ISRCTN26091555
Completed
Not Applicable
Randomised trial of detrusor botulinum toxin injection compared to placebo in idiopathic detrusor overactivity
niversity Hospitals of Leicester NHS Trust (UK)0 sites240 target enrollmentMay 26, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Detrusor overactivity
- Sponsor
- niversity Hospitals of Leicester NHS Trust (UK)
- Enrollment
- 240
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 8 weeks of continued treatment with oral anticholinergic medication, with a screening Patient Global Impression of Improvement (PGI\-I) scale score of 'a little better' or 'worse'. This point of the scale represents a reduction of incontinence episode frequency of around 50% (Slack, unpublished data).
- •2\. 8 weeks of continued treatment, with a verbal response that the treatment has not provided acceptable improvement
- •3\. Treatment stopped because of side effects within 8 weeks
- •4\. Previous treatments stopped because of lack of efficacy, and currently receiving no treatment
- •Additionally, patients will report at least 8 voids per 24 hours, with at least 2 urgency episodes per 24 hours. Urgency episodes will be defined as those rated as 'moderate' or higher on the Urgency severity scale, and urge incontinence episodes will be defined as recorded leakage in association with an urgency episode.
Exclusion Criteria
- •1\. Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
- •2\. Patients with pre\-existing voiding dysfunction (flow rate less than 5th centile, or post void residual volume greater than 100 ml)
- •3\. Patients fulfilling the exclusion criteria for the licensed indications of botulinum toxin (myasethenia gravis and Eaton Lambert syndrome, or allergy to constituents of BOTOX® injection)
- •4\. Patients with co\-existing urodynamic stress incontinence
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Randomised trial of detrusor botulinum toxin injection (BOTOX®) compared to placebo in women with idiopathic detrusor overactivityDetrusor overactivity which is a disease of bladder function where unprovoked contractions of the detrusor muscle are generated during the storage phase of micturition. Symptoms include frequency, urgency, urge incontinence, nocturia. The first line treatment for this condition is with oral anticholinergic medication, which in many patients is ineffective.EUCTR2004-002981-39-GBniversity Hospitals of Leicester NHS Trust240
Recruiting
Phase 4
Botulinum toxin injections into the salivary glands to reduce drooling in childreExcessive drooling in children with neurological disordersNeurological - Other neurological disordersACTRN12605000379617Murdoch Children's Research Institute56
Completed
Not Applicable
The effects of botulinum toxin (BoNT) injection on sleep bruxism (SB) episodesKCT0004459Yonsei University Health System, Dental Hospital30
Completed
Not Applicable
Study of safety and duration of action of single dose (7.5 units) of botulinum toxin injection in patients with functional epiphora and proximal lacrimal drainage blockHealth Condition 1: H042- EpiphoraCTRI/2021/03/031793Dept of Ophthalmology Command Hospital Kolkata31
Recruiting
Phase 3
botulinum toxin A in emotional movements of the nostrilsrhinoplasty.Encounter for other plastic and reconstructive surgery following medical procedure or healed injuryZ42.8IRCT20230418057953N1Esfahan University of Medical Sciences60