Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study.

OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL.

Imaging findings of vinyl dimethyl polydimethylsiloxane used as a paraurethral injectable for female stress urinary incontinence.

OBJECTIVES: Vinyl dimethyl polydimethylsiloxane (VDPDMS) is a urethral bulking agent used for female stress urinary incontinence (SUI), that is clearly visible on computed tomography (CT). Clinical effects are promising, but it remains difficult to identify factors predicting clinical success. Clinical outcome might depend on the shape and position of the implants after injection. Objective of this study is to analyze the appearance and position of bulk material on CT scans and to see whether it is delivered the intended circumferential and mid-urethral position. METHODS: A single-center retrospective study was performed in 20 women, treated with VDPDMS for SUI. A senior radiologist analyzed all CTs, using an assessment scheme. This scheme describes whether the bulk is scattered, mid-urethral, and/or circumferentially distributed. The imaging findings were subsequently correlated to the patient global impression of improvement (PGI-I) and the percentage of subjective improvement experienced 6 weeks post-operatively. RESULTS: The patient's mean age was 61 years, and they underwent median 2.0 previous surgical treatments for SUI. Three patients reported no improvement, 9 patients had 20-90% improvement and 8 reported >90% improvement of their SUI. In 17/74 (24%) positions, the implant was scattered rather than spherical. In 9/20 (45%), the implants were not located in the intended mid-urethral position. In 8/20 patients (40%), the material was distributed circumferentially. CONCLUSION: This is the first study describing the position and shape of VDPDMS in patients after treatment. The appearance and position of the implants appears to be variable, but optimal positioning or shape seems to be no absolute requisite for success.

Midurethral support is also necessary for reflex closure of the urethra.

BACKGROUND AND OBJECTIVES: The pathophysiology of female stress urinary incontinence (SUI) is far from unraveled. Capturing all aspects of this bothersome condition in one theory remains challenging. The well-known Hammock and Integral theories, both from the early 90's, were successful in explaining a large proportion of the observations made in clinical practice. Nevertheless, some (pre)clinical observations cannot be explained by the current understanding. One of the issues concerns the pressure transmission. Is this process really a passive mechanical action, or is an additional active mechanism responsible for urethral closure? The finding that an increase in urethral pressure sometimes precedes and exceeds the increase in intravesical pressure suggests the latter. This concept has never been incorporated in one of the existing theories describing SUI. This is remarkable as a lot of evidence has been generated in recent years that proves involvement of active components. This review aims to provide an additional theory in which an active reflex closure mechanism of the urethra is incorporated. METHODS: Recent as well as older publications from clinical and animal studies are included to support the hypothesis. RESULTS: The smooth muscles of the urethra, the vascular bed, and the estrogen-influenced urethral mucosa, combined with striated muscle tone, contribute to the intra-urethral pressure. A passive transmission of force to the urethra exists only in the abdominal proximal third of the urethra. In the distal two thirds of the urethra an active closure mechanism is present, dependent on sufficient urethral support in the proper anatomical position. This active closure mechanism is generated by reflex contraction of striated muscles of the urethra and the pelvic floor. CONCLUSION: Continence is a result of passive as well as active urethral closure mechanisms. The most important factor in female continence seems to be the proper functioning of an active reflex urethral closing mechanism.

Contemporary diagnostics and treatment options for female stress urinary incontinence.

Stress urinary incontinence is not a deadly disease, but for the large population of women suffering from it, it is a very important issue. Especially in the continuously aging population all over the world, there is more and more need for treatment of this serious medical condition. Treatment of female stress urinary incontinence exists already for ages. In the 20th century invasive treatments like Burch colposuspension and pubovaginal slings were the mainstay of surgical treatments. The introduction of the midurethral sling made the procedure less invasive and accessible for more caregivers. Luckily there are many options available and the field is developing quickly. In recent years many new medical devices have been developed, that increase the number of treatment options available and make it possible to find a suitable solution for the individual patient based on subjective and objective results and the chances of complications. This manuscript provides an introduction to the therapeutical options that are available nowadays for female stress urinary incontinence.

Complications of Urethral Bulking Agents for Stress Urinary Incontinence: An Extensive Review Including Case Reports.

OBJECTIVES: Stress urinary incontinence in women is a common problem that significantly impacts quality of life. Periurethral injection of urethral bulking agents (UBAs) is a simple, noninvasive, and cost-effective treatment. However, complications associated with UBA are often underappreciated. Objective of this review was to get a complete overview of all published complications of UBA. METHODS: An extensive search of the scientific literature was conducted to quantitatively summarize the complications and their treatments of 8 UBAs. A total of 117 articles (original articles and case reports) were included in the final analysis. Complication incidence, treatment incidence, and follow-up time were extracted when mentioned. Statistical analysis of complication incidence of each UBA was calculated if possible. RESULTS: A total of 2095 complications in 6462 treated patients were reported in 79 studies. Sixty-seven (3%) were considered serious implying operative correction (Clavien grade III); of these, 46 (69%) required incision and drainage, and 21 (31%) required a more invasive procedure. In 38 case reports and small case series, 49 patients were treated for 110 complications. Of these 110 complications, 41 (37%) can be classified as Clavien grade III. CONCLUSIONS: This extensive review shows that various UBAs have different complication rates, with certain UBAs being more prone to serious complications. Based on available publications, most UBAs have a good safety profile, with low complication rates. However, although the majority of UBA complications are transient and require no or noninvasive treatment, serious complications may require invasive intervention and treatment.

Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety.

INTRODUCTION: Female stress urinary incontinence (SUI) is often treated surgically. Urethral bulking agents are a minimally invasive alternative, especially in patients suffering from intrinsic sphincter deficiency, but often with limited long-term efficacy. Urolastic® is a non-deformable, non-resorbable silicone elastomer that is used as an injectable. Its properties might result in a more durable response after injection. If this durability factor can be combined with a low complication rate, this can become a useful treatment option. We therefore assessed the subjective improvement and safety after treatment with Urolastic®. MATERIALS AND METHODS: In 2 Dutch hospitals, 65 patients were treated with Urolastic®. The subjective improvement was assessed and the medical charts were reviewed for complications that appeared during the follow-up period. The complications were classified using the Clavien-Dindo classification. RESULTS: We found that 76-88% of the patients showed subjective improvement at 12-25 months follow-up. The rate of improvement experienced was 50-70%. The rate of complications classified as Clavien-Dindo >II was 24-33%. The 12 patients with 75-100% subjective improvement after 2 months, showed 85% improvement after a median of 25 months. CONCLUSIONS: With careful patient selection, Urolastic® seems to be a safe, durable and effective treatment option for female SUI.