Abstract
Introduction and hypothesis
The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence.
Methods
This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings.
Results
The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months’ follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication.
Conclusions
Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.
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Abbreviations
- MUI:
-
Mixed urinary incontinence
- NFOG:
-
Nordic Federation of Obstetrics and Gynecology
- SIMS:
-
Single-incision mid-urethral slings
- SMUS:
-
Standard mid-urethral slings
- SUI:
-
Stress urinary incontinence
- UTI:
-
Urinary tract infection
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Acknowledgements
We thank Katarina von Bothmer Östling from Halmstad Hospital in Sweden, Anja Holstad from Gjøvik Hospital in Norway, Claes Magnusson from Sahlgrenska University Hospital in Sweden, Memona Majida from Ahus University Hospital in Norway, and Constanze Merkel from Regional Hospital of Northern Jutland in Denmark for their vital contributions to the development of this project. We also thank all the women who participated in this study and shared their experiences.
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The trial was registered at ClinicalTrials.gov: NCT01754558. URL: clinicaltrials.gov/ct2/show/NCT01754558?term=NCT01754558&rank=1
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Rudnicki, M., Jakobsson, U. & Teleman, P. Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial. Int Urogynecol J 31, 1545–1550 (2020). https://doi.org/10.1007/s00192-019-04156-9
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DOI: https://doi.org/10.1007/s00192-019-04156-9