Idiopathic Overactive Bladder MedDRA version: 17.0 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Botox
Product Name: Onabotulinum toxin A
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Botulinum toxin type A (from Clostridium botulinum)
Concentration unit: IU internati
Sponsors
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of both sexes between the age of 7 and 16 years inclusive, with clinical symptoms of IOAB. IOAB clinical symptoms are urgency, wetting episodes, increased frequency of micturition. 2. Symptoms must include episodes of daytime urinary incontinence. Symptomatic patients are defined as those who have symptoms of overactive bladder with at least two episodes of daytime wetting per week despite medication. 3. Incomplete resolution of symptoms after bladder training and at least six months of anticholinergic therapy (or at least four months duration of therapy at study registration). Anticholinergic therapy may comprise of Oxybutynin, Solifenacin or Tolterodine. Incomplete resolution is defined as per ICCS definition as no and partial response (less than 50% and 50 - 90% improvement respectively). 4. Urodynamic studies demonstrating either detrusor over activity and/or reduced bladder compliance and/or reduced bladder capacity. • Reduced bladder capacity is defined as bladder capacity smaller than 70% of expected capacity. Expected bladder capacity (mls) is calculated as: (age{in years} +1) X 30 • Reduced bladder compliance is defined as =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Recurrent urinary tract infection (UTI) (more than two documented episodes in the last three months) not controlled with antibiotic prophylaxis. 2. The presence of a neurological pathology, which could account for incontinence, on physical examination. 3. Evidence of significant dysfunctional voiding. 4. Post-void residuals greater than 20% of predicted bladder capacity. 5. Previous treatment with Botox® 6. Allergy to Botox® or Tolterodine 7. Positive pregnancy test in post menarchal girls 8. Myasthenia gravis 9. Kidney transplant 10. Abnormal liver function (liver function tests > 3 times upper limit of laboratory normal range) 11. Severe ulcerative colitis, toxic megacolon, gastro-intestinal obstruction or intestinal atony.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): We will collect the following information to allow us to plan the main trial: 1. Eligibility rate of the patients screened - how many meet the eligibility criteria. 2. Recruitment rate of the eligible patients - how many consent to take part in the study. 3. Acceptability of randomisation to those patients consenting - how many are actually randomised, and of those randomised how many receive the treatment allocated. 4. Primary outcome data for the power calculation. 5. Loss to follow up rate of the patients randomised - how many children will continue to be willing to participate throughout the study 6. Acceptability and suitability of urodynamic study to assess secondary outcome measures The pilot study will be conducted with the same protocol as is intended for the full trial. Our primary outcome measure for the proposed RCT will be the mean number of episodes of urinary incontinence per day. This information will be derived from the data recorded in the bladder diary. No bladder diary has been validated for this purpose in the literature although the standardisation committee of the International Children's Continence Society(ICCS) stipulates what data should be collected in a bladder diary and for how long. We will therefore assess whether patients complete the data collection tool (bladder diary) with sufficient detail and accuracy to allow robust reporting of the primary outcome measure. The secondary outcome measures for the proposed RCT following this pilot/feasibility study will be follows: Urodynamic study data at six weeks Bladder diary analysis at six weeks, three and six months Post-void residual urine volume at 3 and 6 months Quality of life scores (PedsQL / PinQ) at six weeks, three and six months Adverse effects ;Timepoint(s) of evaluation of this end point: 22.5 months from commencement of study;Main Objective: The principle objective of the pilot study is to ensure that a full randomised control t | — |
Countries
United Kingdom
Contacts
Public ContactLynne Webster
Central Manchester University Hospitals NHS Foundation Trust
Outcome results
None listed