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

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).

Interventions

• Other Transcutaneous medial plantar nerve stimulation (T-MPNS)
  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 in
• Other Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)
  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 outcome measures

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

Secondary outcome measures (8)

• The severity of incontinence [Time frame: Change from baseline the severity of incontinence at the 6th week after the treatment]
• Symptom severity [Time frame: Change from baseline symptom severity at the 6th week after the treatment]
• 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 Quality of Life [Time frame: Change from baseline the Quality of Life at the 6th week after the treatment]
• Anxiety and Depression level [Time frame: Change from baseline anxiety and Depression level at the 6th week after the treatment]
• Assessment of sexual functions Assessment of sexual functions [Time frame: Change from baseline assessment of sexual functions at the 6th week after the treatment]
• Cure and improvement rates [Time frame: Change from baseline cure and improvement rates at the 6th week after the treatment]
• Treatment Satisfaction Level [Time frame: Change from baseline Treatment Satisfaction Level at the 6th week after the treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

Turkey (Türkiye) · 1 center

• Pamukkale University — Denizli

Publications

• Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 PMID 27921161
• C.K. Harding, M.C. Lapitan, S. Arlandis, K. Bø, H. Cobussen-Boekhorst, E. Costantini, et al. The European Association of Urology (EAU) Guidelines. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. In: EAU Guidelines, 2023 (Internet). Available online at: https://uroweb.org/guidelines/non-neurogenic-female-luts
• Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23. PMID 25623739
• de Groat WC, Yoshimura N. Anatomy and physiology of the lower urinary tract. Handb Clin Neurol. 2015;130:61-108. doi: 10.1016/B978-0-444-63247-0.00005-5. PMID 26003239
• de Groat WC, Griffiths D, Yoshimura N. Neural control of the lower urinary tract. Compr Physiol. 2015 Jan;5(1):327-96. doi: 10.1002/cphy.c130056. PMID 25589273
• Sonmez R, Yildiz N, Alkan H. Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101486. doi: 10.1016/j.rehab.2021.101486. Epub 2021 Nov 11. PMID 33429090
• Yildiz N, Sonmez R. Transcutaneous medial plantar nerve stimulation in women with idiopathic overactive bladder. Investig Clin Urol. 2023 Jul;64(4):395-403. doi: 10.4111/icu.20230009. PMID 37417565
• Burgio KL, Goode PS, Locher JL, Umlauf MG, Roth DL, Richter HE, Varner RE, Lloyd LK. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2293-9. doi: 10.1001/jama.288.18.2293. PMID 12425706

Identifiers

NCT: NCT06390488 · PamukkaleU.ftr-NYıldız-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗