Repetitive Transcranial Magnetic Stimulation (rTMS) on Neurogenic Overactive Bladder in Stroke

NCT05557175 | Completed DMC FDA Device

• 1 other identifier: Ref No. ZVSV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Neurogenic overactive bladder (NOAB) presents with urgency incontinence. Existing NOAB management is expensive, lacks standardized regimens, or is invasive. Therefore, evaluating the effectiveness of non-invasive repetitive transcranial magnetic stimulation (rTMS) for NOAB management among stroke survivors remains crucial. Objectives: Evaluate the effects of active-rTMS compared to sham-rTMS among stroke survivors with NOAB, the interventions' cost-effectiveness and explore their experiences qualitatively.

Conditions

Urgency Urinary Incontinence; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Overactive bladder symptom score (OABSS) questionnaire.

  The OABSS is reported to be a reliable and valid questionnaire for the quantitative evaluation of overactive bladder symptoms in the Hong Kong population (ICC score: 0.82). The measure comprised four questions on OAB symptoms with domain maximum scores ranging from 2 to 5: daytime frequency (two points), night-time frequency (three points), urgency (five points), and UUI (five points). The OABSS total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. According to severity, mild is defined as a score of 3 to 5 points, moderate as a score of 6 to 11 points, and severe as a score of 12 or more points.

  Pre intervention, post intervention (4 weeks) and follow up (4 weeks)

Secondary Outcomes (3)

• Incontinence Quality-of-Life Questionnaire (I-QoL)

  Pre intervention, post intervention (4 weeks) and follow up (4 weeks)

• The Brief Resilience Scale

  Pre intervention, post intervention (4 weeks) and follow up (4 weeks)

• The 5-level EQ-5D (EQ-5D-5L)

  Pre intervention, post intervention (4 weeks) and follow up (4 weeks)

Study Arms (2)

Active rTMS group

EXPERIMENTAL

Device: Repetitive transcranial magnetic stimulation

Sham rTMS group

SHAM COMPARATOR

Device: Sham rTMS

Interventions

Repetitive transcranial magnetic stimulation DEVICE

The active rTMS group will receive a 1 Hz inhibitory low-frequency rTMS protocol hotspot of the contra-lessional primary motor cortex (M1), will deliver a continuous pulse of 1 pulse per second totalling 1200 pulses of 80% active motor threshold stimulation. The duration of the stimulation will last for 20 minutes thrice a week for four weeks (12 sessions). The motor threshold will be the minimum single-pulse TMS intensity necessary to elicit a motor-evoked potential greater than 50μV in more than 5 out of 10 consecutive trials. The standard 70 mm figure-of-eight air-cooled coil handle (MagPro) will be held at right angle to the skull for effective M1 stimulation. The participants in the active rTMS groups will receive a subthreshold stimulation intensity for muscle contraction with no painful peripheral sensation

Active rTMS group

Sham rTMS DEVICE

The sham rTMS will be applied using the same parameters as the active rTMS but the coil will be rotated 90° away from the scalp so that minimal or no flow of current will be induced

Sham rTMS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors aged between 18-80 years diagnosed with NOAB
• Urodynamic findings confirming detrusor overactivity
• Experience moderate (OABSS scores: 6-11 points) to severe NOAB (OABSS scores: 12 points and above)
• Obtain a Mini-Mental State Examination (MMSE) score of ≥ 24
• Be willing to be randomized

You may not qualify if:

• Presence of metals in the cranium, intracardiac lines, increased intracranial pressure, heart diseases, or cardiac pacemaker, use of sacral neuro-modulation
• Pregnancy or less than six months postpartum stage
• Patients with a family history of epilepsy or seizures
• Patients taking tricyclic antidepressants or neuroepileptics
• Participation in any other research project related to urinary incontinence; contra-indicated to MRI, urologic cancer, prostatic pathology, severe pelvic pain, six weeks post-surgery and non-neurogenic bladder

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (16)

• Przydacz M, Denys P, Corcos J. What do we know about neurogenic bladder prevalence and management in developing countries and emerging regions of the world? Ann Phys Rehabil Med. 2017 Sep;60(5):341-346. doi: 10.1016/j.rehab.2017.02.008. Epub 2017 Jun 13.

  PMID: 28623162 BACKGROUND

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  PMID: 10753993 BACKGROUND

• Manack A, Motsko SP, Haag-Molkenteller C, Dmochowski RR, Goehring EL Jr, Nguyen-Khoa BA, Jones JK. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011 Mar;30(3):395-401. doi: 10.1002/nau.21003. Epub 2010 Sep 29.

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• Takahashi S, Kitamura T. Overactive bladder: magnetic versus electrical stimulation. Curr Opin Obstet Gynecol. 2003 Oct;15(5):429-33. doi: 10.1097/00001703-200310000-00012.

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• Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.

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• Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.

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• Klomjai W, Katz R, Lackmy-Vallee A. Basic principles of transcranial magnetic stimulation (TMS) and repetitive TMS (rTMS). Ann Phys Rehabil Med. 2015 Sep;58(4):208-213. doi: 10.1016/j.rehab.2015.05.005. Epub 2015 Aug 28.

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• Yani MS, Wondolowski JH, Eckel SP, Kulig K, Fisher BE, Gordon JE, Kutch JJ. Distributed representation of pelvic floor muscles in human motor cortex. Sci Rep. 2018 May 8;8(1):7213. doi: 10.1038/s41598-018-25705-0.

  PMID: 29740105 BACKGROUND

• Griffiths D. Neural control of micturition in humans: a working model. Nat Rev Urol. 2015 Dec;12(12):695-705. doi: 10.1038/nrurol.2015.266. Epub 2015 Dec 1.

  PMID: 26620610 BACKGROUND

• Griffiths D, Clarkson B, Tadic SD, Resnick NM. Brain Mechanisms Underlying Urge Incontinence and its Response to Pelvic Floor Muscle Training. J Urol. 2015 Sep;194(3):708-15. doi: 10.1016/j.juro.2015.03.102. Epub 2015 Mar 28.

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  PMID: 25034472 BACKGROUND

• Kannan P, Cheung KK, Lau BW, Li L, Chen H, Sun F. A mixed-methods study to evaluate the effectiveness and cost-effectiveness of aerobic exercise for primary dysmenorrhea: A study protocol. PLoS One. 2021 Aug 16;16(8):e0256263. doi: 10.1371/journal.pone.0256263. eCollection 2021.

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  PMID: 17695343 BACKGROUND

• Yani MS, Fenske SJ, Rodriguez LV, Kutch JJ. Motor cortical neuromodulation of pelvic floor muscle tone: Potential implications for the treatment of urologic conditions. Neurourol Urodyn. 2019 Aug;38(6):1517-1523. doi: 10.1002/nau.24014. Epub 2019 May 1.

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• Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Screening questionnaire before TMS: an update. Clin Neurophysiol. 2011 Aug;122(8):1686. doi: 10.1016/j.clinph.2010.12.037. Epub 2011 Jan 11. No abstract available.

  PMID: 21227747 BACKGROUND

• Xu L, Fu C, Zhang Q, Xiong F, Peng L, Liang Z, Chen L, He C, Wei Q. Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial. BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.

  PMID: 32759239 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcranial Magnetic Stimulation

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The therapist and the participants will be blinded in the recruitment, randomization and treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active and Sham rTMS groups

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 27, 2022
• Study Start: November 9, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: May 3, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)