Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder

N/ANot Yet RecruitingNCT06390488

Pamukkale University40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Urinary Bladder, Overactive

Interventions

T-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive.

Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)OTHER

Sham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders

Time frame: Change from baseline Improvement in incontinence episodes at the 6th week after the treatment

Secondary Outcomes

The severity of incontinence

The 24-hour pad test was carried out to evaluate the severity of incontinence

Time frame: Change from baseline the severity of incontinence at the 6th week after the treatment

Symptom severity

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.

Time frame: Change from baseline symptom severity at the 6th week after the treatment

Frequency of voiding, nocturia, number of pads

The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.

Time frame: Change from baseline Frequency of voiding, nocturia, number of pads at the 6th week after the treatment

The Quality of Life

The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence

Time frame: Change from baseline the Quality of Life at the 6th week after the treatment

Anxiety and Depression level

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.

Time frame: Change from baseline anxiety and Depression level at the 6th week after the treatment

Assessment of sexual functions Assessment of sexual functions

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

Time frame: Change from baseline assessment of sexual functions at the 6th week after the treatment

Cure and improvement rates

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".

Time frame: Change from baseline cure and improvement rates at the 6th week after the treatment

Treatment Satisfaction Level

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).

Time frame: Change from baseline Treatment Satisfaction Level at the 6th week after the treatment