Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Other: Transcutaneous MPN stimulation (T-MPNS)Other: Transcutaneous tibial nerve stimulation (TTNS)Other: BT (Control group)
- Registration Number
- NCT06349694
- Lead Sponsor
- Pamukkale University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Women over the age of 18 with clinical diagnosis of idiopathic OAB
- Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
- Able to understand the procedures, advantages and possible side effects
- Willing and able to complate the voiding diary and QoL questionnaire
- The strength of PFM 3/5 and more
- Women with stress urinary incontinence
- History of conservative therapy (BT, T-MPNS and TTNS/PTNS) within 6 months
- Pregnancy or intention to become pregnant during the study
- Current vulvovaginitis or urinary tract infections or malignancy
- Anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes
- More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
- Cardiac pacemaker, implanted defibrillator
- Previous urogyneceological surgery within 3 months
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of PVR volume more than 100 ml
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BT plus T-MPNS Transcutaneous MPN stimulation (T-MPNS) T-MPNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus T-MPNS treatment program BT plus TTNS Transcutaneous tibial nerve stimulation (TTNS) TTNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus TTNS treatment program BT (Control group) BT (Control group) Information about BT will be explained to patients for 30 min. Then written form about BT will be given to be implemented as a home program.
- Primary Outcome Measures
Name Time Method Improvement in incontinence episodes (positive response rate) Change from baseline positive response rate at the 6th week after the treatment Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders
- Secondary Outcome Measures
Name Time Method The severity of incontinence Change from baseline the 24-hour pad test at the 6th week after the treatment The 24-hour pad test will be carried out to evaluate the severity of incontinence
Treatment satisfaction Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment The change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied)
Symptom severity Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in women with OAB
Quality of life (IIQ7) Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment The Quality of Life-Incontinence Impact Questionnaire (IIQ7)
Frequency of voiding, nocturia, number of pads 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 The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.
FSFI Change from baseline point of FSFI at the 6th week after the treatment 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
Cure-improvement rates Change from baseline cure and improvements at the 6th 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"
The Hospital Anxiety and Depression Scale (HAD) Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment 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.
Trial Locations
- Locations (1)
Pamukkale University
🇹🇷Denizli, Turkey