Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urinary Bladder, Overactive
- Sponsor
- Pamukkale University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Improvement in incontinence episodes
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Necmettin Yildiz
Professor Doctor
Pamukkale University
Eligibility Criteria
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 complete the voiding diary and QoL questionnaire
- •The strength of pelvic floor muscles 3/5 and more
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Improvement in incontinence episodes
Time Frame: 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 Outcomes
- Anxiety and Depression level(Change from baseline anxiety and Depression level at the 6th week after the treatment)
- Cure and improvement rates(Change from baseline cure and improvement rates at the 6th week after the treatment)
- 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 severity of incontinence(Change from baseline the severity of incontinence at the 6th week after the treatment)
- Symptom severity(Change from baseline symptom severity at the 6th week after the treatment)
- The Quality of Life(Change from baseline the Quality of Life at the 6th week after the treatment)
- Assessment of sexual functions Assessment of sexual functions(Change from baseline assessment of sexual functions at the 6th week after the treatment)
- Treatment Satisfaction Level(Change from baseline Treatment Satisfaction Level at the 6th week after the treatment)