Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Dec 5:13:17562872211060909.
doi: 10.1177/17562872211060909. eCollection 2021 Jan-Dec.

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

Allert M de Vries  1 , Fenne M Casteleijn  2 , Jan-Paul W R Roovers  2 , John P F A Heesakkers  3 , Jurgen J Fütterer  4
Affiliations

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

Allert M de Vries et al. Ther Adv Urol. .

Abstract

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.

Keywords: computed tomography; stress urinary incontinence; urethral bulking agent; urolastic.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.M.d.V. reports non-financial support from Astellas Pharma BV, grants from Urogyn BV, during the conduct of the study; and family ties with former shareholders in Urogyn BV, Nijmegen, The Netherlands. J.P.W.R.R. reports consultancy at Coloplast, consultancy at Promedon, outside the submitted work; J.P.F.A.H. reports grants from Urogyn BV, during the conduct of the study; grants and personal fees from Astellas, grants from Bluewind, personal fees from Pierre Fabre, personal fees from Ixaltis, outside the submitted work. F.M.C. and J.J.F. have no conflict of interest to disclose.

Figures

Figure 1.
Figure 1.
Urolastic-procedure and injection positions. Paraurethral injection of VDPDMS at 2, 5, 7, and 10 o’clock position at the level of the mid-urethra using applicator (1) and applicator support (2). The two components are combined in the static mixer (3).
Figure 2.
Figure 2.
Urolastic hardware. Application gun (1) syringe with two components (2) static mixer with needle (3) different sizes of applicators (4).
Figure 3.
Figure 3.
Defining the plane with most VDPDMS present. Schematic sagittal view of the bladder and urethra (left) and a cross-section (right) in the plane with most VDPDMS present, divided into two quadrants.
Appendix 2.
Appendix 2.
Appearance of VDPDMS on CT after treatment. (a–c) Coronal images, (d) coronal image with VDPDMS following anatomy, (e, f) coronal images with spreading, (g–i) axial images, (j, k) axial images with spreading, (l) coronal image with spreading, and (m–o) sagittal view.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Burkhard FC, Bosch J, Cruz F, et al.. EAU-guidelines on urinary incontinence in adults 2018, https://uroweb.org/wp-content/uploads/EAU-Guidelines-on-Urinary-Incontin...
    1. Chapple CR, Cruz F, Deffieux X, et al.. Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence. Eur Urol 2017; 72: 424–431. - PubMed
    1. Kirchin V, Page T, Keegan PE, et al.. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev 2017; 7: CD003881. - PMC - PubMed
    1. de Vries AM, Venema PL, Heesakkers JPFA. Midurethral support is also necessary for reflex closure of the urethra. Neurourol Urodyn 2018; 37: 2965–2972. - PubMed
    1. Zajda J, Farag F. Urolastic for the treatment of women with stress urinary incontinence: 24-month follow-up. Cent European J Urol 2015; 68: 334–338. - PMC - PubMed