Historical publications

Effectiveness of non-invasive magnetic stimulation of the pelvic floor in the control of urinary incontinence

Objectives: To determine the safety and effectiveness of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence.

You may download the full report in PDF format:
Effectiveness of Non-invasive Magnetic Stimulation of the Pelvic Floor in the Control of Urinary Incontinence (PDF 339 KB)

You may read the Summary below, or the full report online.

1. Executive Summary

This project was a randomised controlled trial of magnetic stimulation of the pelvic area, using a commercially available product. This product consists of a garment that resembles underpants but with magnets incorporated into the design. The small magnets are sewn into the fabric of the garment and the garment is adjusted so that the magnets are placed with reference to anatomical landmarks. Preliminary studies conducted by the manufacturer suggested that this type of system may provide a useful treatment for urinary incontinence.

The objective of the study was to determine the safety and effectiveness of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence.

A double blind randomised controlled trial was undertaken with 122 women, aged 60 years and over, who had had urinary incontinence for at least 6 months. Subjects were randomly assigned to the active SMS group or the placebo group. Each participant in the treatment group wore an undergarment incorporating 15 static magnets of 800 to 1200 Gauss anterior, posterior and inferior to the pelvis for at least 12 hours a day for three months. The placebo group wore the same undergarment with inert metal disks replacing the magnets. Outcome measures included the 24 hour pad test, the Bristol Female Lower Urinary Tract Symptoms – Scored Form (BFLUTS-SF) questionnaire, the Incontinence Severity Index (ISI), a Bothersomeness Visual Analogue Scale and a 24-hour Bladder Diary.

Sixty-two women were randomised to the intervention group and 60 to the control group. Fifty-one participants in the intervention group and 50 participants in the control group provided at least some follow-up data. There were no statistically significant differences in change in objective outcome measures (Pad test, frequency of continent and incontinent episodes, BFLUTS-SF, ISI, Bothersomeness Score) between the two groups by the end of the study. There was initial evidence of subjective improvement in symptoms of urinary incontinence for those wearing the pants when compared to a placebo controlled group. However, once those who could correctly identify their group allocation were removed from the analysis there were no statistically significant differences apparent between the groups. The qualitative data suggested that the garment was uncomfortable and hot to wear.

No significant differences between the magnetic and non-magnetic undergarments on the key outcome measures were found. This could be due to a variety of reasons: no magnetic effect on these outcomes, small sample size, issues related to design and protocol adherence. The qualitative data suggested that there are some design issues with the product especially for use in a sub-tropical climate. This meant that the recruitment to a clinical trial was difficult and adherence to the protocol was even more difficult. For these reasons the lack of effect seen in the intervention group must be treated with caution. It may be that there is an effect if the garment is worn as designed; however, the effectiveness of the garment cannot be confirmed from the results of this study.

Further research needs to be undertaken into the basic physics of the strength and flux of the magnetic field generated by the product. Once this work is completed additional animal and clinical trials may be planned. Future clinical trials would need to include up to 250 women with urinary incontinence in both the intervention and control groups. Innovative recruitment and blinding strategies would have to be used and some design modification may improve adherence in sub-tropical climates.
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2. Description of the report

The final report, in accordance with item D4 in the schedule attached to the “Agreement between the Commonwealth of Australia as represented by the Department of Health and Ageing and Griffith University” will address the following:

• Results of the trial and whether these indicate conclusively or otherwise that magnetic stimulation of the pelvic floor was effective in treating incontinence for each of the participants, including statistics collected in the course of the Project.
• Recommendations on how any outcomes or objectives that were not achieved could be achieved in the future.

3. Description and aims of the project

This project was a randomised controlled trial of magnetic stimulation of the pelvic area, using a commercially available product. This product consists of a garment that resembles underpants but with magnets incorporated into the design. The small magnets are sewn into the fabric of the garment and the garment is adjusted so that the magnets are placed with reference to anatomical landmarks. Preliminary studies suggest that this type of system may provide a useful treatment for urinary incontinence.

These underpants are relatively cheap to purchase and anecdotal reports, from sufferers using them, suggested that women with chronic urinary incontinence may go from having numerous episodes of stress or urge incontinence in a day to being fully continent in four weeks. If these findings can be replicated in a rigorous scientific study this relatively cheap product could be of enormous benefit to older adults who may be at risk of institutionalisation because of worsening urinary incontinence. In this way, the project met one of the main aims of the National Continence Management Strategy.

Thus the specific aims of the project were to:

• test the efficacy of a non-invasive, easy to use, cost-effective method of treatment for urge and mixed urinary incontinence in women aged 60 years and over;
• assess useability and acceptability of the system by older women.

It was expected that this project would result in:

• availability of Australian data based on a rigorous, randomised, double-blinded, placebo-controlled trial;
• recommendations regarding the efficacy of magnetic stimulation of the pelvic area for a specific group;
• recommendations regarding the ongoing use of the specialized undergarment.

4. Project teams

To conduct the study the grant recipients engaged one team to conduct the research and a clinical team to assist with recruitment and to provide expert clinical support. The teams were:

Research Team

Prof Marianne Wallis – Griffith University Research Centre for Clinical Practice Innovation and Gold Coast Health Service District Chief investigator
Prof Elizabeth Davies – University of Queensland, School of Nursing Investigator
A/Professor Lukman Thalib – University of Kuwait, Faculty of Medicine Statistician
Ms Susan Griffiths - Griffith University Research Centre for Clinical Practice Innovation Project Co-ordinator
Ms Karen Sherriff - Gold Coast Health Service District Research Assistant – randomisation
Ms Nerolie Bost - Griffith University Research Centre for Clinical Practice Innovation Research Assistant

Clinical Advisory Team

Ms Shona McKenzie - The Prince Charles Hospital and Royal Brisbane Hospital Continence Nurse Advisor
Ms Kay Josephs - Blue Care Continence Nurse Advisor
Ms Michelle King Gold Coast health service District Continence Nurse Advisor
Ms Leanne Morton Royal Brisbane Hospital Continence Nurse Advisor
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5. Project Progress

Overall the project progressed well. There were no complaints received about the trial from any of the participants either by the investigators or by any of the Human Research Ethics Committees (HRECs) involved. However, the final report is being submitted later than predicted because of unforeseen difficulties with HREC approval and with difficulties in recruiting sufficient participants into the randomised controlled trial.

A. Ethics

Ethical approval was granted by the following HRECs: Griffith University, the University of Queensland, Royal Brisbane and Women’s Hospital Health Service District, The Prince Charles Health Service District, The Gold Coast Health Service District and Blue Care. The time taken to organise approval by all six committees delayed the commencement of the project.

B. Changes to Project Plan

There were no changes to the trial protocol during the project. Participants wore the undergarment for a period of 12 weeks and completed the outcome measures at the stated intervals. Participants were effectively randomised into either the treatment or the placebo group.

There was a change to the original recruitment strategy. Initially women with urinary incontinence were to be recruited to the trial via the continence clinics they attended. These continence services included the Royal Brisbane continence service, the Waterworx Centre, The Prince Charles continence clinic, the Blue Care continence service (Brisbane Central) and Ozcare continence service.

Recruitment via the participating clinics was slower than anticipated. Some pre-existing barriers, unforeseen at the outset, limited the availability of eligible clients and the time needed to introduce clients to the research trial. As some services are funded under the HACC scheme, their clients must meet the criteria prescribed by that funding system. The eligibility criteria, explicit to the design of this trial, were incongruent with the ‘frail aged’ criteria of HACC based services. Women were to be independently living and not limited in their physical functioning, such that taking a moderately-weighted undergarment on and off, would not be difficult. Further, participants were required to independently complete a number of questionnaires associated with the trial. This precluded many clients of the above services as they were experiencing some degree of dementia. Another problem impeding recruitment via the clinical sites was the paperwork required as part of the enrollment process. This was in addition to a significant amount of forms requiring completion when registering a client to a HACC funded service. This particular issue led to a joint agreement between Ozcare and the Chief Investigator that they would not recruit clients to this particular trial.

It was therefore recognised, some months after recruitment had begun, that conforming to this strategy alone would not meet the required sample size. Another strategy was devised to facilitate a faster rate of recruitment and to reach a wider population of women who were more likely to meet the trial eligibility criteria. Initially, flyers were developed to be distributed to GP practices, pharmacies and relevant clinical sites, such as women’s centres. Members of the research team visited sites to inform the staff about the study and the participant profile. Posters were also developed to advertise the trial within a hospital environment. This initial promotion was followed by a more intensive and costly advertising strategy. This involved the design of a newspaper advertisement by the External Relations team at Griffith University. This advertisement was published in the Sun Community paper for the Gold Coast and Tweed region on four consecutive fortnights (13 April to 25 May 2005).

An amendment to the original recruitment strategy was submitted to all participating HRECs and each committee formally approved the amendment.

The Department of Health and Ageing was informed of the changes and delays (as was the IEA) and an extension was given of the project until February 2006.

6. Study results and materials

For study results see report.

For materials associated with the project (data collection instruments and participant instructions) see appendices 1 & 2.

7. Publication Plan

It is planned to submit an article related to the results of the study to a medical journal such as Urology and a separate article related to methodological issues involved in outcomes focused UI research to a journal such as The Journal of Urology. A short publication will also be prepared for the Australian and New Zealand Continence Journal. An article discussing difficulties involved in controlled trials of magnetic products will be submitted to either a nursing or allied health journal.

The results of the study will be presented at the 2006 Australian and New Zealand Continence Conference. Top of page