CompletedPhase 2

Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients

Taiwan34 participantsStarted 2012-09

Plain-language summary

To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI) patients.

Who can participate

Age range

19 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults with age of 19 years old or above * Patients with chronic suprasacral cord SCI will be enrolled. * Patients will be proven having NDO by videourodynamic study during the screening period. * They also receive 99mTc-DTPA renal scanning for GFR at baseline. * Patients with NDO induced urinary incontinence who have adequate hand function or have a care-giver available for CIC, and the baseline total GFR of less than 80 mL/min are main inclusion criteria Exclusion Criteria: * Patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency * Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Net Change of the Urinary Distress Inventory (UDI-6)

Timeframe: Baseline and 12 months

Net Change of the Incontinence Impact Questionnaire (IIQ-7)

Timeframe: Baseline and 12 months

Net Change of the Quality of Life Index (QoL-I)

Timeframe: Baseline and 12 months

Trial details

NCT IDNCT01682603

SponsorBuddhist Tzu Chi General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2014-05-16

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range

19 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.