Botox versus extended release tolterodine in the management ofoveractive bladder in childre

Phase 1

• Conditions: Idiopathic Overactive Bladder; MedDRA version: 17.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2014-001068-36-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 <15mls / cm H2O

Bladder compliance is calculated by dividing the change in bladder volume (?V) by the change in detrusor pressure (?pdet) during that change in bladder volume: Compliance (ml/cm H20) = ?V/?pdet

Two standard points are taken for calculation of bladder compliance – first is detrusor pressure at start of bladder filling; second is detrusor pressure at cystometric capacity or immediately before the start of any detrusor contraction that causes significant leakage

•Detrusor overactivity is defined as bladder activity involving a rise of detrusor pressure of greater than 5 cm H2O above baseline

5.Ultrasound of the renal tract showing no structural abnormality, which could account for the symptoms.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

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