Objective: The aim of the study was to evaluate feasibility and results of ambulatory transurethral injections of Macroplastique using the system MIS under local anaesthesia, for treatment of female stress urinary incontinence.
Material and methods: We have performed a prospective multicentre study which has enrolled 20 patients between January 2003 and May 2004. Mean age was 72.8 ans (range 40 to 91). Preoperative inclusion criterias were positive stress test, 24 hours PAD test more than 10 g and post-void residual less than 100 ml. Urethral hypermobility was present in 8 patients (42.1%), and 3 patients was diagnosed as intrinsic sphincter deficiency (16.7%) on urodynamics examination. Pre and post-operative evaluation of urinary symptoms and quality of life were performed with the MHU score (Mesure du Handicap Urinaire), the Ditrovie score and the Contilife scale. The Macroplastique implant (Uroplasty) contains silicone and a bioabsorbable gel. Injections were perfomed under the mid-urethral mucosa (2.5 ml at 6 hours and 1.25 ml at 2 and 10 hours) using the system MIS (Uroplasty). No cystoscopy was required and the mean operative time was 15 minutes.
Results: The procedure was feasible under pure local anaesthesia in all cases. No intra-operative complications occurred. Postoperative complications had included 2/19 local pain (10.5%), 3/19 minimal urethrorrhagia (15.8%) and 6/19 urinary retentions (31.6%), which were treated by heterologous intermittent catheterization during 3 to 20 days. Eight patients returned home the same day (42.1%). The mean hospital stay was 2.3 days. Mean postoperative follow-up was 8.3 months (range 2.7 to 19.1). No patient required a second injection. Results had shown a 36.9% success rate (7/19), 52.6% improvement (10/19) and 10.5% failure (2/19). At follow-up, stress test was negative in 66.7% of patients (12/18) and PAD test was<10 g in 66.7% (10/15). Modifications on maximal flow rate were non significant after injections. Postoperatively, all urinary symptoms were improved except nocturia and voiding difficulties. Quality of life was improved on all parameters.
Conclusion: The surgical treatment of female stress urinary incontinence by transurethral injections of Macroplastique using the system MIS under local anaesthesia was feasible in all cases with a success or improvement rate of 89.5% at a mean follow-up of 8.3 months. Ambulatory treatment was compromised by the high rate of postoperative urinary retention (31.6%).