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Synthetic Sling for Index Patients with Stress Urinary Incontinence
Opposing Views
Synthetic Sling for Index Patients with Stress Urinary Incontinence THE CORRECT CHOICE IN 1995 Ulmsten et al introduced the tension-free vaginal tape procedure in which woven ProleneÒ tape is positioned “without fixation” and in a “tension-free manner” at the level of the “mid urethra” restoring support to the urethra and reinforcing pubourethral ligaments.1 The surgery was described as an “ambulatory 22 minute procedure” conducted with the patient under local anesthesia and, more importantly, it reached a clinical success equivalent to that reported with the Burch procedure, with a cure rate of 84% at 2 years postoperatively.1 Since 1995 mid urethral slings (MUS) have been continuously enhanced and many new innovations have surfaced to further improve the safety and effectiveness of the procedure to make it less invasive. Mid urethral slings are made of sterile, biocompatible, noncarcinogenic, macroporous, monofilament type I polypropylene mesh that is consistent in quality. The mesh allows for tissue in-growth without the need for suturing, is a proven material with a long history of implantation and clinical success, is nonreactive in vivo, fosters rapid tissue in-growth, and minimizes the risk of chronic inflammation and infection.2 Patient and physician benefits of MUS include durable efficacy and substantial outcomes data, minimally invasive, enhanced patient experience, versatile and effective for all types of stress urinary incontinence (SUI), low morbidity and/or complications and endorsed by professional society and national guidelines The mid urethral sling is the most studied surgical treatment for SUI in history with more than 2,000 published articles. Numerous randomized controlled trials (RCTs) and meta-analyses comparing types of slings, as well as comparing the sling procedure to other established SUI procedures have consistently demonstrated its clinical effectiveness.3,4 A Cochrane review of 62 trials concluded that MUS are as effective as the Burch surgery.3 MUS are as effective as fascia slings but MUS require shorter operating time, less voiding dysfunction and less de novo urge. A recent systematic review of RCTs with minimum 12-month
0022-5347/15/1941-0018/0 THE JOURNAL OF UROLOGY® © 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
18
j
www.jurology.com
AND
RESEARCH, INC.
followup revealed no significant difference between MUS and Burch with regard to objective or subjective cure rate, quality of life or sexual function.4 Thus, either intervention was recommended balancing potential adverse events and concomitant surgeries. In regard to MUS vs pubovaginal slings subjective cure favored MUS. A key benefit of MUS is the enhanced overall patient experience. These operations are minimally invasive and are often performed under intravenous sedation and/or local anesthesia. MUS result in less blood loss, shorter hospital stay and less postoperative pain.3,4 Today’s procedures last approximately 30 minutes, allowing the majority of patients to void spontaneously soon after surgery and be discharged home without a catheter. There is minimal use of postoperative analgesia with quick return to activity of daily living. Another advantage of the mid urethral sling is its versatility. In addition to the index patient with SUI, a broad evidence base supports the effectiveness and use of MUS in obese or elderly patients, after failed prior surgery and in patients with intrinsic sphincter deficiency with concurrent prolapse repair.5 MUS are contraindicated in patients with SUI and a urethrovaginal fistula, urethral erosion, intraoperative urethral injury and/or urethral diverticululm.5 Review of RCTs revealed low morbidity and complications from MUS. The risk of transfusion, hematoma formation, wound infection, bowel injury, short and long-term retention, and deep venous thrombosis rates are all lower for the mid urethral sling than the pubovaginal sling or Burch procedure (see table).4 Mesh erosion or removal due to voiding dysfunction is a potential risk with MUS but several studies have indicated risk of sling revision/ removal to be less than 3.7%.1,3,4 The use of MUS for SUI is widely supported among several societies and guidelines. The AUA position statement on the use of vaginal mesh noted that efficacy is equivalent or superior to other surgical techniques and consequently concluded that MUS are an appropriate treatment choice for women with SUI, with similar efficacy but less
http://dx.doi.org/10.1016/j.juro.2015.04.063 Vol. 194, 18-20, July 2015 Printed in U.S.A.
OPPOSING VIEWS
Rates of adverse events by sling type from the literature4 % Obturator % Retropubic % Pubovaginal % Burch Transfusion Hematoma Wound infection Bowel injury Ureteral injury Retention less than 6 wks Retention greater than 6 wks Bladder perforation Deep venous thrombosis
0.17 0.59 0.74 0.0 1.2 2.3
0.4 0.88 0.75 0.34 0.0 3.1
1.9 2.2 2.6 0.18 12
0.0 1.4 7.0 3.13 0.6 17
2.4
2.7
7.5
7.6
0.7 0.0
3.6 0.6
2.3 0.35
2.8 0.58
morbidity than conventional nonmesh sling techniques. According to the European Association of Urology clinical practice guidelines, MUS should be offered to the index patient with SUI as the preferred surgical intervention when available.5 The Burch procedure or autologous fascial slings should be offered when MUS are contraindicated.5 Overall, there are many reasons a mid urethral sling is an appropriate choice for the patient with
19
SUI. The clinical benefit and durable efficacy from MUS have been significant. Compared to other surgical repairs, the minimal invasiveness of MUS allows for an enhanced patient experience with quick return to daily activities. MUS are associated with fewer perioperative complications than traditional vaginal and abdominal surgeries. Other than mesh exposure and erosion, which is extremely rare and manageable, complications are not unique to MUS, and surgeons must acknowledge, recognize and correct the problems when they arise. To mitigate these issues, surgeons should be appropriately prepared, communicate proper consent to the patient, perform the right surgery for the right patient and do it well. Lastly, several professional and national guidelines support the favorable benefit/risk profile, concluding that the mid urethral sling is the right choice for the index patient with SUI. Michael J. Kennelly McKay Urology Charlotte, North Carolina
REFERENCES 1. Ulmsten U, Henriksson L, Johnson P et al: An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996; 7: 81. 2. Dmochowski RR, Padmanabhan P and Scarpero HM: Slings: autologous, biologic, synthetic, and midurethral. In: Campbell-Walsh Urology Tenth Edition Review. Edited by WS McDougal,
AJ Wein, LR Kavoussi et al. Philadelphia: Elsevier Saunders 2012; chapt 73, pp 2115e2167. 3. Ogah J, Cody JD and Rogerson L: Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2009. Issue 4. Art. No.: CD006375. DOI: 10.1002/14651858. CD006375.pub2.
NOT THE CORRECT CHOICE SYNTHETIC mid urethral slings are the most commonly performed anti-incontinence procedures performed in women in the industrialized world. Their efficacy is comparable to historic gold standards, such as the autologous fascial sling and Burch colposuspension, and operating time, hospital stay and short-term morbidity are less. Most MUS surgeries are performed in the outpatient setting and, barring complications, the patient can return to daily activities within a matter of days. The American Urological Association, Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, and American Urogynecologic Society endorse synthetic MUS as safe and effective. With all of these attributes, it is easy to understand why, at last count, 87% of urologists consider MUS the procedure of choice for the index patient with stress incontinence.
4. Schimpf MO, Rahn DD, Wheeler TL et al: Sling surgery for stress urinary incontinence in women: a systematic review and meta-analysis. Am J Obstet Gynecol 2014; 211: 71.
5. Lucas MG, Bosch JLHR, Burkhard FC et al: EAU guidelines on surgical treatment of urinary incontinence. Eur Urol 2012; 62: 1118.
We disagree. We do not doubt the efficacy nor any of the aforementioned attributes but, safety, that’s the issue. In our judgment synthetic MUS have unique, serious and lifestyle altering complications that rarely, if ever, occur after the historic gold standards.1e3 Anyone who has ever had to dig mesh out of a bladder wall, repair a mesh fistula, explore the thigh for mesh or treat refractory groin pain can attest to how difficult these problems are to manage. Here is what Dunn et al wrote about mesh complications: The effects.caused both physical and emotional pain, in addition to the discomfort of the original pelvic floor dysfunction. ‘‘cascading health problems,’’. a spiral of health problems, anxiety, and desperation. In ‘‘settling for a new normal,’’ the women who once considered themselves healthy now believed that they are unhealthy and worked to adjust to their degraded health status. The women still symptomatic discharged from tertiary care clinic expressed hopelessness and abandonment.2
Synthetic Sling for Index Patients with Stress Urinary Incontinence THE CORRECT CHOICE IN 1995 Ulmsten et al introduced the tension-free vaginal tape procedure in which woven ProleneÒ tape is positioned “without fixation” and in a “tension-free manner” at the level of the “mid urethra” restoring support to the urethra and reinforcing pubourethral ligaments.1 The surgery was described as an “ambulatory 22 minute procedure” conducted with the patient under local anesthesia and, more importantly, it reached a clinical success equivalent to that reported with the Burch procedure, with a cure rate of 84% at 2 years postoperatively.1 Since 1995 mid urethral slings (MUS) have been continuously enhanced and many new innovations have surfaced to further improve the safety and effectiveness of the procedure to make it less invasive. Mid urethral slings are made of sterile, biocompatible, noncarcinogenic, macroporous, monofilament type I polypropylene mesh that is consistent in quality. The mesh allows for tissue in-growth without the need for suturing, is a proven material with a long history of implantation and clinical success, is nonreactive in vivo, fosters rapid tissue in-growth, and minimizes the risk of chronic inflammation and infection.2 Patient and physician benefits of MUS include durable efficacy and substantial outcomes data, minimally invasive, enhanced patient experience, versatile and effective for all types of stress urinary incontinence (SUI), low morbidity and/or complications and endorsed by professional society and national guidelines The mid urethral sling is the most studied surgical treatment for SUI in history with more than 2,000 published articles. Numerous randomized controlled trials (RCTs) and meta-analyses comparing types of slings, as well as comparing the sling procedure to other established SUI procedures have consistently demonstrated its clinical effectiveness.3,4 A Cochrane review of 62 trials concluded that MUS are as effective as the Burch surgery.3 MUS are as effective as fascia slings but MUS require shorter operating time, less voiding dysfunction and less de novo urge. A recent systematic review of RCTs with minimum 12-month
0022-5347/15/1941-0018/0 THE JOURNAL OF UROLOGY® © 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
18
j
www.jurology.com
AND
RESEARCH, INC.
followup revealed no significant difference between MUS and Burch with regard to objective or subjective cure rate, quality of life or sexual function.4 Thus, either intervention was recommended balancing potential adverse events and concomitant surgeries. In regard to MUS vs pubovaginal slings subjective cure favored MUS. A key benefit of MUS is the enhanced overall patient experience. These operations are minimally invasive and are often performed under intravenous sedation and/or local anesthesia. MUS result in less blood loss, shorter hospital stay and less postoperative pain.3,4 Today’s procedures last approximately 30 minutes, allowing the majority of patients to void spontaneously soon after surgery and be discharged home without a catheter. There is minimal use of postoperative analgesia with quick return to activity of daily living. Another advantage of the mid urethral sling is its versatility. In addition to the index patient with SUI, a broad evidence base supports the effectiveness and use of MUS in obese or elderly patients, after failed prior surgery and in patients with intrinsic sphincter deficiency with concurrent prolapse repair.5 MUS are contraindicated in patients with SUI and a urethrovaginal fistula, urethral erosion, intraoperative urethral injury and/or urethral diverticululm.5 Review of RCTs revealed low morbidity and complications from MUS. The risk of transfusion, hematoma formation, wound infection, bowel injury, short and long-term retention, and deep venous thrombosis rates are all lower for the mid urethral sling than the pubovaginal sling or Burch procedure (see table).4 Mesh erosion or removal due to voiding dysfunction is a potential risk with MUS but several studies have indicated risk of sling revision/ removal to be less than 3.7%.1,3,4 The use of MUS for SUI is widely supported among several societies and guidelines. The AUA position statement on the use of vaginal mesh noted that efficacy is equivalent or superior to other surgical techniques and consequently concluded that MUS are an appropriate treatment choice for women with SUI, with similar efficacy but less
http://dx.doi.org/10.1016/j.juro.2015.04.063 Vol. 194, 18-20, July 2015 Printed in U.S.A.
OPPOSING VIEWS
Rates of adverse events by sling type from the literature4 % Obturator % Retropubic % Pubovaginal % Burch Transfusion Hematoma Wound infection Bowel injury Ureteral injury Retention less than 6 wks Retention greater than 6 wks Bladder perforation Deep venous thrombosis
0.17 0.59 0.74 0.0 1.2 2.3
0.4 0.88 0.75 0.34 0.0 3.1
1.9 2.2 2.6 0.18 12
0.0 1.4 7.0 3.13 0.6 17
2.4
2.7
7.5
7.6
0.7 0.0
3.6 0.6
2.3 0.35
2.8 0.58
morbidity than conventional nonmesh sling techniques. According to the European Association of Urology clinical practice guidelines, MUS should be offered to the index patient with SUI as the preferred surgical intervention when available.5 The Burch procedure or autologous fascial slings should be offered when MUS are contraindicated.5 Overall, there are many reasons a mid urethral sling is an appropriate choice for the patient with
19
SUI. The clinical benefit and durable efficacy from MUS have been significant. Compared to other surgical repairs, the minimal invasiveness of MUS allows for an enhanced patient experience with quick return to daily activities. MUS are associated with fewer perioperative complications than traditional vaginal and abdominal surgeries. Other than mesh exposure and erosion, which is extremely rare and manageable, complications are not unique to MUS, and surgeons must acknowledge, recognize and correct the problems when they arise. To mitigate these issues, surgeons should be appropriately prepared, communicate proper consent to the patient, perform the right surgery for the right patient and do it well. Lastly, several professional and national guidelines support the favorable benefit/risk profile, concluding that the mid urethral sling is the right choice for the index patient with SUI. Michael J. Kennelly McKay Urology Charlotte, North Carolina
REFERENCES 1. Ulmsten U, Henriksson L, Johnson P et al: An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996; 7: 81. 2. Dmochowski RR, Padmanabhan P and Scarpero HM: Slings: autologous, biologic, synthetic, and midurethral. In: Campbell-Walsh Urology Tenth Edition Review. Edited by WS McDougal,
AJ Wein, LR Kavoussi et al. Philadelphia: Elsevier Saunders 2012; chapt 73, pp 2115e2167. 3. Ogah J, Cody JD and Rogerson L: Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2009. Issue 4. Art. No.: CD006375. DOI: 10.1002/14651858. CD006375.pub2.
NOT THE CORRECT CHOICE SYNTHETIC mid urethral slings are the most commonly performed anti-incontinence procedures performed in women in the industrialized world. Their efficacy is comparable to historic gold standards, such as the autologous fascial sling and Burch colposuspension, and operating time, hospital stay and short-term morbidity are less. Most MUS surgeries are performed in the outpatient setting and, barring complications, the patient can return to daily activities within a matter of days. The American Urological Association, Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, and American Urogynecologic Society endorse synthetic MUS as safe and effective. With all of these attributes, it is easy to understand why, at last count, 87% of urologists consider MUS the procedure of choice for the index patient with stress incontinence.
4. Schimpf MO, Rahn DD, Wheeler TL et al: Sling surgery for stress urinary incontinence in women: a systematic review and meta-analysis. Am J Obstet Gynecol 2014; 211: 71.
5. Lucas MG, Bosch JLHR, Burkhard FC et al: EAU guidelines on surgical treatment of urinary incontinence. Eur Urol 2012; 62: 1118.
We disagree. We do not doubt the efficacy nor any of the aforementioned attributes but, safety, that’s the issue. In our judgment synthetic MUS have unique, serious and lifestyle altering complications that rarely, if ever, occur after the historic gold standards.1e3 Anyone who has ever had to dig mesh out of a bladder wall, repair a mesh fistula, explore the thigh for mesh or treat refractory groin pain can attest to how difficult these problems are to manage. Here is what Dunn et al wrote about mesh complications: The effects.caused both physical and emotional pain, in addition to the discomfort of the original pelvic floor dysfunction. ‘‘cascading health problems,’’. a spiral of health problems, anxiety, and desperation. In ‘‘settling for a new normal,’’ the women who once considered themselves healthy now believed that they are unhealthy and worked to adjust to their degraded health status. The women still symptomatic discharged from tertiary care clinic expressed hopelessness and abandonment.2