Overactive bladder. Overactive bladder
Conditions
Interventions
Intervention 1: Intervention group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for all groups to ensure that neither group is deprived of primary and supportive treatmen
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Individuals aged 18 or older with Overactive Bladder (OAB) who have experienced urinary urgency, frequency (more than eight times a day), nocturia (waking up more than twice at night), and/or urgency urinary incontinence (an average of eight or more urinations in 24 hours and three or more urgencies, with severity levels of 3—severe urgency or 4—urgency incontinence) with or without incontinence over a period of three days. Participants must have experienced symptoms for at least three months and provide informed consent.
Exclusion criteria
Exclusion criteria: - Individuals with neurological disorders affecting bladder function - Patients currently receiving other medications for OAB or those who have recently undergone bladder surgery. Pregnant or breastfeeding women Individuals with stress or mixed incontinence Presence of a urinary catheter Evidence of a symptomatic urinary tract infection, chronic bladder inflammation, or stones Previous pelvic radiation therapy, or current malignancy Patients with implanted electronic devices (such as pacemakers) Those with active skin infections or lesions at the electrode placement site. Individuals with epilepsy or a history of seizures Patients with severe cardiac conditions or other serious systemic diseases High blood pressure is defined as systolic blood pressure (SBP) greater than 180 mmHg or diastolic blood pressure (DBP) greater than 110 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICIQ-OAB Score: A 4-item questionnaire with a score range of 0-16, where higher scores indicate greater severity of overactive bladder symptoms.Mild OAB: Total score of 5 or lessModerate OAB: Total score between 6 and 11Severe OAB: Total score of 12 or more. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian ICIQ-OAB questionnaire.;The score of the ICIQ-UI SF questionnaire: It is a 4-item questionnaire with a scoring range of 0-21. This questionnaire is used to evaluate the frequency, severity, and impact on quality of life of urinary incontinence in men and women in research and clinical practice worldwide. 0: No urinary incontinence exists. 1-5: Mild incontinence; may not have a significant impact on quality of life. 6-12: Moderate incontinence; likely affects daily activities. 13-21: Severe incontinence; has a significant impact on quality of life and daily functioning. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian ICIQ-UI SF questionnaire.;The LUTS-QoL questionnaire score: A 20-item questionnaire for evaluating the quality of life in individuals with urinary incontinence. The minimum and maximum scores on this questionnaire are 19 and 76, respectively, with lower scores indicating better quality of life. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian LUTS-QoL questionnaire.;The Female Sexual Function Index (FSFI) is a valid 19-question questionnaire that evaluates female sexual function in six domains. Higher scores indicate better sexual function. The total FSFI score is calculated by summing the scores of individual domains, with a maximum possible score of 36. Scores below 26.55 are typically considered indicative of sexual dysfunction. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the val | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence and severity of any side effects related to treatment with parasacral TENS will be recorded and evaluated at the same time intervals (initially, 3 months, and 6 months after treatment). Therefore, the primary outcome of this study is the change in the severity of OAB symptoms, which will be measured using standard tools. Secondary outcomes will also include changes in quality of life and the occurrence of potential side effects resulting from the treatment. Timepoint: Initially and at 2 and 4 months after treatment. Method of measurement: The treatment is defined using treatment-emergent adverse events (TEAEs). A TEAE is defined as a side effect that begins after the start of the experimental drug treatment; or if the event has been ongoing from the beginning and has become serious, it is related to the experimental drug or has resulted in death, discontinuation, interruption, or reduction of the experimental treatment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Sattarpour
Tabriz University of Medical Sciences
Outcome results
None listed