The object of this review was to assess the efficacy and safety of urethral bulking agents (UBA), principally Macroplastique and Bulkamid, in the treatment of female stress urinary incontinence (SUI). Methods MEDLINE® and EMBASE® databases were systematically searched up to June 2016. Year of publication, study type, outcome measures, urodynamics before and after the procedure, number of participants, procedure complications, proportion requiring repeat injections or surgical procedures, frequency of follow-up, and results were analysed. Results The use of Bulkamid and Macroplastique for the treatment of female SUI was described in 26 studies. Studies used modalities including the visual analogue scale, Likert scale, International Consultation on Incontinence Modular Questionnaire (ICIQ), Patient Global Improvement Questionnaire (PGIQ) and Incontinence Impact Questionnaire (IIQ) and showed success rates ranging from 66% to 89.7% at 12 months follow-up. Objective improvements in patient symptoms were measured using urodynamics, 24-h pad tests, cough tests and voiding diaries. Studies showed variable objective success rates ranging from 25.4% to 73.3%. Objective findings for UBAs remain less well documented than those for the midurethral sling procedure. Conclusions There are a range of complications associated with UBAs, the most common being urinary tract infection.

However, it remains a very well tolerated procedure in the majority of patients. UBAs should be considered as an alternative in patients unsuitable for more invasive procedures and those willing to accept the need for repeat injections. The majority of the literature focuses on subjective improvement measures rather than objective improvement measures. Further randomized controlled trials directly comparing UBAs are required to indicate the most effective agent.