OBJECTIVE: To investigate the effect of long-term treatment with raloxifene on pelvic organ prolapse and urinary incontinence. METHODS: This was a case-control study in patients attending the Centre for Metabolic Bone Disease. Eighty-two women were included. The average age was 69 years (range 60-85 years). Thirty-nine women had taken raloxifene for an average of 55 +/- 25 months and 43 had taken bisphosphonates for an average of 41.96 +/- 15.93 months. The Prolapse Quality of Life (P-QOL), version 4 and Incontinence Impact questionnaire (IIQ-7) and Urogenital Distress Inventory, short form (UDI-6) were used to evaluate presence of pelvic organ prolapse and urinary incontinence. Women symptomatic with prolapse were offered a pelvic examination to define the type and severity of the prolapse. Women giving a history of urinary incontinence were offered urodynamic evaluation to establish the cause of the incontinence. The main outcome measures were prevalence and severity of pelvic organ prolapse and urinary incontinence and its impact on quality of life. RESULTS: Over 50% of the women complained of incontinence in both groups, 51% (22) of women taking raloxifene and 53% (28) of the controls. Prolapse was present in two women in the raloxifene group (5%) and six women (11%) in the control group. Urge incontinence was similar in both prevalence (15 vs. 21 women) and severity between cases and controls. Stress incontinence, on the contrary, had a similar prevalence (20 vs. 19 women) but was more severe in the controls (p = 0.004). There was no difference in mean scores of IIQ-7 and P-QOL for quality of life between cases and controls. CONCLUSIONS: Raloxifene taken long-term does not appear to adversely affect urinary incontinence or prolapse.