THE USABILITY OF PELVEXISER URO-STOP DEVICE

Abstract

Background:The biofeedback is used as an adjunct to pelvic floor muscle training (PFMT). It includes primarily the vaginal and anal surface electromyography and urethral and vaginal squeeze pressure measurements. However, several systematic reviews concluded that combined therapy seems to have no additional benefit compared to PFMT alone, but might be useful for some women to learn how to perform a correct PFM contraction and to increase motiva- tion. The aim of the study was identify the degree of usability of the Pelvexiser URO-STOP device in raising the awareness and coordinated PFM function, self-learning of correct voluntary PFM contraction and the performance of PFM.

Methods: Women between 18 and 65 years of age were invited to participate in the study. The par- ticipants presented with PFM dysfunction which was defined as clinically present urinary incontinence and weak PFM or absence of PFM contraction, respectively. They were referred to physiotherapy by a specialist in gynaecology and obstetrics. In the first physiotherapy session the participants filled in a preliminary questionnaire and received detailed written and verbal instructions on the use of Pelvexiser URO-STOP device (the device measures the change in vaginal squeeze pressure). The PFM function was assessed by visual observation and vaginal palpation. During the assessment the participants were offered no feedback on the correctness/incorrectness of PFM contraction performance. The PFM function was assessed by a modified Oxford scale. The participants used the device for four weeks by themselves at home. After this period they filled in a final questionnaire and their PFM function was re-assessed. Descriptive statistics were used to summarize and analyze the data from the questionnaires, PFMT diaries and the PFM function assessment sheets.

Results: Included in the study were 8 female subjects (age 41 (±13) experiencing PFM dysfunction who had given written consent to participate in the study. Prior to the study, seven women were able to perform a correct voluntary PFM contraction. At one woman no voluntary contraction was detected even after having used the device. Before the use of the device, the attempts to contract the PFM were accompanied by more than three substitute movements at one half of the participants (breath holding, enhanced inhaling, contraction of outer abdominal muscles and hip adductor muscles). After the use of the device the type and frequency of the substitute movements were not decreased. The PFM function improved at all women after the use of the device but none was capable to perform the PFMT in the full range prescribed. According to the participants the device was simple to use but half of them would not be able to employ it without prior instruction offered by a physiotherapist. One woman reported that the hygienic maintenance of the device was difficult and two of them commented on the size and hardness of the vaginal probe.

Conclusions: The results obtained indicate that the Pelvexiser URO-STOP device was not effective in learning the correct PFM contraction. However, it can present a useful adjunct to PFMT to increase the PFM performance. A pre-condition to achieve the desired effect is an exact preliminary assessment of the function of PFM, individual training of the correct voluntary PFM contraction preceded by a healthcare worker’s instruction on the correct use of the device.