Neurourology and Urodynamics

Efficacy of Electromagnetic Therapy for Urinary Incontinence: A Systematic Review Renly Lim,1 Shaun Wen Huey Lee,2* Ping Yee Tan,2 Men Long Liong,3 and Kah Hay Yuen1 1

School of Pharmaceutical Sciences, University of Science Malaysia, USM, Penang, Malaysia 2 School of Pharmacy, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia 3 Department of Urology, Island Hospital, Georgetown, Penang, Malaysia

Aims: To review whether patients with urinary incontinence (UI) treated with magnetic stimulation (MS) have a higher continence rate compared to sham. Methods: Computerized search of electronic databases was performed using the keywords magnetic stimulation therapy and urinary incontinence. Inclusion criteria were randomized, blinded and shamcontrolled. Results: Eight studies involving 494 patients were included (285 patients received active MS and 209 patients received sham MS). Sample size ranged from 20 to 151 participants. Three studies were on stress UI, two studies on urgency UI, two studies on mixed UI and one study on overactive bladder. The primary outcome (cure) was not reported since only one study reported this outcome. Meta-analysis of the secondary outcome (improvement) showed patients who received active treatment were 2.3 times more likely to experience improved continence compared to sham treatment (95% confidence interval: 1.60-3.29; P < 0.001), but was subject to bias due to varying inclusion criteria, poor reporting and variable time points. There were conflicting results in the treatment effect on quality of life (QOL). Twenty out of 494 patients (5%) experienced mild side effects. The longest follow up period was six months. Conclusions: There is no firm evidence to support the benefits of using MS in the management of UI, although short-term outcomes suggests that MS improves UI symptoms in women. The applicability of MS as a treatment option for UI remains uncertain until larger, high-quality trials with longer follow-up periods using comparable and relevant outcomes are conducted. Neurourol. Urodynam. # 2014 Wiley Periodicals, Inc. Key words: device safety; magnetic stimulation; quality of life; urinary incontinence

INTRODUCTION

Urinary incontinence (UI), defined as the complaint of any involuntary loss of urine, is a chronic and debilitating condition which reduces quality of life (QOL), similar to severe chronic diseases such as stroke, arthritis, and chronic kidney disease.1,2 This condition is particularly devastating to patients especially in relation to the physical and emotional aspects.2–4 Prevalence estimates are heterogeneous, ranging from 7% to 53%, with a universal conformity that the prevalence rates increase with age.5–7 Nevertheless, these figures may well be an underestimate, as this condition remains a taboo for many patients due to the associated social stigmatization.3,4 The three most common types of UI affecting patients are: (i) stress urinary incontinence (SUI); (ii) urgency urinary incontinence (UUI); and (iii) mixed urinary incontinence (MUI).8 Other less common categories include nocturnal enuresis, post-micturition dribble, continuous UI, and UI due to idiopathic or neurogenic detrusor overactivity. SUI involves involuntary leakage of urine during physical exertion, such as during coughing, sneezing, and laughing, and is associated with weakness of the pelvic floor muscles.8 UUI meanwhile is defined as the involuntary loss of urine associated with a sudden and compelling desire to pass urine which is difficult to defer, while MUI is a combination of SUI and UUI. The current first line treatment advocated for SUI is pelvic floor muscle training (PFMT)8,9 with PFMT combined with either bladder training or antimuscarinics advocated for UUI. Other adjunct therapies such as electrical stimulation (ES), vaginal cone and urethral insert are reserved as the second-line conservative treatment options for both SUI and UUI. #

2014 Wiley Periodicals, Inc.

Magnetic stimulation (MS) is a novel approach approved as a conservative treatment for UI by the United States Food and Drug Administration since 1998.10 Since then, over 50 clinical studies have been conducted worldwide to evaluate its efficacy in UI.11 Clinicians, healthcare providers and policy makers are overwhelmed by the multitude of information and there is a need to amalgamate these information to allow for evidencebased decision making. To date, no systematic review has been performed to specifically assess the efficacy of MS for UI. Hence, the magnitude of its benefits and harms are not completely established. Our present review synthesizes existing evidence to establish whether patients with UI treated with MS, compared to sham, have a higher continence rate. MATERIALS AND METHODS Evidence Acquisition and Search Strategy

Trials were identified from January 1998 until March 2014 using the electronic databases; Medline, EMBASE, CINAHL, and

Robert Pickard led the peer-review process as the Associate Editor responsible for the paper. Potential conflicts of interest: Nothing to disclose.  Corresponding author: Shaun Lee Wen Huey, School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway, Selangor, Malaysia, 46150. E-mail: [email protected] Received 23 May 2014; Accepted 12 August 2014 Published online in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22672

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Renly et al.

the Cochrane Collaboration’s Database of Systematic Reviews. The medical subject heading was searched by combining the following search terms: magnetic stimulation therapy and urinary incontinence. Additionally, multiple free text searches were executed, for the following search terms individually: magnetic stimulation, magnetic innervation, functional extracorporeal magnetic stimulation, functional magnetic stimulation, extracorporeal magnetic innervation, electromagnetic pelvic floor stimulation, extracorporeal magnetic stimulation, and neuromodulation (Supplement 1). This was supplemented by a manual search of congress abstracts presented at the International Continence Society, American Urological Association Annual Meeting and European Association of Urology from 2000 to 2014. These cut off dates were chosen because MS for UI was approved in 1998, while any abstracts earlier than 2000 would most likely have been published. Study authors were contacted for clarification where necessary. No restrictions on language or type of publication were applied. Selection of Studies

Studies were eligible if they were randomized, blinded and sham-controlled, using MS for UI. Where there were duplicates in congress abstracts and published journals, the data was crosschecked to verify equivalence, and the most up-to-date or complete publications were chosen.

EVIDENCE SYNTHESIS

The bibliographic records obtained via the database search were imported into Endnote X6 (Thomson Reuters, New York, NY). Records from different databases were merged, and duplicates were removed. Two independent review authors (LR & SL) screened titles/abstracts identified from the electronic database search. Full-text articles of potentially relevant studies were retrieved and independently assessed to confirm eligibility. Both authors extracted the data using a standard extraction template. The selected publications were evaluated independently for their methodological quality using the Jadad score 12 and Cochrane risk of bias assessment tool.13 Any discrepancies were documented and resolved through discussion. Both objective and subjective outcomes were considered. The primary outcomes of interest were the proportion of patients who were continent at the end of study and treatment effect on QOL. The definitions of cure and improvement were according to those provided in the primary studies. Secondary outcomes included incontinence episode frequency, daytime frequency, nocturia, micturition frequency per 24 hr, volume of urine voided per 24 hr, maximum voided volume, pad test, pelvic floor muscle contraction, and number of pads per day. Meta-analysis was performed using Review Manager software v.5.2 (Cochrane Collaboration, Oxford, UK). Random effects models were used to produce an across study risk ratio with a 95% confidence interval (CI). Statistical heterogeneity between studies was assessed using x2 test and I2 statistic and the source of heterogeneity explored if present. The study was performed in accordance with the PRISMA (Preferred Reporting Items for Systematic Review and MetaAnalyses) statement.14

RESULTS Study Characteristics

The literature search of the electronic database identified 990 studies, of which 101 full-text articles were assessed for eligibility (Fig. 1). Eight studies met the inclusion criteria.15–22 Two sham-controlled RCTs were excluded from our analysis due to their cross-over study design.23,24 Ninety one other studies were excluded, for the reasons specified in Figure 1. Overall, 494 patients were enrolled, wherein 285 patients received active MS and 209 patients received sham MS. Only three trials reported an a priori power calculation.19,21,22 Sample size ranged from 20 to 151 participants. Three studies focused on SUI only, two studies included UUI only, two studies on MUI, and one study on overactive bladder (OAB). Three studies were conducted in Japan, two in Slovenia and one each in Italy, New Zealand and Australia, and all studies included women only. The descriptive characteristics of studies are summarized in Table I. A detailed method of randomization and allocation concealment was described in two studies. Blinding was achieved in four studies, in the remainder they were absent or unclear. Only one study provided a detailed description of participants who withdrew or were lost to follow-up. Study quality was diverse, ranging from low to high (0–4) on a Jadad scale (Table I). Using the Cochrane risk of bias assessment tool, most studies had either low or unclear risks of bias in most criteria. The risk of bias graph and summary are illustrated in Figures 2 and 3 respectively. There was substantial divergence in relation to the frequencies and durations of stimulation, ranging from 5 Hz to 50 Hz, and 20 min to daily usage. Likewise, treatment periods were inconsistent, from as short as a single session to three months, with a wide variability in designs. Although all studies

Role and Source of Funding

No funding was sought for this study. This study is registered with PROSPERO under the registration no CRD42014008836. Neurourology and Urodynamics DOI 10.1002/nau

Fig. 1. PRISMA study flow diagram.

Neurourology and Urodynamics DOI 10.1002/nau

Slovenia17

But, 2003,

2014, Japan22

Yamanashi,

Fujishiro, 2002, Japan16

Zealand

52

151

37

70

55.8

65.2

62

54.4

21

Gilling, 2009, New

50.1

(2.86)

20

58

Italy20

Manganotti, 2007,

Japan15

62

location

Fujishiro, 2000,

enrolled (years, SD)

Study, year,

Mean age

No. of patients

inactive device

Sham: Stimulation with

week for 2 weeks

Active: 15 min, 3 days a

Sham: Stimulation with inactive device

30 min

Active: 5 sec/min for

Treatment protocol

lower limb metallic prosthesis

>200 ml, PFR >10 ml/sec, PVR 18 years,

electrical stimulation 12 weeks; intolerance to drugs,

Stress dominant UI; IC;

frequency or UI

uterine myoma, treated for

bladder, SUI, UTI, IC or large

and safety of MS for the treatment of UI

To evaluate the efficacy Incontinence during drug

frequency and UUI.

roots for urinary

Neurological disorder suggesting neurogenic

components, pelvic or

cystometric capacity of

sham ES.

8 voids daily and/or 1 episode of UI, 6

months; failed pharmacotherapy or

anticholinergic

women.

63 O’Reilly, 2008, Australia19

coil

IC, interstitial cystitis; LUTS, lower urinary tract symptom; MS, magnetic stimulation; MUI, mixed urinary incontinence; OAB, overactive bladder; PFR, peak flow rate; POP, pelvic organ prolapse; PVR, post void residual; SUI,

Not stated 12 hr, nocturia, SUI; bladder 84 days, attend follow up OAB symptoms in

Sham: Sham stimulating

Active: 20 min/day for 12 weeks

Efficacy of electromagnetic therapy for urinary incontinence: A systematic review.

To review whether patients with urinary incontinence (UI) treated with magnetic stimulation (MS) have a higher continence rate compared to sham...
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