Urinary Bladder, Overactive
Conditions
Keywords
Idiopatic overactive bladder, Transcutaneous medial plantar nerve stimulation, Transcutaneous tibial nerve stimulation
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.
Interventions
OTHERTranscutaneous MPN stimulation (T-MPNS)
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.
OTHERBT (Control group)
Conventional bladder training
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 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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) |
| 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 |
| 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 |
| 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) |
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactRabia Melis Gündoğan, M.d
Outcome results
None listed