Synthetic Mid-urethral Sling Procedures Research Articles

The impact of the 2011 US Food and Drug Administration transvaginal mesh communication on utilization of synthetic mid-urethral sling procedures

We sought to examine the change in utilization of the midurethral sling (MUS) for the treatment of stress urinary incontinence (SUI) after the 2011 US FDA communication regarding transvaginal mesh. This is a retrospective cohort study evaluating surgical utilization of MUS at a managed care organization of 4.5 million patients from 2008 to 2016. The primary outcome was the change in utilization of synthetic mesh MUS before and after the July 2011 FDA communication. Secondary outcomes were the changes in surgeon level MUS utilization. MUS procedures decreased from 131 to 116 per 100,000 adult women with a decrease of 11.5% from 2010 to 2012. Year over year utilization of MUS was rapidly increasing (p < 0.01) prior the FDA communication from 116 (in 2008) to 131 (in 2010) per 100,000 women and then significantly declined (p < 0.01) after its release from 135 (in 2011) to 75 (in 2016) per 100,000 women (13% increase vs 44% decrease). The number of surgeons performing MUS increased (p < 0.01) from 172/year to 186/year from 2008 to 2010 (Table 1). This decreased (p < 0.01) from 183/year to 121/year from 2011 to 2016. MUS for SUI drastically declined after the FDA communication. Despite the 2011 FDA communication concerning only transvaginal mesh for pelvic organ prolapse, there was a significant decrease in MUS with synthetic mesh utilization. Our findings support the importance of continued long-term outcome data regarding the safety and efficacy of MUS and highlight the impact of the FDA warning on MUS utilization.

Surgical Treatment of Female Stress Urinary Incontinence: Pubovaginal Slings

Autologous tissue has been used for pubovaginal sling construction for over a century. Compared with synthetic materials, fascial harvest carries additional and expected morbidity. However, by the nature of its definition, the use of autologous tissues is not associated with a significant immunogenic or any foreign body response. Randomized controlled trials have demonstrated and confirmed the durability of these procedures when compared with both colposuspensions and synthetic midurethral sling procedures. In light of the recent FDA warning regarding the use of synthetic materials for stress incontinence and pelvic organ prolapse surgery, the role of the autologous sling may be more prominent going forward. As such, the autologous pubovaginal sling remains a standard of care for the management of female stress urinary incontinence. This review contains 6 figures and 30 references Key words: autologous rectus fascia, complications, outcomes, pubovaginal sling, randomized controlled trials, stress urinary incontinence

Teaching mid-urethral sling surgery to residents: Impact on operative time and postoperative outcomes.

The purpose of this study was to determine the impact of resident teaching on outcomes of mid-urethral sling surgery. A retrospective review of female patients who underwent an outpatient transobturator (TOT) synthetic mid-urethral sling procedure with and without concomitant prolapse repair by two surgeons (JA, KE) in a tertiary female pelvic medicine practice was performed. Total procedure time (TPT = time from incision to closure including sling placement and any prolapse procedure), estimated blood loss (EBL), and postoperative complications including urinary retention, mesh exposure, reoperation, vaginal bleeding, and leg pain were compared between cases with and without the presence of a resident. One hundred thirty-four women underwent an outpatient transobturator sling procedure. Fifty-seven patients (43%) had a concomitant prolapse procedure. A resident was present at 57% (76/134) of cases. The average observed TPT (±SEM) was 60.6 ± 3.1 min when a resident was present and 46.6 ± 2.5 min when a resident was not present (P = 0.001). However, residents were more likely to be present when concomitant procedures were performed (P = 0.003). After adjusting for this, the presence of a resident increased TPT by an estimated 7.9 ± 2.5 min (P = 0.002). There was no statistical difference in EBL or postoperative complications. Resident participation in transobturator sling procedures resulted in a statistically significant, although clinically small, increase in operative time and had no significant impact on EBL or postoperative complications.

Efficacy and perioperative safety of synthetic mid-urethral slings in obese women with stress urinary incontinence

Obesity is associated with an increased prevalence of female stress urinary incontinence (SUI). Mid-urethral polypropylene sling is considered the surgical gold standard for treatment of SUI. We reviewed the current literature on efficacy at 1 year (or more) and perioperative safety of synthetic mid-urethral sling procedures for SUI in obese women. A systematic search of PubMed, Embase and the Cochrane databases was performed using the MeSH terms "Stress urinary incontinence", "Overweight", "Obesity" and "Surgery". We included 13 full-text papers published from January 1995 to May 2014. We defined two groups of women: non-obese (BMI below 30 kg/m(2)) and obese (BMI above 30 kg/m(2)). Data regarding subjective and objective cure and selected perioperative complications were pooled and compared. The pooled data from the 13 studies showed that 76.4% and 74.7% of non-obese and obese women, respectively, were subjectively cured (p = 0.70), and 83.3% and 79.2%, respectively, were objectively cured (p = 0.56). Bladder perforation was more frequently reported in non-obese women (p < 0.01). We did not detect a significant difference in postoperative urine retention or sling excision between the two groups (p = 0.36 and p = 0.17, respectively). Cure rates were found to be comparable in obese and non-obese women. Perioperative complications were not reported to occur more often in obese women. The outcomes of sling procedures for SUI appear to be comparable in obese and non-obese women, and counselling of obese women regarding outcomes and perioperative complications can be similar.

Recurrent stress urinary incontinence after synthetic mid-urethral sling procedures

Synthetic mid-urethral slings (MUSs) have been widely adopted for female stress urinary incontinence (SUI). Practitioners are encountering increasing numbers of women with recurrent SUI after a failed MUS. Several studies over the past 18 months have reported outcomes for secondary continence procedures in this context and form the basis of this review. Expert consensus supports a trial of conservative therapy for recurrent SUI, although a sound evidence base is lacking. As regards repeat surgical intervention, retrospective studies on repeat synthetic MUSs have demonstrated medium-term cure rates of 60-70%, which is lower than that achieved with primary surgery. Secondary transobturator tape appears inferior to secondary retropubic tape in women with intrinsic sphincteric deficiency. Promising early results have been reported with spiral slings and the adjustable continence procedures, although these interventions are technically more challenging and longer-term follow-up is warranted. Artificial urinary sphincters show high efficacy rates for severe, refractory SUI, although complication rates are higher in women with prior failed MUS. Repeat synthetic MUSs are likely to form the mainstay of secondary continence procedures presently. Longer-term follow-up of promising newer modalities, including adjustable continence therapies, is required. Above all, there is an urgent need for good quality, prospective data to guide practitioners in this growing clinical challenge.

Force of Stream After Sling Therapy: Safety and Efficacy of Rapid Discharge Care Pathway Based on Subjective Patient Report

We evaluated the safety of a mid urethral sling postoperative care pathway using patient subjective reporting of force of stream to minimize length of stay and catheter placement. Women undergoing solitary mid urethral sling surgery were prospectively enrolled in our study. Force of stream after the sling therapy protocol consisted of retrograde bladder filling with 300 ml fluid within 1 hour after surgery. Patients rated force of stream compared to baseline on a visual analog scale. Those with a force of stream of 50% or greater were immediately discharged home regardless of post-void residual urine volume. Only those unable to void and those rating force of stream less than 50% with post-void residual urine volume greater than 500 ml were discharged home with a catheter. Patients were telephoned within 1 week of surgery and seen 4 to 6 weeks postoperatively. The primary outcome was unexpected visits to the emergency room or office for voiding dysfunction or urinary retention. A total of 114 women were prospectively enrolled in our study, of whom 105 (92.1%) passed the protocol and were discharged home without a catheter. Of the patients 14 were discharged home with increased post-void residual urine volume (range 152 to 427 ml) but no catheter, representing those who would have been discharged with a catheter by many traditional voiding protocols. According to protocol 9 patients were discharged with a catheter. No patient presented to the emergency room or office in urinary retention or with voiding dysfunction before the scheduled visit. Patients who report a force of stream of 50% or greater can be safely and rapidly discharged home after an uncomplicated mid urethral sling procedure regardless of post-void residual urine volume. Scanned post-void residual urine volume does not add much value in those who can void. By following the force of stream after sling therapy protocol patients can be discharged home less than 3 hours after mid urethral sling surgery.

Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence

Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence

Repeat Synthetic Mid Urethral Sling Procedure for Women With Recurrent Stress Urinary Incontinence

We reported and compared the outcomes of repeat mid urethral sling with primary mid urethral sling in women with stress urinary incontinence. A total of 1,225 consecutive women with urodynamic stress incontinence underwent a synthetic mid urethral sling procedure (955 retropubic, 270 transobturator) at our institution between 1999 and 2007. Of the patients 91% (1,112) were interviewed via telephone call with a structured questionnaire and were included in the analysis. Mean +/- SD followup was 50 +/- 24 months (range 12 to 114). A comparison between repeat (77, mean age 62 +/- 12 years) and primary (1,035, mean age 60 +/- 13 years) mid urethral sling groups was performed. Repeat sling was placed without removal of the previous sling. The preoperative incidence of intrinsic sphincter deficiency was higher in patients who had a repeat mid urethral sling (31% vs 13%, p <0.001). The subjective stress incontinence cure rate was 86% and 62% in the primary and repeat group, respectively (p <0.001). The repeat retropubic approach was significantly more successful than the repeat transobturator approach (71% vs 48%, p = 0.04). The rates of sling related and general postoperative complications were similar between the primary and the repeat groups. However, de novo urgency (30% vs 14%, p <0.001) and de novo urge urinary incontinence (22% vs 5%, p <0.001) were more frequent in the repeat group compared with the primary group. A repeat synthetic mid urethral sling procedure has a significantly lower cure rate than a primary mid urethral sling procedure. The repeat retropubic approach has a higher success rate than the repeat transobturator approach. The incidence of de novo urgency and urge incontinence are significantly higher in repeat procedures.

Which type of mid‐urethral sling procedure should be chosen for treatment of stress urinary incontinance with intrinsic sphincter deficiency? Tension‐free vaginal tape or transobturator tape

To compare tension-free vaginal tape (TVT) and transobturator tape (TOT) for surgical treatment of stress urinary incontinence (SUI) with intrinsic sphincter deficiency. Retrospective study. Gynecology department, Bakirkoy Women and Childrens' Hospital, Istanbul. Three hundred women urodynamically diagnosed with stress incontinence with intrinsic sphincter deficiency underwent synthetic mid-urethral sling procedures (TVT = 180, TOT = 120). Before the operation, a complete medical history was taken and a gynecologic examination was performed. Subjects with detrusor overactivity or previous sling surgery were excluded. Clinical checkups were conducted at 3, 6, and 12 months, and then annually. Intraoperative complications, postoperative complications, and subjective cure rates. There were no significant differences in demographics between the TVT and TOT groups: mean age, parity, body mass index, menopausal status, and hormone replacement therapy. At a mean follow-up of 31.2 +/- 9.1 (range 12-46) months, the overall cure rates were 78.3% for TVT and 52.5% TOT (p < 0.0001). The risk of treatment failure in women who received TOT was 4.9 times higher than in women who underwent TVT. There were no significant differences in perioperative and postoperative complication rates between the two groups. TVT appears to be the preferable surgical option for the treatment of SUI with intrinsic sphincter deficiency.

Outcomes Following Repeat Mid Urethral Synthetic Sling After Failure of the Initial Sling Procedure: Rediscovery of the Tension-Free Vaginal Tape Procedure

We evaluated outcomes of the repeat mid urethral sling to treat recurrent or persistent stress urinary incontinence after failure of an initial mid urethral sling. We retrospectively analyzed data on patients who underwent the repeat mid urethral sling procedure due to persistent or recurrent stress urinary incontinence. Repeat slings were placed without removal of the previous sling. All patients were followed at least 1 year after the second mid urethral sling. Of the 31 female patients with a repeat mid urethral sling 29 were followed, including 13 with a retropubic and 16 with a transobturator sling. For the first mid urethral sling 17 patients received a retropubic sling (tension-free vaginal tape) and 12 received a transobturator sling (6 inside out and 6 outside in procedures). Cure and improvement rates irrespective of the approach were 75.9% (22 of 29 patients) and 6.9% (2 of 29), respectively. Cure rates for the retropubic and transobturator slings were 92.3% (12 of 13 patients) and 62.5% (10 of 16), respectively, a difference that did not quite attain statistical significance (p = 0.089). The repeat mid urethral sling for persistent or recurrent stress urinary incontinence has a lower cure rate than the initial sling. However, the retropubic approach tends to have a higher cure rate than the transobturator approach in repeat sling cases.

Transobturator Versus Transabdominal Mid Urethral Slings: A Multi-Institutional Comparison of Obstructive Voiding Complications

In the last year TO slings have become an increasingly popular alternative to TA slings for the surgical treatment of SUI. Proposed advantages of the transobturator approach include improved speed, safety and the reduction of obstructive complications. We assessed outcomes of TO and TA slings in a large series of women treated at several institutions to compare the rate of obstructive complications from these procedures. We reviewed the charts of 504 consecutive women who had synthetic mid urethral sling procedures (154 TO or 350 TA) performed by 24 different urologists for SUI at 8 institutions from 2002 to 2004. Obstructive complications were defined as increased PVR (greater than 100 cc), or the need for CIC, prolonged Foley catheter drainage or urethrolysis. While TO and TA sling procedures appeared to be similarly efficacious in eliminating the need for incontinence pad use (TO 89%, TA 86%, p = 0.36), the transobturator approach was associated with fewer obstructive complications (TO 11.0%, TA 18.3%, p < 0.05). Urethrolysis was required in none of the 154 TO cases and 8 of 350 (2.3%) TA cases. Concomitant pelvic surgery did not significantly increase the likelihood of obstructive voiding complications in either group. Although TO and TA sling procedures had similar short-term results for decreasing pad use in patients with stress urinary incontinence, the transobturator approach is associated with fewer obstructive voiding complications.