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Conservative treatment of female urinary incontinence with functional magnetic stimulation.
Department of Gynecology, Maribor Teaching Hospital, Maribor, Slovenia.
OBJECTIVES: To determine the efficacy and safety of functional
magnetic stimulation (FMS) produced by the Pulsegen device compared with
placebo in the treatment of women with urinary incontinence.
METHODS: Fifty-five women with urinary incontinence were randomly
assigned to the active FMS group (30 patients) or the placebo group (22
patients). Each patient in the active group received a Pulsegen device,
which produced a pulsating magnetic field of B = 10 microT intensity and
a frequency of 10 Hz. Patients were asked to wear the Pulsegen device
day and night for 2 months. Clinical and urodynamic data were collected
before and after FMS and analyzed using nonparametric statistics.
RESULTS: Compared with the placebo, the number of pads used was
significantly lower (P = 0.0031) after FMS, as was the pad weight (P =
0.014). In patients from the active group, a significant improvement in
the power of the pelvic floor muscle contractions (P = 0.0071), as well
as in the duration of the pelvic floor muscle contractions (P = 0.038),
was observed. After FMS, a 56.3% improvement in urinary incontinence
symptoms was reported by patients in the active group, a significantly
greater difference (P = 0.00012) compared with the reported 26.3%
improvement in symptoms in the placebo group.
CONCLUSIONS: We believe that FMS represents a new method in the
conservative treatment of urinary incontinence. Magnetic stimulation
with the Pulsegen device is efficient and safe. It can be used at home
and, because of its small size, wearing the device is not annoying for
patients.
Urology. 2003 Mar;61(3):558-61.
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Extracorporeal magnetic stimulation for the treatment of stress and urge incontinence in women--results of 1-year follow-up.
Unsal A, Saglam R, Cimentepe E.
Department of Urology, School of Medicine, Fatih University, Ciftlik
Cd. No: 57, TR-06510 Emek, Ankara, Turkey. unsalali@hotmail.com
OBJECTIVE: To evaluate the clinical efficacy of extracorporeal
magnetic stimulation for the treatment of stress and urge urinary
incontinence in women.
MATERIAL AND METHODS: A total of 35 patients with stress incontinence
and 17 with urge incontinence were enrolled in this study. All patients
were evaluated by means of a detailed history of incontinence, a
gynecologic examination, urine culture, urinary system ultrasound and a
urodynamic study. All patients were asked to keep a 3-day voiding diary.
A pad-weighing test was done for each patient at their first visit. For
treatment, the patients were seated on a special chair containing a
magnetic field generator. Pelvic floor muscle stimulation was performed
for 20 min (10 min at 5 Hz and 10 min at 50 Hz) twice a week for a total
of 8 weeks. The mean follow-up period was 16.8 months (range 12-32
months). A total of 44 patients completed 1 year of follow-up and were
re-evaluated by means of voiding diary, pad-weighing test and
cystometric study.
RESULTS: Of the 44 patients, 11 (38%) with stress incontinence and 6
(40%) with urge incontinence were cured 1 year after the treatment. In
addition, there was an improvement in symptoms in 12 patients (41%) in
the stress group and 7 (47%) in the urge group. Pad weight was reduced
from 15.4 to 5.8 g in the stress group and from 12.4 to 4.7 g in the
urge group (p = 0.000 and 0.001, respectively). Mean Valsalva leak point
pressure was increased from 87.3 +/- 15.9 to 118.0 +/- 11.0 cmH (2) O
in the stress group (p = 0.000).
CONCLUSIONS: Extracorporeal magnetic stimulation therapy offers a
non-invasive, effective and painless treatment for stress and urge
incontinence in women.
Scand J Urol Nephrol. 2003;37(5):424-8.
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Overactive bladder: magnetic versus electrical stimulation.
Takahashi S, Kitamura T.
PURPOSE OF REVIEW: To review recent literature on the electrical and
magnetic stimulation of the sacral nerve roots and pelvic floor for the
treatment of overactive bladder.
RECENT FINDINGS: Overactive bladder is a common condition affecting
millions of women worldwide, with a significant effect on quality of
life. Electrical stimulation and neuromodulation of the sacral nerve
roots have provided a useful alternative for these patients with
satisfactory outcomes. The use of the procedures has been limited,
however, mainly due to local discomfort/pain or invasiveness of the
surgical procedure. Magnetic stimulation can activate deep neural
structures by induced electric currents noninvasively. Recent
investigations demonstrated that magnetic stimulation of the sacral
roots suppressed detrusor overactivity more effectively compared with
electrical stimulation. Clinical trials including randomized
placebo-controlled studies demonstrated the excellent short-term effect
of magnetic stimulation in the treatment of overactive bladder.
SUMMARY: Magnetic stimulation appears to induce inhibitory effects on
detrusor overactivity in a similar manner to electrical stimulation,
with significant clinical advantages. Although further studies are
needed to establish long-term efficacy, magnetic stimulation of the
sacral nerve roots may be a promising alternative treatment for
overactive bladder.
Curr Opin Obstet Gynecol. 2003 Oct;15(5):429-33.
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Comparative study of effects of extracorporeal magnetic innervation
versus electrical stimulation for urinary incontinence after radical
prostatectomy.
Yokoyama T, Nishiguchi J, Watanabe T, Nose H, Nozaki K, Fujita O, Inoue M, Kumon H.
Department of Urology, Okayama University Graduate School of Medicine and Dentistry, Okayama, Japan.
OBJECTIVES: To perform a randomized comparative study to investigate
the clinical effects of extracorporeal magnetic innervation (ExMI) and
functional electrical stimulation (FES) on urinary incontinence after
retropubic radical prostatectomy.
METHODS: Thirty-six patients with urinary incontinence after radical
prostatectomy were randomly assigned to three groups (12 patients each
in the FES, ExMI, and control groups). For FES, an anal electrode was
used. Pulses of 20-Hz square waves at a 300-micros pulse duration were
used for 15 minutes twice daily for 1 month. For ExMI, the Neocontrol
system was used. The treatment sessions were for 20 minutes, twice a
week for 2 months. The frequency of the pulse field was 10 Hz for 10
minutes, followed by a second treatment at 50 Hz for 10 minutes. For the
control group, only pelvic floor muscle exercises were performed.
Objective measures included bladder diaries, 24-hour pad weight testing,
and a quality-of-life survey, at 1, 2, and 4 weeks and 2, 3, 4, 5, and 6
months after removing the catheter.
RESULTS: The leakage weight during the 24 hours after removing the
catheter was 684, 698, and 664 g for the FES, ExMI, and control groups,
respectively. At 1 month, it was 72, 83, and 175 g (FES versus control, P
<0.05) and at 2 months was 54, 18, and 92 g (ExMI versus control, P
<0.05) in the FES, ExMI, and control groups, respectively. Finally, 6
months later, the average 24-hour leakage weight was less than 10 g in
all groups. Quality-of-life measures decreased after surgery, but
gradually improved over time in all groups. No complications were noted
in any of the groups.
CONCLUSIONS: ExMI and FES therapies offered earlier continence
compared with the control group after radical prostatectomy. We consider
ExMI and FES to be recommendable options for patients who want quick
improvement of postoperative urinary incontinence.
Urology. 2004 Feb;63(2):264-7.
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Magnetic stimulation of the sacral roots for the treatment of
urinary frequency and urge incontinence: an investigational study and
placebo controlled trial.
Fujishiro T, Takahashi S, Enomoto H, Ugawa Y, Ueno S, Kitamura T, Shafik A
Department of Urology, Institute of Medical Electronics, Faculty of Medicine, University of Tokyo, Tokyo, Japan.
PURPOSE: We designed an investigational study and placebo controlled
trial to evaluate the efficacy of magnetic stimulation of the sacral
roots for treating urinary frequency and urge incontinence.
MATERIALS AND METHODS: A total of 48 women 43 to 75 years old (mean
age 61) with the complaint of urinary frequency and/or urge incontinence
were studied. We applied 15 Hz. repetitive magnetic stimulation of the
sacral roots with 50% intensity output for 5 seconds per minute for 30
minutes. Urodynamic investigations during magnetic stimulation were
performed in 11 cases to evaluate acute effects for lowering urinary
tract function. Another 37 women were enrolled in a placebo controlled
study to investigate short-term effects. The mean number of voids daily,
mean urine volume per void, number of leaks for 3 days and quality of
life score were evaluated before and 1 week after stimulation.
RESULTS: Urodynamic investigations revealed apparent elevation in
mean maximum urethral closure pressure plus or minus standard deviation
during stimulation in all 11 cases (8.4 +/- 3.6 cm. water, p = 0.00001)
and a significant increase in mean bladder capacity after stimulation
(58.2 +/- 50.2 ml., p = 0.003). In the placebo controlled study all
parameters significantly improved in the active stimulation group.
Intergroup comparison showed that mean urine volume per void, mean
number of leaks and mean quality of life score improved more
significantly in the active than in the sham stimulation group (23.5 +/-
25.6 ml. versus 6.2 +/- 22.5, p = 0.04, 3.6 +/- 4.1 versus 0.4 +/- 1.4,
p = 0.04 and 1.4 +/- 1.3 versus 0.4 +/- 0.8, p = 0.01, respectively).
No adverse effects were noted in any patients.
CONCLUSIONS: These results suggest that magnetic stimulation of the
sacral roots may be useful for treating urinary frequency and urge
incontinence.
J Urol. 2002 Sep;168(3):1036-9.
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Magnetic stimulation of the sacral roots for the treatment of stress
incontinence: an investigational study and placebo controlled trial.
Fujishiro T, Enomoto H, Ugawa Y, Takahashi S, Ueno S, Kitamura T.
Department of Urology, Sanraku Hospital, and Department of Neurology
and Urology, Institute of Medical Electronics, Faculty of Medicine,
University of Tokyo, Tokyo, Japan.
PURPOSE: We designed an investigational study and placebo controlled
trial to evaluate the potential efficacy of magnetic stimulation of the
sacral roots for the treatment of stress incontinence.
MATERIALS AND METHODS: A total of 75 patients with stress
incontinence were studied. A 15 Hz. repetitive magnetic stimulation of
the sacral roots with 50% intensity output and duration of 5 seconds per
minute was applied for 30 minutes. Urodynamic investigations under
magnetic stimulation were performed in 13 patients to evaluate acute
effects to lower urinary tract function. There were 62 women (mean age
58 years) enrolled in a placebo controlled study to investigate the
short-term efficacy of magnetic stimulation. The number of leaks for 3
days, amount of urine loss on a pad test and quality of life score were
evaluated before and 1 week after stimulation.
RESULTS: The urodynamic investigations revealed an apparent elevation
of urethral closure pressure induced by stimulation (mean 8.2 +/- 3.0
cm H2O, p = 0.0000004) and a significant increase in bladder capacity
after stimulation (mean 40.0 +/- 51.0 ml., p = 0.0152). In the placebo
controlled study the number of leaks and amount of urine loss on a pad
test significantly decreased more in the active than in the sham
stimulation group (p = 0.0023 and 0.0377, respectively). The quality of
life score significantly improved in the active stimulation group (p =
0.0006) in contrast to no significant improvement in the sham
stimulation group. The improvement rate in the active stimulation group
was 74%, which was significantly higher than the 32% in the sham
stimulation group (p = 0.0009). No adverse effects were noted in any
patients.
CONCLUSIONS: These results suggest that magnetic stimulation of the
sacral roots may be useful for the treatment of stress incontinence.
Further studies are needed to evaluate the long-term efficacy of this
potential treatment.
J Urol. 2000 Oct;164(4):1277-9.
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