Use of a vaginal sponge during aerobic exercises in patients with stress urinary incontinence. A new intravaginal device for stress incontinence in women. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Prevention of exercise incontinence with mechanical devices. A randomized controlled trial of the NEAT expandable tip continence device. The urethral plug II: an alternative treatment in women with genuine urinary stress incontinence.
A newly marketed vaginal sponge intended to support the urethra was tested during aerobic exercise in a group of 6 women suffering from stress urinary incontinence. The patients performed half an hour of aerobic exercises on 2 consecutive days, with and without the vaginal sponge. A pad was worn during exercise and weighed before and after. Without the vaginal sponge the patients had a mean loss of 7 g (range 2-18 g) during exercise. With the vaginal sponge in situ there was no leakage. The sponge can be recommended for use during sports in patients with mild to moderate incontinence. 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, Humlebaek, Denmark) for treating stress incontinence in women.
                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.
                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.
                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. To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy.
                This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach.
                At 3 months, scores from 40% of the pessary group and 49% of the behavioral group were "much better" or "very much better" on the Patient Global Impression of Improvement (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups.
                Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998. A prospective, randomized, single-blind study addressed the hypothesis that simple mechanical barriers are helpful in controlling urinary incontinence during exercise. Eighteen incontinent exercisers aged 33-73 participated in three 40-minute standardized aerobics sessions wearing either a Hodge pessary with support, a super tampon or no mechanical device. Urine loss was determined by a change in the weight of the pad worn while exercising. Statistical analysis of the log of urine loss revealed that women lost significantly less urine when exercising with either the pessary or the tampon than when exercising with no device. Thus, both devices studied are useful, nonsurgical alternatives for some women for the treatment of exercise incontinence. Urethral devices are one conservative management option for stress and mixed urinary incontinence, but there is little published data about their use. The aims of this study were to assess the safety and efficacy of a new urethral device (NEAT) and compare it with the Reliance Insert. The ease of use of both devices was then evaluated. Twenty-four women with mixed or stress urinary incontinence, patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria, were enrolled in the study. Study subjects were blinded and randomly assigned to a device group. Device efficacy was assessed by pad weighing at 0 and 4 months. Success was defined as a 50% or greater reduction in urine loss using the formula 100[(pad weight without device -pad weight with device)/pad weight with device]. Safety was evaluated using urinalysis and urine cultures. Ease of use assessment scales were also completed. Eleven patients were randomized to the Reliance Insert and 13 to the NEAT device. There were no significant differences between the two groups in age, height, weight, duration of incontinence, pad weight, leakage score, parity or quality of life score. Based on the pad weight success formula, there was no significant difference in device success between the two groups at 4 months. Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight. Previous treatment, diagnosis and hormone replacement therapy all had no relationship to device success. Leakage score data showed that subjects had a significant decrease in urine leakage when using either device. There was no statistically significant difference in ease of use between the two devices. Adverse symptoms most commonly noted were awareness of the device (62.5%), urgency (29.2%), and urethral discomfort or pain (20.8%). One urinary tract infection (UTI) was observed. The most common finding on urinalysis was trace hematuria (15.8%). Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert. Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence. The risk of UTI is low, but these devices may cause trace hematuria. An improved design of the recently developed urethral plug was evaluated for the treatment of women with genuine urinary stress incontinence. The plug consists of an oval meatal plate, a soft stalk and 1 or 2 spheres along the stalk with fixed distances between the meatal plate and the spheres. Inside the stalk is a removable semi-rigid guide pin to ease insertion. Forty women were randomly allocated to treatment with either the 2-sphere or the 1-sphere plug during period 1 (2 weeks). In period 2 (2 weeks) the patients used the other plug. They then continued with what they judged to be the better plug in period 3 (2 months). Eighteen patients (45%) completed period 3 with the "preference" plug and 17 were subjectively and objectively continent or improved. Fourteen of these women preferred the 2-sphere device. The plugs were equally effective in patients with mild or severe incontinence. To accommodate variations in urethral length and to avoid the loss of plugs, the devices are available in different lengths. Six women developed urinary tract infections and 2 of these had a plug in the bladder. The urethral plug is an effective treatment in a group of women with stress incontinence. Removal by hand is advisable in order to avoid retention of plugs in the bladder.
The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.