Clinical trial NCT06390488: Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder
Official title: Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Bladder, Overactive
Keywords: Idiopathic overactive bladder
Transcutaneous medial plantar nerve stimulation
Urinary incontinence
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Improvement in incontinence episodes
timeFrame: Change from baseline Improvement in incontinence episodes at the 6th week after the treatment
Secondary outcomes:
measure: The severity of incontinence
timeFrame: Change from baseline the severity of incontinence at the 6th week after the treatment
measure: Symptom severity
timeFrame: Change from baseline symptom severity at the 6th week after the treatment
measure: Frequency of voiding, nocturia, number of pads
timeFrame: Change from baseline Frequency of voiding, nocturia, number of pads at the 6th week after the treatment
measure: The Quality of Life
timeFrame: Change from baseline the Quality of Life at the 6th week after the treatment
measure: Anxiety and Depression level
timeFrame: Change from baseline anxiety and Depression level at the 6th week after the treatment
measure: Assessment of sexual functions Assessment of sexual functions
timeFrame: Change from baseline assessment of sexual functions at the 6th week after the treatment
measure: Cure and improvement rates
timeFrame: Change from baseline cure and improvement rates at the 6th week after the treatment
measure: Treatment Satisfaction Level
timeFrame: Change from baseline Treatment Satisfaction Level at the 6th week after the treatment
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Necmettin Yıldız, Prof.
role: STUDY_DIRECTOR
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