Commented Abstracts

A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence.
BJU Int. 2009 Jan 14.

Peter J. Gilling, Liam C. Wilson, Andre M. Westenberg, William J. McAllister*,
Katie M. Kennett, Christopher M. Frampton † , Deborah F. Bell,
Patricia M. Wrigley and Mark R. Fraundorfer
Departments of Urology and Physiotherapy, Tauranga Hospital, Tauranga, and *Broomfield Hospital,
Chelmsford,England, and †Department of Biostatistics, Christchurch School of Medicine, Christchurch, New Zealand

OBJECTIVE: To compare the efficacy of extracorporeal electromagnetic stimulation (ES) of the pelvic floor for treating stress urinary incontinence (SUI) vs sham ES.

PATIENTS AND METHODS: In all, 70 women with urodynamically confirmed SUI were randomized to receive active (35) or sham (35) ES. The NeoControl chair (NeoTonus, Marietta, GA, USA) was used, and treatment consisted of three sessions per week for 6 weeks. Data were collected before and after treatment on all women, including a 20-min provocative pad-test with a predetermined bladder volume (primary outcome measure), a 3-day bladder diary and 24 h pad-test. Circumvaginal muscle (CVM) rating score, perineometry using two separate instruments and video-urodynamics were also used, and the Urinary Incontinence Quality of Life Scale (I-QOL) and King's Health Questionnaires. Patients were fully re-evaluated 8 weeks after treatment, and the bladder diary, pad-test and questionnaires were repeated at 6 months. The urotherapist and physician were unaware to which treatment group the patient was assigned.

RESULTS: In the overall group of 70 patients there were significant improvements in each of the primary and secondary outcome measures at 8 weeks. There were also significant improvements in primary and secondary outcome measures in the active treatment group when compared with baseline measures. At 8 weeks, there were improvements in the mean (sd) values for the 20-min pad-test, of 39.5 (5.1) vs 19.4 (4.6) g (P < 0.001); the 24-h pad-test, of 24.0 (4.7) vs 10.1 (3.1) g (P < 0.01); the number of pads/day, of 0.9 (0.1) vs 0.6 (0.1) (P < 0.01), the I-QOL score, of 63.7 (2.8) vs 71.2 (3.3) (P < 0.001); and King's Health Questionnaire score, of 9.6 (0.8) vs 6.9 (0.7) (P < 0.001). However, these improvements were not statistically significant when compared with the sham-treatment group. In those patients on active treatment who had a poor pelvic floor contraction at the initial assessment (defined by the CVM score and perineometry), there was a significant reduction (P < 0.05) in the 20-min pad-test leakage when compared with the sham-treatment group.

CONCLUSIONS: ES was no more effective overall than sham treatment in this patient group. However, in those women who were unable to generate adequate pelvic floor muscle contractions, there was an objective improvement in provocative pad testing when compared to sham treatment.

KEYWORDS: stress incontinence, conservative management, electromagnetic stimulation

Editor’s comment

The conservative treatment for stress urinary incontinence has been considered the first treatment option, especially in cases of mild to moderate UI. The major treatment modality is physical therapy, strengthening and training the pelvic floor muscles (PFM). Exercises can strengthen the urethral closure process, pelvic organ support and PFM contraction at the right time and with the proper magnitude to prevent urinary loss, pressing the urethra against the pubic bone. Therefore, the treatment approach aims at strengthening the muscle groups and to educate the patient on how to use them strategically in stress or urgency situations. Notwithstanding, we are yet to identify and standardize the best treatment protocol or to find reliable predictive factors to achieve positive results with the treatment. In general, the use of electrostimulation in order to improve results, in single treatments or in combination with exercises, have resulted in conflicting subjective and objective results; however, in properly carried out studies, when benefits were seen, they were not outstanding. The use of a magnetic electrostimulation chair bears the advantage of not needing electrodes or the introduction of vaginal or anal probes for treatment. In the paper published by Guilling et al, besides magnetic electrostimulation, the patients from both groups were instructed to do perineal exercises, although with “low load” and, in general, both groups improved in comparison to baseline values. Nevertheless, when the simulated treatment and active treatment groups were compared, there was no statistically significant difference concerning the parameters studied. In relation to one of the values studied (20 minute pad-test), those patients with low muscle strength during initial evaluation had less urinary loss when compared to those with similar strength from the simulated treatment group. If these results are confirmed, the electromagnetic electrostimulation chair can be an alternative to the use of biofeedback to improve results in this subgroup of patients.

Aparecido Donizeti Agostinho