Intrasphincteric autologous myoblast injections with electrical stimulation for stress urinary incontinence

Abstract

ObjectiveTo assess the feasibility and safety of ultrasound-guided autologous myoblast injections into the external urethral sphincter followed by electrical stimulation (ES) as a possible 2-step treatment for stress urinary incontinence (SUI). MethodsAutologous myoblasts isolated from a biceps muscle sample were injected under transurethral ultrasound guidance into the external urethral sphincter of 38 female patients. The patients also underwent ES postoperatively to enhance cell integration. Treatment feasibility, as well as possible intraoperative and postoperative complications, was assessed 6weeks after the injections. Additionally, the effects of the myoblast injections followed by an ES cycle were compared to those of a preoperative ES cycle undergone by the same patients. ResultsNo serious adverse events or complications were noted and the procedure was well tolerated. Compared with the objective and subjective measurements collected after the preoperative ES cycle, the corresponding measurements obtained 6weeks postoperatively, after the completion of a second ES cycle, indicated considerable improvement. The results to the stress test were negative for 29 (78.4%) of the patients, 5 (13.5%) considered their SUI cured, and 29 (78.4%) reported improvement. ConclusionIntrasphincteric autologous myoblast injections followed by ES is minimally invasive and feasible, and safely produced promising initial results.EU Clinical Trials EudraCT No. 2009-012389-30ClinicalTrials.gov identifier: NCT01355133