Overactive Bladder Clinical Trial
Official title:
A Mixed-methods Evaluation of the Clinical and Cost-effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neurogenic Overactive Bladder in Stroke
Verified date | September 2022 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 10, 2024 |
Est. primary completion date | January 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incontinence Quality-of-Life Questionnaire (I-QoL) | The I-QoL is reported to be a psychometrically robust incontinence-specific outcome measure for the evaluation of OAB quality of life. The I-QoL measure has 22 items subdivided into 3 subscale scores. The total scores is 100 with 0 representing worst quality of life and 100 means absence of problem (intraclass correlation coefficient [ICC] = 0.93). The measure is tested among Chinese population and found to be of sound psychometric properties; high internal consistency (Cronbach's a: 0.963; excellent test-retest reliability (ICC: 0.74-0.96, P<0.01) and acceptable construct validity. | Pre intervention, post intervention (4 weeks) and follow up (4 weeks) | |
Secondary | The Brief Resilience Scale | The Brief Resilience Scale has been reported to provide unique and critical information regarding "people coping with health-related stressors". Items 1, 3, and 5 on the scale are positively worded. In contrast, items 2, 4, and 6 are negatively worded. Resilience represents coping strategy of individuals to stressed environment and negative life events. The resilience is observed to be lacking in people with urinary incontinence of all age groups | Pre intervention, post intervention (4 weeks) and follow up (4 weeks) | |
Secondary | The 5-level EQ-5D (EQ-5D-5L) | The 5-level EQ-5D (EQ-5D-5L) version developed by the EuroQol Research Foundation will be used to estimate the Quality-adjusted life-years (QALY) gain or loss. | Pre intervention, post intervention (4 weeks) and follow up (4 weeks) |
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