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

Abstract

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.

Functional variability of sacral roots in bladder control

“…Gilling et al 4 described the use of this technique to stimulate S-3 nerve roots bilaterally via their sacral foramina to reduce idiopathic bladder hyperactivity. However, no study has determined the functional variability of sacral roots.…”

Conservative treatment for female stress urinary incontinence:

“…Several early uncontrolled trials reported efficacy in urinary incontinence treatment, with improvement rates from 35% to 70%, 21,22 whereas in controlled trials the results were conflicting 14,23 and no additional benefit over PFMT was demonstrated. 24,25 The lack of evidence is compounded by differences in stimulation parameters and duration of treatment. Women with SUI who are having difficulties to correctly perform PFMT may benefit from a device which directly stimulates contraction of the pelvic floor.…”

Physiotherapy treatment of urinary stress incontinence in women. Part 2

“…Nie można pominąć treningu skupionego na długiej kontrakcji mięśni (stymulacja włó-kien S). Wykazano, że stymulacja mięśni dna miednicy zwiększa liczbę włókien mięśniowych typu S w okolicy okołocewkowej [29,30]. Nie zaleca się stosowania elektrostymulacji u pacjentów zdolnych do wolicjonalnego skurczu mięśni dna miednicy [6].…”