Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated. The main questions we aim to answer are: Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
The main questions we aim to answer are: Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
Transcutaneous MPN stimulation (T-MPNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.
Transcutaneous tibial nerve stimulation (TTNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.
Conventional bladder training
Pamukkale University
Denizli, Turkey (Türkiye)
Improvement in incontinence episodes (positive response rate)
Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders
Time frame: Change from baseline positive response rate at the 6th week after the treatment
The severity of incontinence
The 24-hour pad test will be carried out to evaluate the severity of incontinence
Time frame: Change from baseline the 24-hour pad test at the 6th week after the treatment
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in women with OAB
Time frame: Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment
Frequency of voiding, nocturia, number of pads
The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.
Time frame: Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment
Quality of life (IIQ7)
The Quality of Life-Incontinence Impact Questionnaire (IIQ7)
Time frame: Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment
The Hospital Anxiety and Depression Scale (HAD)
The Hospital Anxiety and Depression Scale (HAD), developed by Zigmond and Snaith in 1983, with its validity and reliability study conducted in Turkey by Aydemir et al. in 1987, assesses anxiety and depression levels. It consists of 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: 1, 3, 5, 7, 9, 11, and 13 for anxiety, and 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.
Time frame: Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment
FSFI
In the evaluation of sexual function, the FSFI 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 FSFI score below 26.55 is indicative of sexual dysfunction
Time frame: Change from baseline point of FSFI at the 6th week after the treatment
Cure-improvement rates
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"
Time frame: Change from baseline cure and improvements at the 6th week after the treatment
Treatment satisfaction
The change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied)
Time frame: Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment
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