The TVT Worldwide Observational Registry for Long-Term Data: Safety and Efficacy of Suburethral Sling Insertion Approaches for Stress Urinary Incontinence in Women

2011 ◽  
Vol 186 (6) ◽  
pp. 2310-2315 ◽  
Author(s):  
Douglas G. Tincello ◽  
Theunis Botha ◽  
Douglas Grier ◽  
Peter Jones ◽  
Dhinagar Subramanian ◽  
...  
2021 ◽  
Vol 9 (2) ◽  
pp. 64-73
Author(s):  
G. V. Kovalev ◽  
D. D. Shkarupa ◽  
N. D. Kubin ◽  
G. I. Nichiporuk ◽  
I. V. Gaivoronsky

Introduction. The implantation of a synthetic sub-urethral sling is the main method of surgical correction of stress urinary incontinence (SUI). However, the investigation results of long-term effectiveness indicate the ambiguity of the surgery outcomes. In addition, the problem of pain in the perineum remains relevant for everyday practice. One of the important aspects in this matter may be a variant technique for installing a suburethral sling, including based on the anatomical variability of the small pelvis.Purpose of the study. To identify key anatomical factors that can negatively affect the effectiveness and safety of the environment of suburethral sling surgery for urinary incontinence in women.Materials and methods. The study consisted of 2 parts - anatomical and clinical. In the anatomical part of the study, a suburethral sling was implanted on 20 preparations of a female pelvis with a lower limb and preserved soft tissues. The clinical part of the study involved 50 patients with stress urinary incontinence. These patients underwent installation of a transobturator suburethral sling in two ways using the “inside-out” technique: using the standard “external landmarks” technique and using the proposed anatomical technique developed in the first part of the study. After visualization of the suburethral sling using the original method, the outcomes of the operations were assessed depending on the location of the sling in the patient's tissues.Results. In the anatomical part of the study, the most atraumatic method of suburethral sling implantation was determined by rotating the tool around the lower branch of the pubic bone. In the clinical part of the study, this method demonstrated a higher efficiency of the operation at a follow-up of 1 year, presumably due to the U-shaped angle of the «hammock» for the urethra, which is characteristic of the retropubic sling.Conclusion. Outcomes of operations for SUI depend, among other things, on the method of the suburethral sling implantation.


Author(s):  
Gamal Ghoniem ◽  
Bilal Farhan ◽  
Mashrin Lira Chowdhury ◽  
Yanjun Chen

Abstract Introduction and hypothesis This study aimed to report 3-year completed follow-up of the safety and efficacy of Macroplastique® (MPQ) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Methods This is a retrospective analysis of all women who completed 3-year follow-up post-MPQ injection(s) at ten medical centers. We used the ROSE registry data report of Macroplastique® [Macroplastique® Real-time Observation of Safety and Effectiveness (ROSE) registry P040050/PAS001 on 2017]. Subjective incontinence outcome and adverse effects were assessed. Results The study included all patients (n = 70) who completed 3-year follow-up after the last MPQ injection. Twenty-four of 70 (34%) patients had two injections; 21/70 (30%) patients reported Stamey grade 0 and 28/70 (40%) reported Stamey grade 1. The overall patient satisfaction was 68% who completed 3-year follow-up. The composite success rate (I-QoL, PGI-S, and Stamey grade improvement) was 51.4%. No serious adverse events (AE) were reported within the completed 3-year follow-up. Conclusions MPQ was found to be safe and efficacious for the treatment of SUI secondary to ISD in women. The overall high satisfaction rate was sustained from baseline to 3 years post-injection. Most complications were minor and transient without sequelae.


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