Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Other: Transcutaneous medial plantar nerve stimulation (T-MPNS)Other: Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)
- Registration Number
- NCT06390488
- Lead Sponsor
- Pamukkale University
- Brief Summary
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB.
The main questions aimed to be answered are:
What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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 complete the voiding diary and QoL questionnaire
- The strength of pelvic floor muscles 3/5 and more
- Women with stress urinary incontinence
- History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/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 nerve region on inner foot 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 urogynecological surgery within 3 months
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of post-void residual volume more than 100 ml
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T-MPNS Transcutaneous medial plantar nerve stimulation (T-MPNS) In this study, the stimulation device will be connected to the patient via channel 1, and active stimulation will be performed. Channel 2 will not be connected to the patient, thus no stimulation will be given through this channel. Both channels will utilize a stimulation protocol set to continuous mode with a frequency of 20 Hz and a pulse width of 200 ms. The intensity of the current for channel 1 (ranging from 0 to 50 mA) will be determined based on the comfort level of the patient after ensuring correct positioning. Correct positioning will be confirmed by observing a hallux reaction (plantar flexion of the big toe or, rarely, fanning of the fingers). T-MPNS sessions will be conducted twice a week for 6 weeks, with each session lasting 30 minutes. The intervention will consist of a 12-session T-MPNS treatment program. Sham T-MPNS Sham Transcutaneous medial plantar nerve stimulation (T-MPNS) In the Sham T-MPNS group, patients will receive stimulation with the same electrotherapy device, same patient and electrode positioning, and identical current characteristics as the T-MPNS group. Channel 2 of the device will be connected to the patient without delivering stimulation, while channel 1 will not be connected but will display current intensity and treatment duration on the device screen. The current intensity on channel 1 will only be able to be increased up to 2-3 mA to prevent patients from exceeding this level. Patients will be advised that higher stimulations might negatively affect treatment outcomes. All patients, including those in the placebo group, will be informed that the absence of motor or sensory responses during treatment does not imply ineffectiveness, alleviating concerns about lack of sensation. Sham T-MPNS sessions will be conducted twice weekly for 6 weeks, with each session lasting 30 minutes, totaling 12 sessions.
- Primary Outcome Measures
Name Time Method Improvement in incontinence episodes Change from baseline Improvement in incontinence episodes at the 6th week after the treatment Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
- Secondary Outcome Measures
Name Time Method Anxiety and Depression level Change from baseline anxiety and Depression level at the 6th 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.
Cure and improvement rates Change from baseline cure and improvement rates 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".
Frequency of voiding, nocturia, number of pads Change from baseline Frequency of voiding, nocturia, number of pads 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.
The severity of incontinence Change from baseline the severity of incontinence at the 6th 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 6th 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.
The Quality of Life Change from baseline the Quality of Life at the 6th week after the treatment The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence
Assessment of sexual functions Assessment of sexual functions Change from baseline assessment of sexual functions at the 6th 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
Treatment Satisfaction Level Change from baseline Treatment Satisfaction Level at the 6th 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).
Trial Locations
- Locations (1)
Pamukkale University
🇹🇷Denizli, Turkey