NCT05557175

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

A Mixed-methods Evaluation of the Clinical and Cost-effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neurogenic Overactive Bladder in Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Summary Background: 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. Hypothesis: Active-rTMS will reduce NOAB symptom severity for stroke survivors, interventions' cost and assist in gaining insight into the NOAB patients' experiences. Methods: This study will be a randomised-sham-controlled, double-blinded trial, with embedded qualitative and cost-effectiveness studies. Snowball-convenience sampling technique and computer-generated randomisation will be adopted to recruit 30 participants into active-rTMS and sham-rTMS groups each. Active-rTMS participants will receive a continuous 1 pulse per second 1200 pulses of low-frequency rTMS to the pelvic floor muscle representation in the contralesional primary motor cortex (M1) for 20 minutes thrice weekly. Sham-rTMS participants will receive the same parameters as the active-rTMS group, however, the coil will be rotated 90° away from the scalp. Fifteen active-rTMS participants will be invited for 45-60 minutes focus group discussions. The primary and secondary outcomes will be urinary incontinence severity and quality of life evaluated using the Overactive Bladder Symptom Score and Incontinence-Quality of life Questionnaire, respectively. Quality-adjusted life-years (QALY) will be the cost-effectiveness outcome. The EQ-5D-5L responses will estimate the gain or loss of QALY. A follow-up assessment will be conducted one-months post-intervention. The Client Service Receipt Inventory (CSRI) will be used to collect information on the whole range of services and support required by the study participants. Statistical analysis: Normality will be evaluated using Shapiro-Wilk test. To determine active-rTMS and sham-rTMS group differences, between-groups analysis of covariance (ANCOVA) will be conducted using R software. Bonferroni correction will be applied for multiple comparisons. Thematic analysis will be used for analysing the qualitative data. For the cost-effectiveness analysis, the unadjusted mean costs and cost differences between active-rTMS and the sham-rTMS group will be calculated.

Conditions

• Urgency Urinary Incontinence
• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Repetitive transcranial magnetic stimulation	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
DEVICE	Sham rTMS	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

Timeline

• Start date: 2022-11-09
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2022-09-27
• Last updated: 2024-05-03

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study