RecruitingPhase 4ACTRN12613000285752

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


Sponsor

University of New South Wales

Enrollment

166 participants

Start Date

Jun 1, 2014

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 50 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

Urge incontinence — when you feel a sudden, strong need to urinate and cannot always hold it — is a very distressing problem for many older women. This trial is for women whose urgency and leakage has not improved despite trying bladder training and at least two different bladder medications over two years. The study will test whether adding a 6-week course of antibiotics to a commonly used bladder medication (darifenacin) gives better long-term control than the medication alone with a placebo. You may be eligible if: - You are a woman aged 50 or older - Your main problem is urge incontinence - Urodynamic testing has confirmed your bladder is overactive - You have tried at least 2 anti-muscarinic medications over 2 years without enough improvement - You leak urine at least once every 3 days You may NOT be eligible if: - Your overactive bladder is caused by a neurological condition (e.g. multiple sclerosis, spinal cord injury) - You have significant difficulty emptying your bladder - You cannot complete questionnaires due to language difficulties or dementia - You have elevated creatinine or kidney failure - You are allergic to more than penicillin Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Nitrofurant

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


Locations(2)

St George Hospital - Kogarah

NSW, Australia

Wollongong Hospital - Wollongong

NSW, Australia

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ACTRN12613000285752