Effects of Macroplastique Implantation System for stress urinary incontinence and urethral hypermobility in women.

A study was carried out to evaluate efficacy of Macroplastique(R) (MPQ) Implantation System (MIS) in women with urodynamic stress urinary incontinence (SUI) and urethral hypermobility after an unsuccessful conservative treatment. This is a prospective randomized controlled trial in women without previous incontinence surgery. Twenty-four women received MPQ. Twenty-one controls underwent a pelvic floor muscle exercises home program. Follow-up was at 3 months and the MPQ group also at 12 months. At 3 months, pad usage decreased significantly more in the MPQ group than in the control group (p = 0.015). According to physician and patient self-assessment, respectively, 71% and 63% women in the MPQ group were considered cured or markedly improved. This was significantly higher compared to controls. There was a significant higher increase of Incontinence Quality-of-Life questionnaire score in the MPQ group compared to controls (p = 0.017). Improvements in MPQ group at 3 months are sustained to 12 months. Adverse events were mild and transient. MIS is an acceptable option for women with SUI and urethral hypermobility.

Systematic review: efficacy of silicone microimplants (Macroplastique) therapy for stress urinary incontinence in adult women.

OBJECTIVE: To assess the efficacy of silicone microimplants (Macroplastique; polydimethylsiloxane) therapy for stress urinary incontinence in adult women, using a systematic review of identified studies. MATERIALS AND METHODS: A computer-aided and manual search for published studies investigating silicone microimplants therapy for stress urinary incontinence in adult women. The methodological quality of the included studies was assessed using criteria based on generally accepted principles of interventional research. RESULTS: Only two RCTs, only published as an abstract, were found. Eleven pre-experimental or observational studies were identified. Overall, the methodological quality was low. The main methodological shortcomings of the studies were: no random allocation procedure, lack of prestratification on prognostic determinants, no blinding, small sample sizes, and lack of proper analysis and presentation of results. There was variability in the indication for implantation, implantation procedure, rate and volume of silicone microimplants. The use of different outcome measures in most of the trials made comparison between studies difficult. CONCLUSIONS: Because of the low methodological quality of included studies, results should be interpreted with caution and no firm conclusions about the efficacy of silicone microimplants were possible. Randomized clinical trials, using valid and reliable subjective and objective measurements, are necessary to establish the efficacy of silicone microimplants therapy in treating stress urinary incontinence in adult women.

Quality of life, functional outcome and durability of the AMS 800 artificial urinary sphincter in patients with intrinsic sphincter deficiency.

OBJECTIVE: To evaluate the quality of life, functional outcome and durability of the AMS 800 artificial urinary sphincter (AUS) in patients with urinary incontinence due to intrinsic sphincter deficiency of mixed origin. PATIENTS AND METHODS: Between 1991 and 2000, 34 AUS were implanted in 31 patients (24 males/7 females) with mean age of 59 (range 15-75) years. Using a questionnaire, patients' urinary function and quality of life were assessed in 22 patients with an AUS in situ. To evaluate efficacy and durability of the device, the primary adequate function (P-AF) and additional procedure-assisted adequate function (APA-AF) rates were determined on the basis of a Kaplan-Meier survival analysis. RESULTS: The social continence rate (0-1 pads/24 h) was 55% with a mean follow-up of 46 months. The revision rate was 26% and the explantation rate 35%. The 5-year P-AF and APA-AF rates were 41 and 44%, respectively. The pad score decreased from 2.95 to 1.23 after AUS implantation (p < 0.0001) leading to a high mean patient satisfaction (rated as 4.0 on a visual analog scale of 0-5). Twenty-one patients (95%) would undergo the procedure again under the same circumstances. Patients with previous anti-incontinence procedures showed a significantly higher explantation rate (p = 0.004). CONCLUSION: In spite of a relatively high re-operation rate and moderate social continence state, patient satisfaction was found to be great mainly due to the relative improvement in incontinence. The AMS 800 AUS is a reliable device with few mechanical complications. Extensive preoperative counseling is mandatory.