A Prospective, Single-Arm, Open-label Study to Investigate the Efficacy and Safety of Intravesical Injection of Botulinum Toxin Type-A (750 Units Dysport®) for the Management of Neurogenic Detrusor Overactivity. - Botulinum Toxin for the Management of Neurogenic Detrusor Overactivity

Phase 1

• Conditions: eurogenic detrusor overactivity; MedDRA version: 8.0 Level: LLT Classification code 10029279

• Registration Number: EUCTR2005-004996-40-GB
• Lead Sponsor: R and D Department, Cardiff and the Vale NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-13
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. The patient must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
2. The patient must be between 18 and 75 years of age inclusive.
3. The patient must have a diagnosis of a neurological problem of >1 yr duration.
4. The patient must have urodynamically proven detrusor overactivity or low compliant bladder.
5. The patient must have urinary symptoms resistant to anticholinergic medication, or suffer unacceptable side effects from anticholinergic therapy.
6. The patient must be fit for flexible cystoscopy under local anaesthetic.
7. The patient must be willing and able to use clean intermittent self-catheterisation (CISC) if this becomes necessary except those patients who have an indwelling catheter.
8. The patient must be competent to give informed consent.
9. The patient must be able and willing to comply with the requirements of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The patient is suffering from any severe concomitant medical illness, or has significantly reduced renal or hepatic function.
2. The patient has concurrent other bladder pathology.
3. The patient has coexisting myasthenia gravis.
4. The patient has a persistent urinary infection or un-investigated haematuria (if patients are diagnosed with a urinary tract infection at screening, part 2 of the screening assessments will be postponed until the infection had resolved).
5. The patient has a history of blood clotting disorders or is on warfarin.
6. The patient has any other serious illness or medical condition that in the opinion of the investigator would jeopardise the efficacy or safety of this treatment or any of the study assessments.
7. The patient has any contraindication to the use of Botulinum toxin (any serotype).
8. The patient has a known allergy or hypersensitivity to clostridium botulinum neurotoxin complex or to any of the excipients.
9. The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile or < 1 year post-last menstrual period) must have a negative pregnancy test on the day of injection.
10. The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy.
11. The patient is currently treated with, or has been treated during the week prior to the study with medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics.
12. The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
13. The patient has previously entered this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified