A Beraru1, S Droupy2, L Wagner2, L Soustelle2, C Muyschondt2, K Ben Naoum2, P Grés2, M Boukaram2, P Costa2. 1. Service d'urologie et d'andrologie, hôpital universitaire Caremeau, CHU de Nîmes, place du Professeur-R.-Debré, 30029 Nîmes cedex 9, France. Electronic address: alexberaru@gmail.com. 2. Service d'urologie et d'andrologie, hôpital universitaire Caremeau, CHU de Nîmes, place du Professeur-R.-Debré, 30029 Nîmes cedex 9, France.
Abstract
INTRODUCTION: This study was carried out to evaluate the efficacy of periurethral injection of polyacrylamide hydrogel (PAHG, Bulkamid(®), Ethicon) for the treatment of female stress urinary incontinence (SUI). METHODS: Single-center prospective study: periurethral injection of Bulkamid(®) was performed in 80 patients with severe urinary incontinence between June 2010 and October 2011. The evaluation of the impact on quality of life was carried out using the Patient Global Impression of Severity (PGI-S), the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and Patient Global Impression of Improvement (PGI-I) before and after treatment. RESULTS: With a mean follow-up of 18.6 ± 5.3 months, 60% of patients had improved. For 30/74 (40%) there was no improvement and no patient had worsening of PGI-I after injection. Before surgery, 55.4% of patients considered their condition as severe (PGI-S). After injecting 21/74 (28%) and 11/74 (15%) considered it normal and severe (zero leakage). The ICIQ -SF score increased from 17 ± 2.84 before injection to 13 ± 5.52 after surgery, with a significant 30% decrease (P<0.00001). The reinjection rate was 29%. The complication rate was 16% (17/108): 11 cases of transient postoperative retention, 2 cases of cystitis, dysuria four episodes. No abscess or infection at the injection site, no specific complication to the product used. CONCLUSION: With an (PGI-I) improvement rate of 60 and 15% of patients without leakage (PGI-S/ICIQ), periurethral injection of Bulkamid(®) is an effective and safe treatment option for women with a severe urinary incontinence especially in therapeutic failure. LEVEL OF PROOF: 4.
INTRODUCTION: This study was carried out to evaluate the efficacy of periurethral injection of polyacrylamide hydrogel (PAHG, Bulkamid(®), Ethicon) for the treatment of female stress urinary incontinence (SUI). METHODS: Single-center prospective study: periurethral injection of Bulkamid(®) was performed in 80 patients with severe urinary incontinence between June 2010 and October 2011. The evaluation of the impact on quality of life was carried out using the Patient Global Impression of Severity (PGI-S), the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and Patient Global Impression of Improvement (PGI-I) before and after treatment. RESULTS: With a mean follow-up of 18.6 ± 5.3 months, 60% of patients had improved. For 30/74 (40%) there was no improvement and no patient had worsening of PGI-I after injection. Before surgery, 55.4% of patients considered their condition as severe (PGI-S). After injecting 21/74 (28%) and 11/74 (15%) considered it normal and severe (zero leakage). The ICIQ -SF score increased from 17 ± 2.84 before injection to 13 ± 5.52 after surgery, with a significant 30% decrease (P<0.00001). The reinjection rate was 29%. The complication rate was 16% (17/108): 11 cases of transient postoperative retention, 2 cases of cystitis, dysuria four episodes. No abscess or infection at the injection site, no specific complication to the product used. CONCLUSION: With an (PGI-I) improvement rate of 60 and 15% of patients without leakage (PGI-S/ICIQ), periurethral injection of Bulkamid(®) is an effective and safe treatment option for women with a severe urinary incontinence especially in therapeutic failure. LEVEL OF PROOF: 4.