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Trial from ANZCTR

Refractory Urge Incontinence in Women: a randomized placebo controlled trial of antibiotic therapy for cystitis erradication

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 22/5/2014)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID


Date registered

11 March 2013

Health condition

detrusor overactivity, urge incontinence, bacterial cystitis

Recruitment countries


Recruitment site location(s) (State)

New South Wales

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

01 June 2014

Ethics application status


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.


Key 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.

Minimum age

50 Years

Maximum age

90 Years



Key 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

Contact details and further information

Primary Sponsor

Type: University
Name: University of New South Wales
Address: University of New South Wales
Barker Street
Kensington New South Wales 2052
Country: Australia

Contact person for information and recruitment

Ms Wendy Allen
Continence Research Nurse
Pelvic Floor Unit
St George Hospital
Cnr Belgrave & South Sts