Hypothesis / aims of study
Various adjunctive methods, especially biofeedback, have been applied to improve the outcomes of pelvic floor muscle exercise (PFME) in the treatment of stress urinary incontinence (SUI). Biofeedback is intended to perceive the proper PFM and to enhance training performance more efficiently by direct audiovisual stimuli. However, there have been controversies on the apparent effects of the combined biofeedback to PFME and this might be because previous studies had some methodologic drawbacks, such as differences in the PFME programs between groups and lack of treatment compliance or third-party assessment, and used various different devices. A recently developed portable perineometer (KegelQ) device has several characteristics different from existing ones. The silicone probe can expand evenly, not ovally in shape, enabling the patient to perform the exercise effectively no matter how deeply the probe is positioned in the vagina cavity, and the feedback can be provided more effectively by the actual pressure value (mmHg) and the change of the monitor color in addition to the graph (Fig. 1). We aimed to determine the effects of the addition of this new device to PFME on female SUI and feasibility of the clinical use.
Study design, materials and methods
From May 2016 to July 2017, 90 eligible women aged between 20 and 80 years with SUI symptoms for more than 3 months were randomly assigned to receive PFME, either alone (PFME only group, N = 45) or combined with KegelQ biofeedback (Biofeedback with KegelQ group, N = 45), in three teaching hospitals. All women showed the positive response on the Sandvik questionnaire item inquiring the presence of SUI symptoms during a recent week and had 2gm or more of urine leakage on 1-hr pad test at enrollment. After an explanation about the PFM anatomy and function, one physiotherapist per hospital, who had received training for standardization of PFME, taught participants to contract the PFM properly and assessed this by vaginal palpation. Then, participants were taught a predefined 12 week-exercise protocol, which consisted of repetitions of fast and sustained contractions for 9 minutes, to perform twice daily at home. In the Biofeedback group, participants were instructed to perform PFME with the KegelQ device in accordance with the same protocol embedded in the device. During study period, a physiotherapist contacted participants four times for monitoring treatment compliance and re-education of exercise, if needed. The primary outcome measure was an objective cure rate at 12 weeks, defined as less than 2gm of urine leakage on 1-hr pad test. Quality of life (QOL) and other measures of symptom severity at 12 weeks were evaluated as the secondary outcomes. The outcomes were measured by third parties who were blinded to group allocation and treatment sequence.
There were no significant differences in the clinicodemographic characteristics between both groups at baseline. Among 90 participants, 76 women completed the study (PFME only group 38, Biofeedback group 38). During the follow-up, the compliance of PFME at home was 76.5% and 73.2% in both groups. Within-group analyses demonstrated that both treatments significantly enhanced the status of urinary continence compared to the baseline except Sandvik frequency and severity index in the PFME only group. In the comparison of both groups, the objective cure rate at 12 weeks was 48.9% and 64.4% in the PFME only and Biofeedback group, respectively, but this was not significantly different (p = 0.136). Among the secondary outcomes, I-QOL score, PPBC score, Sandvik frequency and severity index, and changes of 1hr pad amount improved significantly more in the Biofeedback group compared to the PFME only group (Table 1). The strengths of the PFM at 4 & 12 weeks were also increased more in the Biofeedback group compared to the PFME only group. While patient age and baseline 1hr pad amount were related to the objective cure, the addition of a new device (OR 5.9, 95% CI 1.93-18.29) was the predictive factor for the meaningful improvement of total I-QOL score (≥6) at 12 weeks. Visual Analog Scale (0-10) on the inconvenience during the use of KegelQ was 1.8 (±1.8) and there were no reported adverse events related with the treatment in both groups.
Interpretation of results
In the present multicenter randomized trial, both 12 week-PFME with and without biofeedback using KegelQ device were effective for SUI symptoms and the objective cure rates at 12 weeks were not statistically different between groups. However, QOL and other measures of SUI symptom severity were significantly more enhanced in women with the use of a new device. These improvements may be derived from the degree of improvement of the strength of the PFM. A new device, the KegelQ, can be used as a useful adjunctive treatment to PFME.