oral anti-Parkinson drugs and inje… for Parkinson's (NCT05997043)
Reduce bladder urgency and frequency
- Trial ID
- NCT05997043
- Official Title
- Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial
- Goal
- Reduce bladder urgency and frequency
- Phase
- EARLY_PHASE1
- Status
- UNKNOWN
- Sponsor
- Zhujiang Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
- Interventions
- oral anti-Parkinson drugs and injection of botulinum toxin, oral anti-Parkinson's drugs
Summary For Families
The goal is to see if a low dose injection of botulinum toxin into the bladder muscle can safely ease overactive bladder symptoms in people with Parkinson's, like sudden urges to pee, going often, and waking at night. The plan is to randomly assign participants to keep their usual Parkinson's medicines and either get the bladder injection plus medicines or stay on medicines alone, building on prior use of a 100-unit dose but testing a lower dose to better measure benefits and side effects. They are enrolling people aged 25 to 80 with diagnosed Parkinson's whose overactive bladder is not fully helped by standard bladder medicines, who are on Parkinson's drugs, and who do not have large leftover urine or conditions that make botulinum toxin unsafe, such as glaucoma or myasthenia gravis, and who can consider short-term catheter use if needed.
Locations
- Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying oral anti-Parkinson drugs and injection of botulinum toxin. The goal is to see if a low dose injection of botulinum toxin into the bladder muscle can safely ease overactive bladder symptoms in people with Parkinson's, like sudden urges to pee, going often, and waking at night. The plan is to randomly assign participants to keep their usual Parkinson's medicines and either get the bladder injection plus medicines or stay on medicines alone, building on prior use of a 100-unit dose but testing a lower dose to better measure benefits and side effects. They are enrolling people aged 25 to 80 with diagnosed Parkinson's whose overactive bladder is not fully helped by standard bladder medicines, who are on Parkinson's drugs, and who do not have large leftover urine or conditions that make botulinum toxin unsafe, such as glaucoma or myasthenia gravis, and who can consider short-term catheter use if needed.
- Who can participate?
- Participants must be between 25 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 10 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive). Confirm the full schedule with the study coordinator.