A new intravaginal device for stress incontinence in women

Authors


H. Thyssen, Gynaecological Obstetric Department, Glostrup Hospital, 2600 Glostrup, Denmark.
e-mail: lbon@glostruphosp.kbhamt.dk

Abstract

Objective To compare two versions of the same type of disposable intravaginal device (the Conveen Continence Guard, CCG, and the Contrelle Continence Tampon, CCT, Coloplast a/s, Humlebæk, Denmark) for treating stress incontinence in women.

Patients and methods Women with the predominant symptom of stress incontinence were recruited from four centres in Denmark, Australia and the UK. The women were assessed using a 24-h pad-test, uroflowmetry, postvoid residual urine volume and a voiding diary before treatment, and after 5 weeks using each of the two devices. Vaginal swabs and specimens of urine were sent for culture, and a questionnaire about the subjective effect and adverse events completed at each visit. In all, 94 women were recruited, of whom 62 (66%) completed the study.

Results Both devices reduced the amount of leakage significantly, but the CCT reduced urine loss significantly more than the CCG. Uroflowmetry values and residual urine volume were unchanged when using the two devices. Vaginal culture showed no abnormality during the study period, and only one woman was treated for a urinary tract infection. Side-effects were few and not serious. The women found both devices easy to prepare, insert and use; two-thirds preferred the CCT to the CCG.

Conclusion The new intravaginal device (CCT) is more effective for treating stress incontinence than the currently available version (CCG), and patient acceptability of the new device seems to be superior.

Introduction

A disposable intravaginal device, the Conveen Continence Guard (CCG, Coloplast a/s, Humlebæk, Denmark) has been shown to be effective and safe in managing stress incontinence in women [1–3]. However, the current version of the device requires preparation before use; it must be pre-soaked and fitted onto an applicator, and must be inserted into the vagina and orientated, all of which requires initial practise and manual dexterity. The new version, the Contrelle Continence Tampon (CCT, Coloplast) was designed to solve these problems; it requires no preparation and is supplied ready for insertion within an applicator similar in design to those used for sanitary tampons. As the new device is cylindrical it does not require correct orientation, and manual handling is minimized. The aim of the present study was to compare the efficacy, acceptability and ease of use of the CCT and CCG.

Patients and methods

A randomized, prospective, multicentre crossover study was carried out in centres in Denmark, Australia and the UK. Ninety-four women with the predominant symptom of stress incontinence and no major uterovaginal prolapse were recruited (mean age 50.4 years, range 28–79); 39 were recruited in Denmark, 28 in England and 27 in Australia; 43 were pre- and 51 post-menopausal, 39 received oestrogen replacement treatment, 33 orally and six topically. Forty-eight had previously completed a pelvic floor training programme, nine had undergone incontinence surgery and 29 a hysterectomy.

The CCG is made of hydrophilic polyurethane and requires soaking in water before being placed on a handle-like applicator for insertion (Fig. 1a). The CCT is made of hydrophobic polyurethane and supplied ready-assembled within an applicator, allowing insertion directly into the vagina with no manual contact (Fig. 1b). Both devices are produced in three sizes; women are given a trial pack with all three sizes to allow them to find which size is most suitable. They can be worn from morning to night for a maximum of 16 h. Each device is for single use only and should be disposed of after use.

Figure 1.

a, The old vaginal device (CCG) and its applicator, and b, the new vaginal device (CCT) and its applicator.

The occurrence of toxic-shock syndrome is a concern with any intravaginal device; both devices were evaluated microbiologically during development by the Statens Seruminstitut in Denmark. When Staphylococcus aureus were added to the CCG they were able to grow and produce toxin [1], although microbiological tests during clinical trials showed no significant growth of S. aureus in vivo. The growth of S. aureus was also assessed on the CCT; the device supported no growth and indeed inhibited bacterial growth. The conclusion was that the risk of toxic shock syndrome associated with the CCT was very low, and much lower than with conventional sanitary tampons.

Before treatment with the devices the following baseline investigations were carried out: a complete history, pelvic examination, uroflowmetry, an estimate of postvoid residual urine volume, two consecutive 24-h pad tests [4], completion of a 2-day voiding diary, urine culture and a vaginal swab.

Block randomization was used to allocate the women to use one of the two devices first. Women assessed which size of the device suited them best and were then instructed to insert the devices daily for 5 weeks. Thereafter, the baseline investigations were repeated, this time with the device in place. The number of pads used was registered and a questionnaire about the subjective effect and adverse events when using the device completed. The patients then crossed into the other arm of the study and repeated the process with the other device.

The methods, definitions and units conform to standards recommended by the ICS, except where specifically noted [5]. The study was approved by all four local scientific ethical committees, and informed consent was obtained from all women. Standard statistical methods were used as appropriate to assess the results.

Results

Sixty-two women (66%) completed the study (mean age 51.1 years, range 30–75); 47 (76%) reported leakage daily, 13 (21%) several times a week and two (3%) infrequently. Thirty-two (34%) withdrew from the trial, nine because of discomfort, one because of expulsion of the device and 22 did not attend for follow-up or did not wish to continue the treatment (mean age 49 years, range 30–79).

Of the 62 women who completed the study, 22 (36%) were subjectively continent when using the CCG device, 25 (40%) reported an improvement and 15 (24%) had no change. When using the CCT, 30 (48%) of women were subjectively continent, 22 (36%) were improved and 10 (16%) unchanged. The mean (95% CI) 24-h pad test results at baseline and with the CCG and CCT in place were 43.1 (11.0), 20.2 (12.8) and 10.8 (5.4) g, respectively. Both devices reduced the amount of urinary leakage significantly (P < 0.001) but the CCT reduced the urine loss significantly more than the CCG (P = 0.029). Both devices also reduced the number of pads used significantly, from a mean of 2.7 with no device to 1.4 with the CCG and 1.2 with the CCT. With the CCG in place 14% of the women reported slight voiding difficulties, whereas with the CCT, 23% did so.

The devices act by elevating the bladder neck and there were concerns that use of the devices might lead to an increased incidence of UTI. However, the frequency of micturition, flow rates and urinary residual volumes were not significantly changed when using either of the two devices (Table 1).

Table 1.  The peak flow rate, voided volume, corrected peak flow and postvoid residual urine volume without a device (−), and with the CCG or CCT in place
Median (range)No deviceCCGCCT
  1. Corrected peak flow; peak flow rate/√voided volume.

Peak flow, mL/s 25.9 (7–69) 25.8 (5–60) 24.3 (3–61)
Voided volume, mL251 (10–646)216 (17–600)215 (16–580)
Corrected peak flow, mL/s 1.8 (0.6–3.9) 1.9 (0.6–6.1) 2.1 (0.6–5.5)
Residual urine, mL 18.3 (0–140) 17.1 (0–129) 13.2 (0–97)

Urine culture showed significant bacteriuria in only three women during the study; two had no symptoms and no antibiotic treatment was given. The third woman had an uncomplicated UTI at the baseline visit, which was treated before starting the study. Twenty-one women reported vaginal irritation when using the CCG, but in 12 the irritation was only temporary. Sixteen had irritation from the CCT and in seven this was only temporary.

Vaginal cultures showed no abnormality at each visit; S. aureus was detected in two women but in one only at one visit and in the other at two visits. They had no vaginal symptoms or signs of vaginitis and both continued the treatment with the device, uneventfully.

The women found both devices easy to prepare, and reported that it was easy to handle the applicator and to insert and remove the devices (Table 2). There was no significant difference in the degree of discomfort experienced by women using either device. With the CCG in place 72% felt no bother at all, vs 87% when using the CCT. Five women experienced expulsion of the CCG while straining to defecate, vs six with the CCT. Both devices were used for a median of 12 h per day.

Table 2.  The subjective judgement of the CCG and CCT from the 62 women who completed the study
TaskDeviceEasy, %Difficult, %
PreparationCCG9010
CCT91 8
InsertCCG7525
CCT8416
ApplicatorCCG8317
CCT8020
RemoveCCG91 9
CCT95 5

At the end of the study 63% preferred the CCT and 26% the CCG, with 5% finding the devices equally good and 5% not wishing to use either. Of the 62 women who completed the study, 32 continued the treatment in a 1-year study.

Discussion

Several devices designed to restore continence in women with stress incontinence have been developed recently. Intraurethral devices act by blocking the urethra and are very effective, but they can be difficult to insert, and can cause problems with urethral irritation and UTI. They also need to be removed and discarded to allow voiding, making them too expensive for everyday use. Intravaginal devices such as the present models are a more familiar concept to women, being similar to sanitary tampons. They are easier to use and can be worn for longer without being removed to allow voiding. This makes them more practical for everyday use and reduces the cost.

The present study shows that both the CCG and CCT significantly reduced the amount of urinary leakage in women with stress incontinence. However, the CCT reduced the leakage significantly more than the CCG. Both devices led to a reduction in pad usage. Furthermore, the women found the CCT easier to handle, and caused only few and insignificant side-effects. Two-thirds of the women preferred the CCT to the CCG.

The new design solved the problems encountered with the CCG; the CCT is supplied ready for insertion in an applicator, thereby reducing the amount of preparation, manual contact and manual dexterity required for its use. The CCT can be placed directly into the vagina with no pre-soaking, and the cylindrical shape makes it easy to insert and orientate correctly within the vagina.

The devices are designed to support the bladder neck; in women with stress incontinence, Mouritsen [6] found (using ultrasonography) that bladder neck hypermobility decreased significantly with the CCT in place. In the present study the measurements of peak flow rate and residual urine showed no sign of obstruction of the urethra, which also indicates that the devices act by supporting the bladder neck and not by obstructing the urethra.

There were two cases of vaginal colonization by S. aureus; both women continued to use the devices with no problems. In a long-term study with the CCG [2], two cases of vaginal colonization with S. aureus were also recorded, and both women continued to use the device; new cultures 3 and 12 months later showed a normal vaginal flora. Infections with S. aureus are to be expected, as it is part of the natural vaginal flora [7]. To date, no cases of toxic shock syndrome have been reported after using the CCG.

The use of prosthetic devices can be valuable in the conservative management of women who do not wish, or are unfit for, surgical intervention, or whilst awaiting surgery. They also offer a useful option for women who have not yet completed a family, and in those undertaking pelvic floor physiotherapy. Such devices may allow women to return to a normal level of activity or sport without resorting to surgery.

The new design of disposable intravaginal device is more effective in treating stress incontinence than the CCG, offering increased ease of use and patient acceptability. It may not suit all women, but nevertheless is a valuable addition to the range of therapeutic options available to women with stress incontinence.

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