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Female devices: are your patients missing out?

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VOL: 97, ISSUE: 06, PAGE NO: 3

Ray Addison, RN, FETC, Cert.H.Ed, BSc, is nurse consultant in bladder and bowel dysfunction, Mayday Healthcare NHS Trust, Croydon, Surrey

Jenni Roberts, RN, DN.Cert, is nurse specialist, bladder and bowel dysfunction, Mayday Healthcare NHS Trust, Croydon, Surrey

Female urinary stress incontinence is caused either by intrinsic sphincter weakness and/or hypermobility of the bladder neck. Either or both these result in stress incontinence. Female devices are either placed in the vagina to increase sphincter pressure and/or reduce sphincter mobility, or are used within the urethra to obstruct flow and leakage.

Female urinary stress incontinence is caused either by intrinsic sphincter weakness and/or hypermobility of the bladder neck. Either or both these result in stress incontinence. Female devices are either placed in the vagina to increase sphincter pressure and/or reduce sphincter mobility, or are used within the urethra to obstruct flow and leakage.

Female devices therefore aim to prevent urinary leakage rather than contain it with pads. Yet, although these devices are very effective, the number of women using them is comparatively small.

Female devices
Several female devices have been developed and positively evaluated. The Reliance urinary control insert was a sterile, single-use, pliable plastic device, which was inserted into the urethra by means of an applicator and held in place by an inflatable balloon, thus occluding the bladder neck and preventing leakage of urine. Despite positive evaluation the product is no longer manufactured.

Femassist was a device made of medical-grade silicone which was placed over the female urethral meatus where, with the aid of a sealing ointment, it attached like a suction cup. Users reported objective improvements in incontinence. However, the product is no longer available in the UK.

There are two female devices widely available in the UK at present. Contiform is a device described as soft, flexible and unlikely to cause allergy. It is intended to support the urethra and bladder neck and may be worn all day or when needed (including during menstruation). After being moistened with water, it is inserted digitally into the vagina by the user - a procedure simular to inserting a tampon. The device is removed by inserting a finger into the vagina to engage with the device, which is then withdrawn.

Contiform comes in three sizes, is reusable for up to 30 days and is available from pharmacies and health care professionals with supporting literature and a video. Biswas (1999), who invented Contiform, undertook a prospective Australian-based study of 29 women using it. Six dropped out of the study, 19 were totally dry at one and nine months. Frequency and volume of leakage was reduced in the others and Contiform was found to be cost-effective.

Conveen Continence Guard is a single-use wing-shaped device, made of soft polyurethane rubber, in three sizes, which is inserted into the vagina using an applicator. It is only available by mail order. To prevent absorption of vaginal moisture, the device is saturated in water, then squeezed to remove any excess before use. Lubrication, plus hormonal cream for menopausal women, is recommended to ease insertion. The device is put on to an applicator, with the wings pointing to the urethra and anus. Following insertion the applicator is withdrawn, leaving the thread accessible for withdrawal. The product can be left in the vagina for up to 16 hours but during menstruation should be changed every four to six hours. Thyssen and Lose (1996) undertook a prospective study of 26 women without major genital prolapse. Four patients dropped out of their study, four lost the device on straining while passing a stool and three obtained no benefit from it. Others reported a significant reduction in pad usage and leakage, with no complications or infections caused by the device.

Patient assessment
Assessment of a patient wishing to use a female device should consider the following:

- The cause of the patient's incontinence. Female devices are used to manage stress urinary incontinence, although they can be used with mixed incontinence;

- The patient's cognitive ability;

- The patient's ability to handle, insert and remove the device;

- The patient's financial circumstances. No devices are currently available on prescription and the cost varies between devices.

Contraindications include significant genital prolapse, urinary and vaginal infection, soreness and erosion.

Female devices may be useful for patients with stress incontinence who do not want to have corrective surgery or when surgery has been unsuccessful.

Issues concerning female devices
Although research related to individual devices is limited, there is no doubt about the efficacy of female devices in general in the management of stress urinary incontinence. The evidence shows minimal complications of a non-serious nature, particularly with vaginal devices such as Conveen Continence Guard and Contiform (Thyssen and Lose, 1996; Biswas, 1999).

In the light of positive research and commercial investment, why are they not more commonly used? It may be that the main interventions offer to patients continues to be dominated by pads, exercises, surgery and medication. A change in continence care philosophy is needed to ensure that patients are offered an informed choice of products and interventions. Pelvic muscle education leaflets must mention devices and invite consultation, which may then lead to discussion of female devices suitable for treatment.

Reflecting on practice
If you are involved in the assessment of women with continence problems, ask yourself the following questions:

- How many female patients have you seen in the past four weeks with urinary incontinence?

- How many of these were given information about female devices?

- How successful have they been in those who chose to try them?

- What were the reasons your patients gave for not using a female device?

- If you did not inform your patients of female devices, what was your rationale?

- What do you assess for when checking suitability for a female device?

- How competent do you feel in the use of female devices?

- How many patients who you feel may be suitable for a female device have you referred to your continence adviser in the past four weeks? Did you refer because you do not feel competent to advise, fit and follow up?

- Does your continence service have samples and leaflets on female devices?

- Does your continence adviser provide professional training in the use of female devices?

- Have you ever contacted a company helpline about female devices or asked for literature, research and samples?

- Would you be negligent if you did not inform suitable female patients you see with stress urinary incontinence about female devices from now on?

Conclusion
Female devices are a logical way to treat stress incontinence. There is a collective body of evidence to support their use but this is not reflected in clinical practice. Female devices raise the issue of professional competency and knowledge, patient acceptability ad compliance set against accessibility and cost. Do consider a female device next time you assess a woman with stress urinary incontinence.

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