Is the anchor matter? A short-term follow up of the effect of mini-invasive mid urethra sling without anchor for urinary incontinence women

chang c1, horng h1, wang p2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 792
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Female Incontinence Surgery
1.Attending physician, Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taiwan, 2.Professor and Chairman, Department of Obsterics and Gynecology, Taipei Veterans General Hospital
Links

Abstract

Hypothesis / aims of study
Stress urinary incontinence is a common disease and the number of women who will undergo stress urinary incontinence (SUI) surgery is estimated to increase by 47.2% from 210,700 in 2010 to 310,050 in 2050[1]. During the last decade, the accepted standard technique has been the mid‐urethral sling operation. And minimal invasive sling surgery was suggest due to some side effects such as bladder perforation caused by tape insertion, erosion of the tape into the urethra during the healing period, pelvic hematomas, difficult voiding due to too tight of the sling or chronic thigh/groin pain [2]. Therefore, minimal invasive surgery was suggest and sling length was shorten to decrease the risk of bladder perforation, vessels damage or groin pain. Moreover, the prickle-like tips at the two edges was shift to pocket like end for the same purpose which called Needleless system with the purpose of creating less tissue damage during surgery and less foreign body reaction after surgery.  We want to present the effect of this sling surgery in our country.
Study design, materials and methods
We collect USI patients’ data from Nov, 2017 to Jan, 2019 who accepted Needleless sling surgery. Any perioperative complications were monitored. Assessments during the preoperative period and postoperative weeks 2, weeks 4 or later were done by two different gynecologists experienced in the urogynecology field. Every complaint was categorized in the postoperative period by the examining surgeon using a category-time-site-pain code following the ICS/IUGA Complication Classification Code guidelines [3].
Results
There are total 38 patients with average age was 66.3 years old, average parity was 2.8 and most of them were delivered by NSD. The average BMI was 25.6 and most of them were under menopausal status. The objective and subjective cure rate after 2 weeks follow up was 97.37% and 89.47 % separately. And decreased to 94.74% for objective cure rate and 89.47% for subjective cure rate after 4 weeks or longer OPD follow up.(Table 1) The average follow up time was 7.26 months with 6 patients have complications according to Complication Classification Code guidelines.(Table 2) In our study, although there are four patients complaint about difficult empty, slow flow or urinary retention, only one of them accepted sling cut surgery rather than total sling revision. And the other three patients were subsided after months of follow up. There are two patients complaint pelvic pain during physical activities and one of them refused pain killer for treatment. There is only one patient accepted re-operation with OBTRYX for persisted urine incontinence after Needleless surgery. According to the mentioned above, the failure rate is about 5.3% (n=2). Interestingly, there are 12 patients suffered from frequency and urge incontinence or even nacturia after the sling surgery and eight of them under medical control, four patients subsided after two weeks OPD follow up. Only two of the eight patients have the same symptoms before surgery. Therefore, de novo OAB rate is about 15.8% (n=6). Some cases of OAB after sling surgery are known complications that should be recognized promptly and corrected, including urinary tract infection, urinary tract foreign body, and bladder outlet obstruction and may be the last one is the main reason for the patients in our study.
Interpretation of results
Although in our series the follow-up was relatively short and the number of patients was limited, this single-incision procedure demonstrated promising data for improve quality of life and satisfied cure rate. But further study with larger prospective, randomized, comparative trials with other tension-free procedures and mini-sling systems is needed.
Concluding message
Single-incision procedure without anchor seems be able to improve patient’s quality of life with satisfied cure rate. We can offer patients with urinary incontinence more choices for treating product. Furthermore, it is the first article of Needleless system to analyze local data in our country and can be used as a starting point for further studies of this single-incision sling.
Figure 1 Table 1 postoperative cure rate
Figure 2 post-operation complications
References
  1. Wu J, et al. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol. 2011;205:230.e1–5.
  2. Novara G, Galfano A, Boscolo-Berto R. Complications rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and a meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol. 2008;53:288–309.
  3. Haylen B, et al. An international urogynecological association (IUGA)/international continence society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourol Urodyn. 2011;30:2–12.
Disclosures
<span class="text-strong">Funding</span> nil <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> the Institutional Review Board of Taipei Veterans General Hospital(IRB no. 2014-08-006CC) <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes