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NCT Number: NCT06390488

Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder

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).

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous medial plantar nerve stimulation (T-MPNS)

Other

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.

Primary outcomes

  1. 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

  1. The severity of incontinence

    Time frame: 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

  2. Symptom severity

    Time frame: 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.

  3. Frequency of voiding, nocturia, number of pads

    Time frame: 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.

  4. The Quality of Life

    Time frame: 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

  5. Anxiety and Depression level

    Time frame: 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.

  6. Assessment of sexual functions Assessment of sexual functions

    Time frame: 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

  7. Cure and improvement rates

    Time frame: 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".

  8. Treatment Satisfaction Level

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Bezmez, M.D.

CONTACT

[email protected]

+902584444747

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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