---
title: Botulinum toxin reduces bladder overactivity
nct_id: NCT05997043
phase: EARLY_PHASE1
status: RECRUITING
sponsor: Zhujiang Hospital
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05997043"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05997043"
last_fetched: "2026-05-10T14:06:45.416Z"
source: "Parkinson's Pathways (curated)"
---
# Botulinum toxin reduces bladder overactivity

**Goal (in five words):** Botulinum toxin reduces bladder overactivity

**Official Title:** Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial

**Trial ID:** [NCT05997043](https://clinicaltrials.gov/study/NCT05997043)

## Key Facts

- **Phase:** EARLY_PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Zhujiang Hospital
- **Target Enrollment:** 60 participants
- **Start Date:** 2023-08-26
- **Completion Date:** 2024-07-01
- **Conditions:** Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
- **Interventions:** oral anti-Parkinson drugs and injection of botulinum toxin, oral anti-Parkinson's drugs
- **Intervention Types:** DRUG

## Summary For Families

They are testing whether injecting onabotulinumtoxinA into the bladder can safely reduce overactive bladder symptoms, like urgency, frequency, and leaking, in people with Parkinson's whose symptoms are not controlled by anticholinergic drugs. OnabotulinumtoxinA blocks acetylcholine release from nerves in the bladder wall, calming involuntary detrusor muscle contractions; the injections act locally in the bladder and do not change how levodopa works in the brain, and participants remain on their usual dopaminergic medications. Adults 25 to 80 with idiopathic Parkinson's and persistent overactive bladder despite anticholinergics can join, provided they can consent and are willing to use intermittent catheterization if needed, while people with significant urinary retention, glaucoma or myasthenia gravis, prior urinary botulinum treatment, dementia, or certain meds like anticoagulants or neuromuscular blockers are excluded.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

1. patients with idiopathic Parkinson's disease were diagnosed by experienced neurologists based on the diagnostic criteria of the International Motor Disorder Association.
2. PD patients with overactive bladder were observed by voiding diary for 3 days and evaluated by OABSS score.
3. Eligible males and females, aged between 25 and 80.
4. The patient was treated with dopaminergic drugs, and if there was an wearing-off phenomenon, it was evaluated during the turning-off period or without taking the drug (when the patient developed one of the symptoms in WOQ-19 \[13\] and the symptom improved after the next medication, it suggested that there was an end-of-dose phenomenon).
5. With a history of NDO ≥ 3 months, the symptoms of bladder overactivity were not fully controlled by anticholinergic drugs, which was defined as insufficient response after 4 weeks of treatment or unbearable side effects after 2 weeks of optimized dose treatment.
6. patients who took anticholinergic drugs at baseline must maintain a stable dose throughout the study, while those who did not take anticholinergic drugs could not take them during the study period.
7. if necessary, the patient must be willing to initiate intermittent catheterization (CIC).
8. the informed consent of the subject or his guardian has been obtained, and the informed consent of the clinical trial has been signed voluntarily.

Exclusion Criteria:

1\) Ultrasonography showed that the residual urine of bladder was larger than 10ml. 2) Patients with glaucoma and myasthenia gravis are not suitable for botulinum toxin.

3\) Indwelling catheter or intermittent catheterization (CIC) is needed to empty the bladder.

4\) Patients have been treated with botulinum toxin for any urinary disease. 5) People who are known to be allergic or allergic to drugs and their ingredients 6) Take drugs that interfere with neuromuscular transmission. 7) Receiving anticoagulant therapy. 8) There is infection at the injection site. 9)With dementia, Parkinson's dementia scale ≤ 73.5 at screening time \[15\] or with Parkinson's disease psychiatric disorder
```

## Locations (1)

- Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China _(23.1167, 113.2500)_
  - shuzhen zhu — (CONTACT) — 86-020-783071 — 453951712@qq.com

## Central Contacts

- Shuzhen Zhu, Doctor — (CONTACT) — 13719153239 — 453951712@qq.com
- Shujuan Yang — (CONTACT) — 13715657964 — ysjky266@163.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT05997043*  
*HTML version: https://parkinsonspathways.com/trial/NCT05997043*  
*Source data: https://clinicaltrials.gov/study/NCT05997043*