PURPOSE: To investigate the effectiveness and safety of periurethral injections (PIs) of polyacrylamide hydrogel (PAHG, Bulkamid(®)) for the treatment of female stress urinary incontinence (SUI). METHODS: This double-centre prospective study included 82 female patients with SUI who were treated with PIs of PAHG between January 2008 and December 2010 in outpatient setting. The International Consultation on Incontinence Questionnaire short form (ICIQ-SF) and the Patient Global Improvement Impression (PGI-I) were used to assess incontinence and patient satisfaction after treatment. The impact of incontinence on quality of life (QoL) was investigated using the Incontinence Impact Questionnaire (IIQ-7). RESULTS: All patients were discharged on the same day of treatment and there was no intraoperative complication. At 1-year follow-up, the efficacy of PIs of PAHG (subjective success rate) was 74.4 %. The subjective responder rate was 86.6 %, 8.5 % of patients had no change and no patient reported worsening of symptoms. The mean number of episodes of urine leakage/24 h and the mean leakage/24 h significantly decreased after treatment. At 1-year follow-up, the IIQ-7 results were significantly improved compared with baseline. 25.6 % of patients had adverse events (mainly urinary tract infections and injection site pain). CONCLUSION: This study demonstrates that PIs of PAHG are effective and safe and cause significant improvement of the QoL at 1-year follow-up. PIs of PAHG can be safely performed in an ambulatory setting and patients may be discharged on the day of the procedure.
PURPOSE: To investigate the effectiveness and safety of periurethral injections (PIs) of polyacrylamide hydrogel (PAHG, Bulkamid(®)) for the treatment of female stress urinary incontinence (SUI). METHODS: This double-centre prospective study included 82 female patients with SUI who were treated with PIs of PAHG between January 2008 and December 2010 in outpatient setting. The International Consultation on Incontinence Questionnaire short form (ICIQ-SF) and the Patient Global Improvement Impression (PGI-I) were used to assess incontinence and patient satisfaction after treatment. The impact of incontinence on quality of life (QoL) was investigated using the Incontinence Impact Questionnaire (IIQ-7). RESULTS: All patients were discharged on the same day of treatment and there was no intraoperative complication. At 1-year follow-up, the efficacy of PIs of PAHG (subjective success rate) was 74.4 %. The subjective responder rate was 86.6 %, 8.5 % of patients had no change and no patient reported worsening of symptoms. The mean number of episodes of urine leakage/24 h and the mean leakage/24 h significantly decreased after treatment. At 1-year follow-up, the IIQ-7 results were significantly improved compared with baseline. 25.6 % of patients had adverse events (mainly urinary tract infections and injection site pain). CONCLUSION: This study demonstrates that PIs of PAHG are effective and safe and cause significant improvement of the QoL at 1-year follow-up. PIs of PAHG can be safely performed in an ambulatory setting and patients may be discharged on the day of the procedure.