Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
Conditions
Keywords
tibial nerve stimulation
Brief summary
This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder
Detailed description
Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.
Interventions
BEHAVIORALBladder training
Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom
A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcome assessor and investigator that assesses the patients will be blind to the study groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11. * Post voiding residue levels less than 100 ml. * Women aged between 18-70
Exclusion criteria
* Prior history of pelvic surgery * Pelvic organ prolapsus of grade 2 or more. * Current urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urination frequency | 1 day | The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period. |
| Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire | 1 day | This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life. King's quality of life questionnaire | 1 day | This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period. |
| Level of satisfaction with the treatment. Visual analog scale | 1 day | After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale. |
| Incontinence impact questionnaire-7. | 1 day | This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEce Cinar, MD
Backup ContactYesim Akkoc, MD
Outcome results
None listed