C-Clamp Technique: A Retrospective Review of a Novel Technique to Prevent Bladder Injury in Retropubic Midurethral Slings

WHY THIS MATTERS

There are more publications for synthetic mesh midurethral slings than any other surgical procedure in gynecology. The safety and efficacy have been clearly documented. The retropubic sling is the consensus criterion-standard treatment for stress urinary incontinence with urethral hypermobility. To date, however, a standardized technique to eliminate bladder injury has not been developed.

Simply Stated

The novel C-clamp technique is a standardized reproducible procedure to implant a bottom-up retropubic synthetic mesh midurethral sling that addresses key anatomic issues that may contribute to iatrogenic bladder injury. This retrospective review of 201 consecutive patients without a bladder injury using this novel technique supports this opinion.

Urinary incontinence affects approximately 50% of women during their lifetimes with the potential to significantly compromise their physical, mental, and economic health.1 Stress urinary incontinence (SUI) is the most common type, comprising 30–80% of urinary incontinence cases.1 Based on the Integral Theory2 reported in 1990, the synthetic mesh midurethral sling was introduced in 1995 to treat SUI in women. The original technique described placing the sling with a retropubic approach and recognized iatrogenic bladder injury at the time of placement. Since its introduction, the synthetic mesh midurethral sling has had more publications in the medical literature than any other surgical procedure in gynecology, and many experts believe it is the consensus criterion-standard treatment for SUI with urethral hypermobility.1 Since 1995, however, various modifications to the synthetic mesh midurethral sling have been developed at least in part to minimize bladder injury at the time of implantation. The primary modification attempting to reduce the risk of bladder injury has been to eliminate the retropubic approach altogether. None of the modifications, however, have eliminated the risk of bladder injury at the time of implantation.

The literature supports a bladder injury rate from 0.7% to 34% with the retropubic approach.3 Iatrogenic bladder injury results in morbidity, which can be significant. Women with lower urinary tract injury recognized on intraoperative cystoscopy at the time of synthetic mesh sling placement usually require discharge home with prolonged use of an indwelling Foley catheter, and intraoperative detection of bladder injury could result in abandoning the procedure all together. In addition, iatrogenic bladder injury may result in increased postoperative pain, urinary retention, urinary tract infections, and retropubic hematoma.4,5 Unrecognized bladder perforation can lead to postoperative dysuria, recurrent urinary tract infections, urinary frequency, urgency, pelvic pain, and bladder calculi on exposed sling material. Unrecognized iatrogenic bladder injury requires additional revision surgery with at least partial mesh sling removal and can result in a return of SUI.6

Long-term subjective cure rates for the retropubic synthetic midurethral sling range from 51% to 88% with modifications having similar but arguably lower cure rates.1 Limited long-term data suggest that the need for repeat surgery is more likely in transobturator slings than retropubic slings.1 A recent review also indicated that, over a lifetime, retropubic synthetic mesh midurethral slings are both less costly and more effective.7

Although studies support the increased long-term effectiveness of the retropubic synthetic mesh midurethral sling, especially when intrinsic sphincteric deficiency is identified, many surgeons choose a transobturator approach due to a perceived decreased risk of intraoperative bladder perforation. To date, there are no publications describing a step-by-step approach to place a synthetic mesh midurethral sling that eliminates the risk of bladder injury at the time of implantation. Previous studies have examined the benefit of standardized surgical techniques on operative times and surgical complications. In Atul Gawande's8 book, Complications, he described an institution that standardized the repair of inguinal hernias and noted a 4-fold decrease in hernia recurrence. In an attempt to eliminate the risk of iatrogenic injury when placing a synthetic mesh midurethral sling with the retropubic approach, the lead author developed a novel “C-clamp technique” that addresses the key factors believed to result in bladder injury from the retropubic approach.

METHODS

This study was determined exempt or excluded from institutional review board oversight in accordance with current regulations and institutional policy by HCA Healthcare (reference no. 2022-074). Patients who underwent placement of a retropubic synthetic mesh midurethral sling via the C-clamp technique (detailed in Fig. 1 and illustrated in the supplementary video, https://links.lww.com/FPMRS/A362) were identified by Current Procedural Terminology code in the electronic medical record of 1 health care provider as part of a quality improvement retrospective chart review. Medical records were reviewed for demographic and clinical data for all bottom-up retropubic synthetic mesh midurethral slings placed. The primary objective was to determine the rate of bladder injury at the time of retropubic synthetic mesh midurethral sling placement using the novel C-clamp technique. The secondary objective was to determine the rate of urethral injury at the time of retropubic synthetic mesh midurethral sling placement using the C-clamp technique.

F1FIGURE 1:

C-clamp technique.

RESULTS

Two hundred one consecutive bottom-up retropubic synthetic mesh midurethral slings placed using the C-clamp technique were identified from April 2012 through June 2022 (Table 1). The average age was 51 years (29–86 years); the average weight was 82 kg (46–139 kg); and the average body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) was 31 kg/m2 (15–57 kg/m2). The type of incontinence and intrinsic sphincter function was also specified: 103 women had SUI; 95 women had mixed urinary incontinence; 201 women had urethral hypermobility; and 95 women had intrinsic urethral sphincter insufficiency. Multiple patients had additional surgical procedures performed at the time of sling placement, including 53 women with concomitant hysterectomy and 75 women with concomitant vaginal prolapse repair. Data collected showed 89 women had a history of a prior hysterectomy; 27 women had a prior prolapse repair; 26 women had prior sling replacement and removal; and 4 women had prior retropubic colposuspensions. Thirty-four women had at least 1 prior cesarean delivery, and 129 women had prior abdominal surgery, including abdominal cosmetic surgery. One hundred ninety slings were manufactured by Johnson & Johnson (Somerville, NJ), and 11 were manufactured by Boston Scientific (Minnetonka, MN). No patients sustained a bladder or urethral injury at the time of implantation of a retropubic synthetic mesh midurethral sling using the C-clamp technique.

TABLE 1 - Patient Characteristics Average age, y 51  Range 29–86 Average weight, kg 82  Range 102–306 Average BMI, kg/m2 31  Range 15–57 Current tobacco smokers 17 (8.5%) SUI present 103 (51.2%) MUI present 95 (47.3%) Type of incontinence not recorded 3 (1.5%) Urethral hypermobility present 201 (100.0%) ISD present 95 (47.3%) Surgical history  Prior hysterectomy 89 (44.3%)  Prior prolapse repair 27 (13.4%)  Prior sling placement 26 (12.9%)  Prior sling removal 22 (10.9%)   Retropubic sling 1 (0.5%)   Obturator 13 (6.5%)   Other 8 (4.0%)  Prior Burch/other retropubic colposuspension 4 (2.0%)  1 Prior cesarean delivery 34 (16.9%)  Prior abdominal surgery* 129 (64.2%) Concomitant surgery at time of sling  Hysterectomy 53 (26.4%)  Prolapse repair 75 (37.3%) Sling type  Johnson & Johnson 190  Boston Scientific 11

*Prior abdominal surgery including abdominal cosmetic surgery.

BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); ISD, intrinsic sphincter deficiency; MUI, mixed urinary incontinence; SUI, stress urinary incontinence.


DISCUSSION

This retrospective chart review suggests that a retropubic synthetic mesh midurethral sling can be placed with a bottom-up C-clamp technique without risk of iatrogenic intraoperative bladder or urethral injury. Although bladder and urethral injury, when recognized at the time of implantation, can be immediately addressed by the surgeon with favorable long-term outcomes, both are complications that experts in urogynecologic surgery should marshal every technique and skill to avoid.

This study shows that, regardless of age, weight, BMI, type of incontinence, prior anti-incontinence procedure, prior cesarean delivery, prior gynecologic surgery, or concomitant gynecologic surgery, retropubic synthetic mesh midurethral sling placement with the novel C-clamp technique can result in a 0% bladder or urethral injury rate. The authors theorize that the novel C-clamp technique described in this review addresses female pelvic anatomy with surgical techniques that mobilize vital structures away from the path of trocar and sling placement, essentially eliminating the risk of bladder and urethral injury. Current literature does not describe a standardized approach to eliminate bladder and urethral injury when placing a retropubic synthetic mesh midurethral sling. The authors opine that the steps outlined for the novel C-clamp technique are simple, reproducible, and teachable. As data suggest superiority of long-term efficacy using the retropubic approach in comparison to alternative routes, the C-clamp technique may be a means to increase the use of the retropubic approach by removing the current deterrent to its use: fear of urinary tract injury.

Strengths of this study include the description of the novel C-clamp technique, detailed in the operative reports and this article, which can be rationalized anatomically as the reason for the primary and secondary outcomes. In addition, the patient data points evaluated represent a cross-section of women regularly seen by experts in female pelvic reconstructive surgery. The extremes of data points in the categories of age, weight, and BMI show that the novel C-clamp technique is applicable to most women with an expectation of eliminating iatrogenic bladder and urethral injury. Experts in female pelvic reconstructive surgery also treat women with prior surgical interventions and place slings concomitantly with other pelvic surgery, and again, none of these parameters altered the primary or secondary outcomes. An additional strength is the 10-year span of the review.

Limitations of this study include that it is a retrospective chart review of 1 implanting surgeon's office electronic medical record. In addition, the overwhelming majority of slings placed were from 1 manufacturer. Data collection was also limited by a change in electronic medical record ownership related to employment that may have resulted in incomplete enrollment; however, the index surgeon testifies to the same outcomes historically.

CONCLUSION

This study analyzed the outcomes of 201 consecutive retropubic bottom-up synthetic mesh midurethral slings placed over a 10-year span. The authors opine that the novel C-clamp technique addresses key anatomic issues that contribute to bladder and urethral injury when placing a retropubic bottom-up synthetic mesh midurethral sling, regardless of a wide range of metrics, and has the potential to eliminate bladder and urethral injury. This retrospective chart review represents a cross-section of women commonly seen by female reconstructive pelvic surgeons. These initial results are promising, and the authors feel that they can be applied to all women with SUI desiring surgical management. The authors opine that the steps for the novel C-clamp technique are reproducible and teachable and have the potential to set the standard for retropubic implantation of a bottom-up synthetic mesh midurethral sling.

Moving forward, future evaluation of the novel C-clamp technique with additional surgeons, as well as other manufacturers' retropubic slings, will strengthen the validity of these findings and the opinions shared by the authors. In addition, long-term data involving these primary and secondary outcomes, as well as other recognized longer-term outcome measures, could provide more data to support this technique. If those data prove favorable, they could support the C-clamp technique as the preferred standardized implantation technique for the bottom-up retropubic synthetic mesh midurethral sling.

REFERENCES 1. Ford AA, Rogerson L, Cody JD, et al. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2017;7(7):CD006375. doi:10.1002/14651858.CD006375.pub4. 2. Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand Suppl 1990;153:7–31. 3. Stav K, Dwyer PL, Rosamilia A, et al. Risk factors for trocar injury to the bladder during mid urethral sling procedures. J Urol 2009;182:174–179. doi:10.1016/j.juro.2009.02.140. 4. Zyczynski HM, Sirls LT, Greer WJ, et al. Findings of universal cystoscopy at incontinence surgery and their sequelae. Am J Obstet Gynecol 2014;210(5):480.e1–480.e8. doi:10.1016/j.ajog.2013.12.040. 5. Ras L, Roskam SFN, Kruger PF, et al. Retrospective review of intra- and post-operative complications with minimal versus large space of Retzius infiltration at the time of retropubic TVT placement. Int Urogynecol J 2019;30:743–751. doi:10.1007/s00192-018-3730-3. 6. Foley C, Patki P, Boustead G. Unrecognized bladder perforation with mid-urethral slings. BJU Int 2010;106:1514–1518. doi:10.1111/j.1464-410X.2010.09378.x. 7. Brazzelli M, Javanbakht M, Imamura M, et al. Surgical treatments for women with stress urinary incontinence: the ESTER systematic review and economic evaluation. Health Technol Assess 2019;23(14):1–306. doi:10.3310/hta23140. 8. Gawande A. Complications: A Surgeon's Notes on an Imperfect Science. New York: Picador; 2002.

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