Urinary Bladder, Overactive
Conditions
Keywords
Idiopathic overactive bladder, Urinary incontinence, perineal electrical stimulation, Intravaginal electrical stimulation
Brief summary
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of IVES vs perineal ES in women with idiopathic OAB. The main questions aimed to be answered are: Is Intravaginal Electrical Stimulation (IVES) or perineal ES more effective on clinical parameters related to incontinence and quality of life in women with idiopathic overactive bladder (OAB)? Participants (n:63) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 3 groups using a randomization table. The first group will receive IVES and bladder training (n:21), second group will receive perineal ES and bladder training (n:21) and third group will receive bladder training (n=21) . Measurements will be performed twice in total, before and at the end of treatment (8th week).
Interventions
OTHERIntravaginal ES
IVES will be performed in the lithotomy position using a vaginal probe and a stimulation device . IVES will be performed three days a week for 20 minutes per day for 8 weeks, totaling 24 sessions. Stimulation parameters will be a frequency of 10 Hz, a 5-10 second work-rest cycle, and a 100 ms pulse width. A symmetrical biphasic pulse wave can be delivered in the range of 1-100 mA (based on the patient's discomfort level feedback).
OTHERBT
A written brochure will then be provided as a program that can be implemented at home. In the first stage, women will be informed about the location of the BT, pelvic anatomy, and pathophysiology. Following this informational session, they will be demonstrated how to squeeze the BT at least once using digital palpation techniques to suppress urgency. In the second stage, which includes urgency suppression strategies, the aim is to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the BT several times in a row, taking deep breaths, focusing on another task for a while, and self-motivating themselves. In the third stage, a timed voiding program will be initiated. This will be carried out in two steps: timed voiding and increasing the time between voids by keeping a voiding diary. In the final stage, women will be encouraged to continue BT
OTHERPerineal ES
Perineal ES will be administered in the lithotomy position using a combined electrotherapy stimulation device with surface electrodes. Perineal ES will be administered 20 minutes per day, 3 days per week, for 8 weeks, for a total of 24 sessions. Stimulation parameters will be 10 Hz frequency, 5-10 s work-rest cycle, and 100 µs pulse width. A symmetrical biphasic current wave can be delivered in the 1-100 mA range (depending on the patient's discomfort level feedback). In this application, five 2 cm diameter surface electrodes will be used: four electrodes symmetrically in the perianal region and one electrode (ground-neutral electrode) on the leg. Patients will not perform voluntary contractions during ES. Surface electrodes will be used individually for each patient. Perineal ES sessions will be performed by a physical medicine and rehabilitation physician.
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over the age of 18 with a clinical diagnosis of idiopathic OAB * Intolerant or unresponsive to antimuscarinic or oral β3 adrenoceptor agonist (mirabegron) medications and not using them for at least 4 weeks * Ability to understand the procedures, advantages, and potential side effects * Ability to provide written, informed consent * Pelvic floor muscle (PFM) strength of 3/5 or higher (modified Oxford scale, minimum: 0 - maximum: 5)
Exclusion criteria
* Women with pure stress urinary incontinence * History of conservative treatment for OAB within the last 6 months (MI, IVES, perineal ES, etc.) * Pregnant or planning to become pregnant at the time of the study * Diagnosis of vaginal infection, urinary tract infection, or cancer * Women with urinary incontinence within the last 3 months Those who have undergone urogynecological surgery * Those with genital area disorders that may preclude the use of a vaginal probe or perineal electrode * Those diagnosed with stage 2 or higher according to the Pelvic Organ Prolapse Assessment (POP-Q) * Those with a pacemaker or implanted defibrillator * Those with neurogenic bladder or a history of neurological disease * Those with a urine residual of more than 100 ml detected by ultrasound (using an ultrasound device) * Those with allergies to condoms or lubricating gels used with a vaginal probe or perineometer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in rate incontinence episodes | Change from baseline Improvement in incontinence episodes at the 8th week after the treatment | Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 24-hour pad test | Change from baseline the severity of incontinence at the 8th week after the treatment | The 24-hour pad test was carried out to evaluate the severity of incontinence |
| Symptom severity | Change from baseline symptom severity at the 8th week after the treatment | Overactive Bladder Questionnaire (OAB-V8) will be used to evaluate symptom severity in women with OAB in the study. The OAB-V8 consists of 8 questions in which patients can be classified as symptom severity: none (0), very little (1), a little (2), quite a few (3), very (4), and too many (5). The total score ranges from 0-40. |
| Frequency of voiding, nocturia, number of pads | Change from baseline Frequency of voiding, nocturia, number of pads at the 8th week after the treatment | The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary. |
| The Quality of Life | Change from baseline the Quality of Life at the 8th week after the treatment | The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence. The scale consists of 7 questions and is scored on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 21 points. High scores mean bad results. |
| Anxiety and Depression level | Change from baseline anxiety and Depression level at the 8th week after the treatment | The Hospital Anxiety and Depression Scale (HAD), validated and reliability tested in Turkey in 1987, assesses levels of anxiety and depression. It comprises 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: questions 1, 3, 5, 7, 9, 11, and 13 for anxiety, and questions 2, 4, 6, 8, 10, 12, and 14 for depression. In Turkey, cutoff scores are 10/11 for anxiety and 7/8 for depression, indicating risk. |
| Assessment of sexual functions Assessment of sexual functions | Change from baseline assessment of sexual functions at the 8th week after the treatment | In the evaluation of sexual function, the Female Sexual Function Index questionnaire is used, consisting of 19 questions assessing six main factors: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain/discomfort. The highest possible total raw score is 95, while the lowest is 4. After multiplying the coefficients, the highest score is 36, and the lowest is 2. Impact coefficients used for scoring are: 0.6 for sexual desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. An Female Sexual Function Index score below 26.55 is indicative of sexual dysfunction |
| Cure and improvement rates | Change from baseline cure and improvement rates at the 8th week after the treatment | Cure and improvement rates will be recorded in all groups at the end-of-treatment assessments. Values under 1.3 g in the 24-hour pad test will be considered as "cure", while a 50% or greater reduction in wet weight compared to baseline measurements at the end of treatment will be considered as "improvement |
| Treatment Satisfaction Level | Change from baseline Treatment Satisfaction Level at the 8th week after the treatment | At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied). |
| Pelvic Floor Muscle (PFM) Strength | Change from baseline Pelvic Floor Muscle (PFM) Strength at the 8th week after the treatment | PFM strength will be assessed using the Peritron 9300 device |
| Side Effects | 8th week | All patients will be questioned about side effects such as numbness, fatigue, pain in and around the pelvic floor muscle, and changes and discomfort associated with defecation, drowsiness, headache, fatigue, and asthenia. |
Countries
Turkey (Türkiye)
Contacts
CONTACTRabia Melis Gundogan M.D.
STUDY_DIRECTORNecmettin YILDIZ Prof.
Pamukkale University
Outcome results
None listed