EUCTR2006-000129-76-GB
Active, not recruiting
Phase 1
Botulinum toxin-A in Sensory Urgency - BTXSENS
Guy's & St Thomas' NHS Foundation Trust0 sites64 target enrollmentApril 17, 2007
ConditionsSensory Urinary Urgency. This is a condition where patients have urinary urgency (sudden desire to urinate which cannot be deferred) /- urge incontinence (urine leakage) and usually is accompanied by frequency (frequent passage of urineusually > 8/day)and nocturia (passing urine at night ie getting up from sleep). No abnormal bladder muscle overactivity, however, is present.MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sensory Urinary Urgency. This is a condition where patients have urinary urgency (sudden desire to urinate which cannot be deferred) /- urge incontinence (urine leakage) and usually is accompanied by frequency (frequent passage of urine
- Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent to participate
- •Male and females
- •18\-80 years of age
- •Sensory urgency as defined by the investigators ie symptoms of overactive bladder with no evidence of detrusor overactivity on urodynamics
- •Refractory to anticholinergics
- •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
Exclusion Criteria
- •Pregnancy or planned pregnancy in the next year
- •Breast feeding
- •Painful bladder syndrome or interstitial cystitis
- •Evidence of significant outflow obstruction
- •Indwelling catheter
- •Previous bladder surgery eg augmentation cystoplasty
- •Previous urological use of botulinum toxin
- •Other bladder pathology eg tumours, active infection
- •Current anticoagulation treatment eg heparin, warfarin
Outcomes
Primary Outcomes
Not specified
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