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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:
Our main aim was to compare effectiveness of tibial nerve stimulation in patiens with overactive bladder with stroke.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, TNS | Active Comparator | 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. All patiens were followed for PFTE and BT according to standard schedule. |
|
| Sham TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, Sham TNS | Sham Comparator | 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 down. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibial Nerve Stimulation with TENS device | Device | Tibial nerve stimulation was applied with TENS device transcutaneously and electrodes were positioned in medial part of the ankle. Negative transcutaneous electrode was positioned 3 centimeter posteriorly to the medial malleol. And positive transcutaneous electrode was positioned 10 centimeter above the negative electrode. |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic Study Parameters | Maximum Cystometric Capacity (mL) | 6 weeks |
| Overactive Bladder Symptom Scoring | A validated symptom scoring to detect the patients with overactive bladder symptoms and classifying them as low/moderate/high OABS. Higher results mean worse outcome | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ICIQ-SF | a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. Higher results mean worse outcome. | 6 weeks |
| King's Health Questionaire | Subjective measure of severity of urinary incontinence consists of nine domains: two single-item domains (general health perceptions and incontinence impact), and seven multi-item domains (role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity/coping. Higher results mean worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Umay Ekinci, MD | University of Health Sciences, Department of PM&R | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziler PMR, Training and Research Hospital, Department of PMR | Ankara | Cankaya | 06100 | Turkey (Türkiye) |
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| Pelvic muscle training exercise with bladder training | Behavioral | 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. All patients were followed for PFTE and BT according to given standard schedule. |
|
| 6 weeks |
| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D020521 | Stroke |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
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