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.

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

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.