A randomized prospective study comparing new vaginal cone and FES-Biofeedback.

Several different methods of enhancing pelvic floor functions have been developed and modified. The aim of this study was to compare the efficacy of a new vaginal cone with conventional FES-Biofeedback therapy for female urinary incontinence, with respect to pelvic floor rehabilitation. One hundred and twenty patients, who required a non-surgical treatment for urinary incontinence, were divided randomly into two groups; (1) the Functional Electrical Stimulation (FES)- Biofeedback group (or BFB group) and (2) the new vaginal cone group (or cone group). For a period of six weeks, two training sessions each week were carried out on the BFB group. The new 150-gram dumbbell-shaped vaginal cone, made of fine ceramic material, was developed domestically. A therapist instructed patients in the cone group upon its use for pelvic floor exercise, and directed the exercise to be repeated at home daily; these patients had follow-up visits every week. Objective improvements were obvious in both groups. 88.3% and 91.6% of the cone and BFB groups showed an improvement after treatment, respectively. There was no significant difference in the improvement or dissatisfaction scores of the two groups. In conclusion, no significant differences in the therapeutic effects were observed between the FES- Biofeedback and the new vaginal cone groups. Considering improvements in the quality of life and objective symptoms, the therapeutic effects of the two techniques showed no significant differences. The new vaginal cone is relatively easy to use at home and aids in pelvic floor muscle exercises. Consequently, the new vaginal cone could be used as an alternative non-surgical treatment modality in female stress urinary incontinence.