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Effect of antibiotics on urine leakage in women with refractory detrusor overactivity: A phase IIb randomized trial
Author(s) -
Chen Zhuoran,
Moore Kate H.,
Mansfield Kylie J.,
Ognenovska Samantha,
Allen Wendy,
Parkin Katrina,
Mukerjee Chinmoy,
Aryal Nanda R.,
Gebski Val
Publication year - 2021
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.24525
Subject(s) - medicine , placebo , refractory (planetary science) , randomized controlled trial , antibiotics , urinary incontinence , clinical trial , anticholinergic , urine , urology , urinary system , surgery , physics , alternative medicine , pathology , astrobiology , microbiology and biotechnology , biology
Aim Because bacterial cystitis is common in women with refractory detrusor overactivity, the aim was to compare the efficacy of 6 weeks of rotating antibiotics versus placebo, in conjunction with an anticholinergic, in controlling the symptoms of urge incontinence. Methods In a multicenter phase IIb double‐blinded randomized placebo‐controlled trial, women with urodynamically proven refractory detrusor overactivity were randomized in a 2:1 ratio of antibiotics versus placebo for 6 weeks, in addition to darifenacin for 6 months. Any woman with disabling cystitis symptoms was given appropriate antibiotics (“clinical override”). The primary outcome was the degree of urge incontinence change at 6 weeks and 6 months on 24‐h pad test. Secondary outcomes were changes in leaks and voids per day measured on 3‐day bladder diary and quality of life measures. Microbiological data were collected at all visits. Results Although 278 women were screened, only 36 were randomized and 33 (91.7%) completed the trial. Leakage on 24‐h pad test decreased at 6 months by 75 g in patients receiving antibiotics versus 35 g in placebo. Cure of urge incontinence occurred at 6 months in 10/21 (48%) of antibiotics versus 2/12 (17%) of placebo. Clinical override, necessitating treatment of cystitis, occurred in 41.6% of placebo versus 16.7% of the antibiotic group by 6 months. Conclusion Despite the small sample size, the study showed a significant reduction in pad leakage and leaks per day over 24 h in the active treatment group over a 6‐month period. Nearly half of patients on placebo had disabling urinary tract infection symptoms that required clinical override treatment.