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


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.
Gilling
Peter J
PJ
Departments of Urology and Physiotherapy, Tauranga Hospital, Tauranga, New Zealand.
Wilson
Liam C
LC
Westenberg
Andre M
AM
McAllister
William J
WJ
Kennett
Katie M
KM
Frampton
Christopher M
CM
Bell
Deborah F
DF
Wrigley
Patricia M
PM
Fraundorfer
Mark R
MR
D000704:Analysis of Variance; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D016496:Incontinence Pads; D055909:Magnetic Field Therapy / Q000379:methods*; D008875:Middle Aged; D009119:Muscle Contraction / Q000502:physiology*; D017773:Pelvic Floor / Q000502:physiology*; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000628:therapy*