Clinical trial NCT06247033: Evaluation of the Efficacy of Transcutaneous Tibial Nerve Stimulation on Post-Stroke Overactive Bladder
Official title: Evaluation of the Efficacy of Transcutaneous Tibial Nerve Stimulation on Post-Stroke Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urge
Stroke
Neurogenic Bladder
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to comparing the efficacies of different managements in patients with overactive bladder symptoms with stroke

The main question it aims to answer are:

* Are pelvic floor training exercises and bladder training enough to ease the symptoms of overactive bladder in patients with stroke?
* Is tibial nerve stimulation really effective and does it decrease the need of medications in patients with overactive bladder with stroke? Participants are questioned if they have the symptoms of overactive bladder. After urodynamic evaluation, they are separated in 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks.

Our main aim was to compare effectiveness of tibial nerve stimulation in patiens with overactive bladder with stroke.

Detailed description: A sham-controlled double-blinded randomized study was undertaken. 28 patients with chronic stroke were randomized into 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks.

In both groups, patients are followed for completing the standart schedule of PFTE and BT; and excluded from our study if their rates below %80 according to exercise and training schedule.

Study group was followed with tibial nerve stimulation for 6 weeks, 2 sessions in a week, for 30 minutes. Stimulation was performed with TENS device, with settings of 10 Hz frequency, 200 msn wavelenght, continuous symetrical biphasic current. Amptlitude was increased just below the motor range that cause flexion in toes.

Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut off. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes.

After 6 weeks, both groups were evaluated with urodynamic study for the second time.

ICIQ-SF, King's Health Questionaire, Overactive Bladder Syndrome Symptom Scoring and urodynamic study parameters were examined in both pre- and post-treatment period.

Results were compared to see if there is any difference in the patients who followed with TNS and also pre-post treatment symptoms with PFTE and BT.

Eligibility criteria: Inclusion Criteria:

* Stroke patients who applied to our hospital with the illness interval of 6 months-24 months
* Cooperated patients with mini mental test 18 and above
* Patients who willing to be a participant
* Patients with scoring of OABSS 3 and above (at least 2 points must be gained from question 3.) will be evaluated with urodynamic study and only the patients with overactive detrusor findings during urodynamic study will be included.

Exclusion Criteria:

* Patients who not willing to be a participant
* Psychiatric or cognitive impairment, MMT \< 18
* Spasticity that effects whole body, MAS 3 and above
* Urinary symptoms before stroke
* Global or sensorial aphasia
* Cardiac pacemaker
* Urinary tract infection
* Benign prostate hypertrophy
* Already receiving any treatment because of neurogenic bladder
* History of botulinum toxin injection to the detrusor muscle
* Active malignancy
* Pregnants
* Post-void residue above 200 mL

Primary outcomes:
measure: Urodynamic Study Parameters
timeFrame: 6 weeks
measure: Overactive Bladder Symptom Scoring
timeFrame: 6 weeks
Secondary outcomes:
measure: ICIQ-SF
timeFrame: 6 weeks
measure: King's Health Questionaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler PMR, Training and Research Hospital, Department of PMR
state: Cankaya
Study officials:
affiliation: University of Health Sciences, Department of PM&R
name: Umay Ekinci, MD
role: PRINCIPAL_INVESTIGATOR
References: