Idiopathic Overactive bladder syndrome MedDRA version: 8.0 Level: LLT Classification code 10029279
Conditions
Interventions
Trade Name: Dysport
Product Name: Dysport
Product Code: N/A
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Clostridium botulinum type A toxin - haemagglutinin complex
Concentration nu
Sponsors
R and D Department, Cardiff and the Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 clinical diagnosis of Overactive Bladder Syndrome without any neurogenic cause, with or without evidence of detrusor overactivity on conventional urodynamic assessment. 4. The patient must have Overactive Bladder Syndrome resistant to anticholinergic medication, or suffer unacceptable side effects from anticholinergic therapy. 5. The patient must be fit for flexible cystoscopy under local anaesthetic. 6. The patient must be willing and able to use clean intermittent self-catheterisation (CISC) if this becomes necessary. 7. The patient must be competent to give informed consent. 8. 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
Exclusion criteria: 1. The patient has significant coexisting genuine stress incontinence. 2. The patient is suffering from any severe concomitant medical illness, or has significantly reduced renal or hepatic function. 3. The patient has concurrent other bladder pathology. 4. The patient has an indwelling catheter. 5. The patient has coexisting myaesthenia gravis. 6. 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). 7. The patient has a history of blood clotting disorders, or is on warfarin. 8. 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 of the study assessments. 9. The patient has any contraindication to the use of Botulinum toxin (any serotype). 10. The patient has a known allergy or hypersensitivity to clostridium botulinum neurotoxin complex or to any of the excipients. 11. 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. 12. The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy. 13. The patient is receiving anticholinergic medication for which the dose has not been stable for at least 12 weeks prior to the baseline visit. 14. 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. 15. 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. 16. The patient has previously entered this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in the quality of life and symptomatology score (as assessed using the scoring in the King’s Health Questionnaire (KHQ)) 6 Weeks after treatment with Botulin Toxin type A in comparison with the baseline score.;Secondary Objective: To assess the change in the quality of life and symptomatology score (as assessed using the scoring in the KHQ) following treatment with Botulinum toxin Type A at all other time points in comparison with the baseline score. To assess the change in urodynamic parameters (volume at first detrusor contraction, detrusor compliance, maximum cystometric bladder capacity and post-void residual volume (as measured by ultrasound of the bladder). To assess the change in patient satisfaction with treatment (as assessed using the numerical rating scale). To assess the change in past-24 hour continence check findings. To assess the changes in bladder diary parameters. To compare the anticholinergic medication requirement at each assessment time point in comparison to the baseline visit. To assess the safety of treatment with Botulinum toxin Type A .;Primary end point(s): Change in quality of life and symptomatology score (as assessed using the scoring in the ten domains of the King’s health questionnaire (KHQ)) at Week 6 in comparison with the baseline score. | — |
Countries
United Kingdom
Outcome results
None listed