None listed
Conditions
Brief summary
Women with severe urgency of micturition and urge incontinence, who have not responded to treatment with bladder training and appropriate tablets for two years, will be invited to join a study whereby they will receive a highly effective tablet (darifenicin) as well as either 6 weeks of antibiotics, or 6 weeks of placebo. Followup of clinical outcome will occur over 6 months.
Interventions
Antibiotic therapy will be as follows:
Amoxycillin 500mg and clavulanic acid 125mg twice daily for 2 weeks, oral capsule
then Norfloxacin 400mg twice daily for 2 weeks oral capsule
then Nitrofurantoin 100mg four times daily or 2 weeks, oral capsule
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients will be female, over 50 years of age who present with a main complaint of urge incontinence. Urodynamic testing will show a primary diagnosis of detrusor overactivity (DO). Patients will have failed to respond to bladder training with at least 2 anti-muscarinic therapeutic agents over 2 years. Participants must leak urine at least 1 episode per 3 days on frequency volume chart.
Exclusion criteria
a. Neuropathic DO (such as multiple sclerosis, spinal cord injury, Parkinsonism) b. Voiding dysfunction, defined as urinary flow rate less than 15 ml per sec for volume greater than 200ml with residual volume greater than 100ml c. Insufficient English language skills, or dementia, ie unable to complete questionnaires unaided. d. elevated creatinine, renal failure, e. allergy to more than penicillin
Outcome results
None listed