A Randomized Prospective Study Comparing the Outcome of the New Vaginal Cone and Functional Electrical Stimulation(FES)-Biofeedback in Female Stress Urinary Incontinence

ABSTRACT

INTRODUCTION: Several different methods of enhancing pelvic floor functions have been developed and modified. The aim of this investigation was to compare the usage of a new vaginal cone (double cone) with conventional FES-Biofeedback therapy for female urinary incontinence cases with respect to the effects on pelvic floor rehabilitation. MATERIALS AND METHODS: It was performed on a multi-center based study. One hundred patients, who desired a non-surgical treatment for their urinary incontinence, were divided into two groups randomly. They were (1) the FES-Biofeedback group (or BFB group); and (2) the new vaginal cone group (or cone group). For a period of six weeks, two sessions each week were carried out for the BFB group. The new 150-gram dumbbell- shaped vaginal cone, made up of fine ceramics material, was developed domestically. A therapist instructed these patients in the cone group for using the new cone for pelvic floor exercises and directed them to repeat the exercises at home daily, as these patients had follow-up visits every week. RESULTS: Objective improvements were obvious in both of these groups. 88% of the cone group and 92% of the BFB group showed an improvement after treatment. There was no significant difference in the improvement of dissatisfaction scores between the two groups. CONCLUSION: 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 another treatment modality in non-surgical approaches to female stress urinary incontinence.