Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder

NCT06390488 | Not Yet Recruiting

• 1 other identifier: PamukkaleU.ftr-NYıldız-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Bladder, Overactive

Keywords

Idiopathic overactive bladder; Transcutaneous medial plantar nerve stimulation; Urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Improvement in incontinence episodes

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

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

Secondary Outcomes (8)

• 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

• 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 Quality of Life

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

• Anxiety and Depression level

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

Study Arms (2)

T-MPNS

EXPERIMENTAL

In this study, the stimulation device will be connected to the patient via channel 1, and active stimulation will be performed. Channel 2 will not be connected to the patient, thus no stimulation will be given through this channel. Both channels will utilize a stimulation protocol set to continuous mode with a frequency of 20 Hz and a pulse width of 200 ms. The intensity of the current for channel 1 (ranging from 0 to 50 mA) will be determined based on the comfort level of the patient after ensuring correct positioning. Correct positioning will be confirmed by observing a hallux reaction (plantar flexion of the big toe or, rarely, fanning of the fingers). T-MPNS sessions will be conducted twice a week for 6 weeks, with each session lasting 30 minutes. The intervention will consist of a 12-session T-MPNS treatment program.

Other: Transcutaneous medial plantar nerve stimulation (T-MPNS)

Sham T-MPNS

SHAM COMPARATOR

In the Sham T-MPNS group, patients will receive stimulation with the same electrotherapy device, same patient and electrode positioning, and identical current characteristics as the T-MPNS group. Channel 2 of the device will be connected to the patient without delivering stimulation, while channel 1 will not be connected but will display current intensity and treatment duration on the device screen. The current intensity on channel 1 will only be able to be increased up to 2-3 mA to prevent patients from exceeding this level. Patients will be advised that higher stimulations might negatively affect treatment outcomes. All patients, including those in the placebo group, will be informed that the absence of motor or sensory responses during treatment does not imply ineffectiveness, alleviating concerns about lack of sensation. Sham T-MPNS sessions will be conducted twice weekly for 6 weeks, with each session lasting 30 minutes, totaling 12 sessions.

Other: Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)

Interventions

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.

T-MPNS

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.

Sham T-MPNS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (20)

• 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 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.

  PMID: 27921161 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Tezer T, Yildiz N, Sarsan A, Alkan H. Short-term effect of magnetic stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial. Neurourol Urodyn. 2022 Aug;41(6):1380-1389. doi: 10.1002/nau.24957. Epub 2022 May 20.

  PMID: 35593007 BACKGROUND

• Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289. Epub 2013 Oct 14.

  PMID: 24118165 BACKGROUND

• Firinci S, Yildiz N, Alkan H, Aybek Z. Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2498-2508. doi: 10.1002/nau.24522. Epub 2020 Sep 22.

  PMID: 32960999 BACKGROUND

• O'Sullivan R, Karantanis E, Stevermuer TL, Allen W, Moore KH. Definition of mild, moderate and severe incontinence on the 24-hour pad test. BJOG. 2004 Aug;111(8):859-62. doi: 10.1111/j.1471-0528.2004.00211.x.

  PMID: 15270937 BACKGROUND

• Tarcan T, Mangır N, Özgür MÖ, Akbal C. OAB-V8 Overactive Bladder Questionnaire Validation Study. (Turkish) Üroloji Bülteni 2012;21:113-116. http://www.kontinansdernegi.org/userfiles/media/kontinans.galenos.com.tr/oab-v8-asiri-aktif-mesane-sorgulama-formu.pdf

  BACKGROUND

• Acquadro C, Kopp Z, Coyne KS, Corcos J, Tubaro A, Choo MS, Oh SJ. Translating overactive bladder questionnaires in 14 languages. Urology. 2006 Mar;67(3):536-40. doi: 10.1016/j.urology.2005.09.035.

  PMID: 16527574 BACKGROUND

• Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.

  PMID: 17083117 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Aydemir Ö, Güvenir T, Küey L ve ark. (1987) Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenirliliği. Türk Psikiyatri Dergisi, 8:280-287

  BACKGROUND

• Aygin, D., & Aslan, F. E. (2005). Kadin cinsel işlev ölçegi'nin Türkçeye uyarlamasi. Turkiye Klinikleri Journal of Medical Sciences, 25(3), 393-399

  BACKGROUND

• Kim SJ, Choi HW, Cho HJ, Hwang TK, Kim JC. The influence of preoperative bladder outlet obstruction on continence and satisfaction in patients with stress urinary incontinence after midurethral sling. Int Neurourol J. 2010 Dec;14(4):267-71. doi: 10.5213/inj.2010.14.4.267. Epub 2010 Dec 31.

  PMID: 21253340 BACKGROUND

• Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010 Nov;184(5):2001-6. doi: 10.1016/j.juro.2010.06.113. Epub 2010 Sep 20.

  PMID: 20850833 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Necmettin Yıldız, Prof.

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Emre Bezmez, M.D.

CONTACT

+902584444747; emrebezmez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 30, 2024
• Study Start: November 28, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)