device: PNS (Parasacral nerve stimulation)

Sham stimulation

Sham Comparator group

Treatment:

Behavioral: Behavioral treatment

Device: Sham stimulation