- Email: [email protected]
Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term Outcomes
Accepted Manuscript Title: Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term outcomes Author: Brian J. Linder, Daniel S. Elliott PII: DOI: Reference:
S0090-4295(16)30004-8 http://dx.doi.org/doi: 10.1016/j.urology.2016.03.025 URL 19704
To appear in:
Urology
Received date: Accepted date:
12-2-2016 17-3-2016
Please cite this article as: Brian J. Linder, Daniel S. Elliott, Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term outcomes, Urology (2016), http://dx.doi.org/doi: 10.1016/j.urology.2016.03.025. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term outcomes Brian J. Linder MD and Daniel S. Elliott MD
From the Department of Urology Section of Pelvic and Reconstructive Urology Mayo Clinic, Rochester, MN Running Title: Autologous transobturator sling outcomes Key Words: autologous, transobturator, urethral sling, female stress incontinence Abstract Word Count: 250 Manuscript Word Count: 2039 Number of Tables: 2 Number of Figure: 2
Disclosures and Conflict of interest: Brian Linder- None, Daniel Elliott- None Funding: None
Corresponding author: S. Elliott, MD 284-3983 Street SW MN 55905 [email protected]
Daniel Phone: 507200 First Rochester, Email:
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Page 1 of 15
Acknowledgements The authors would like to acknowledge the Mayo Clinic Department of Biomedical Statistics and Informatics for their assistance with the analyses in this study.
Abstract Objective: To evaluate short-term outcomes of autologous transobturator (ATO) urethral sling placement using rectus fascia for female stress urinary incontinence. Methods: We evaluated the outcomes of 33 consecutive females that underwent ATO sling placement with rectus fascia for stress incontinence from 2013-2014. Patients were seen at 3 months postoperatively and mailed a questionnaire at least one year after surgery for further follow-up. Outcomes were measured by ICIQ-FLUTS and compared between pre and postoperative responses using Wilcoxon Signed Rank test. Retreatment-free survival rates were evaluated via Kaplan-Meier method. Results: Median patient age was 62 years old (IQR 47.5;70.5) with a median BMI of 28.6 kg/m2 (IQR 24.7kg/m2; 32.4kg/m2). When isolated sling placement was performed, 88% (15/17) were outpatient procedures. Median follow-up was 14.9 months (IQR 3.6,18.7), during which five patients underwent repeat anti-incontinence surgery. For those without retreatment, 25/28 (89%) completed ICIQ-FLUTS at last follow-up. Compared to preoperative scores, patients who completed ICIQ-FLUTS questionnaires at 1-year or greater (N=18) showed significant improvement in all domains: frequency (p=0.007), voiding (p=0.02) and incontinence (p=0.004), and in quality of life related to frequency (p=0.008), voiding (p=0.002) and incontinence (p=0.01). Among those who completed questionnaires both at 3-month and at least 1 year after surgery (N=17), there was no significant deterioration in ICIQ-FLUTS scores. Overall
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retreatment–free survival rate was 92% at 1 year. Notably, no patients suffered severe (Clavien III-V) complications or required sling release. Conclusions: Autologous transobturator urethral sling placement appears safe, with promising short-term outcomes. Longer follow-up and external validation are needed.
Introduction Stress urinary incontinence (SUI) is a highly prevalent issue in adult women, and can have a large impact on quality of life.1 In fact, it was recently estimated that the lifetime risk of a woman undergoing surgery for SUI is as high as 13.6%.2 In contemporary samples, the most common surgery performed in the management of female SUI is the midurethral synthetic sling, given its efficacy and reduced perioperative morbidity, which allows it to be performed on an outpatient basis. 3, 4 Notably, as the population in the United States ages, it is estimated that the number of SUI procedures will substantially increase, by nearly 50% by 2050 in one report.5 While multiple reports describe that synthetic mid-urethral slings are safe, effective and supported by the combined SUFU/AUGS position statement and AUA guideline,6-8 many patients and providers remain in search of non-mesh alternatives in SUI surgery.9, 10 In fact, secondary to the initial Food and Drug Administration notification on mesh use in pelvic surgery, subsequent television litigation advertisements and information encountered on the internet, many patients presenting to Female Pelvic Medicine and Reconstructive Surgery clinics have a significant aversion to the use of mesh materials.11, 12 While several options outside of synthetic midurethal sling placement exist, such as the autologous pubovaginal sling, biologic
3
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grafts, or urethral bulking agent injection, each has its own limitations, whether related to morbidity or efficacy. While the autologous pubovaginal urethral sling offers an option for management of SUI outside of synthetic mesh placement, it is associated with a higher risk of postoperative voiding dysfunction.13, 14 Notably, with synthetic sling placement, the retropubic approach has also been associated with a higher rate of post-operative voiding dysfunction when compared to the transobturator approach. 14, 15 In an attempt to avoid the unique risks of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement, all while maintaining successful surgical outcomes, we proposed the feasibility of an autologous transobturator (ATO) urethral sling.16 Here, we evaluated the short-term outcomes of patients undergoing autologous transobturator urethral sling placement.
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Materials and Methods
Following Institutional Review Board approval we retrospectively evaluated the outcomes of 33 consecutive female patients that underwent ATO mid-urethral sling placement for the management of bothersome symptomatic SUI from 2013 to 2014. All patients were evaluated pre-operatively with a history and physical exam, urinalysis, urine culture, 24-hour pad weight, post-void residual measured by ultrasound and International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms score (ICIQ-FLUTS). Following discussion of the AUA guideline statements and available management options for female SUI 7 all patients wished to proceed with a transobturator approach to autologous midurethral sling placement. All procedures were performed by a single surgeon (DSE).
Our initial presentation of the surgical technique for ATO sling placement, including descriptive surgical video, have been reported.16, 17 Briefly, we perform an anterior wall vaginal dissection based on the mid-urethra, similar to that utilized with the synthetic transobturator procedure, with dissection carried laterally on each side to the obturator foramen. After evaluating the distance between the obturator foramen, an abdominal anterior rectus fascial sling harvest is performed to obtain a ~1 cm x ~5 cm segment of fascia. Two stay sutures are secured to corner of the fascial segment on each side. Next, two separate trocar passages are performed on each side, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. For this, we prefer to use a reusable C-shaped trocar that was designed at our institution. Following this, the stay sutures are tied external to the obturator membrane, leaving the sling secured and flush with the urethra. Sutures are also
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placed to secure the sling to the periurethral tissue to prevent rolling or migration. A representative illustration of these steps is shown in Fig 1.
The ATO sling procedures are typically performed on an outpatient basis (depending on concomitant procedures performed) and prior to dismissal all patients have a post-void residual measured via ultrasound to ensure adequate bladder emptying (defined as, greater than 2/3 of bladder capacity). All patients are scheduled for postoperative follow-up office visit at 3 months including ICIQ-FLUTS score, uroflow with ultrasound post void residual and urinalysis. Additionally, all 33 patients had been contacted with periodic follow-up mailing (at least 1 year after surgery), including ICIQ-FLUTS score. A second mailing was carried out at 1 month for initial nonresponders. The ICIQ-FLUTS is a validated questionnaire for evaluating symptoms and quality of life impact of urinary incontinence in women.18 Perioperative complications were evaluated using the Clavien-Dindo classification.19
Statistical Analysis
Comparisons of preoperative versus postoperative outcomes were performed via matchpaired analysis using a Wilcoxon signed rank test for each ICIQ-FLUTS subscore. KaplanMeier analysis was performed to evaluate recurrence free-survival, as estimated from time from sling placement to repeat surgery. Statistical analyses were performed using the JMP Pro 11 software package (SAS Institute, Cary, NC). All statistical tests were two-sided, with a p-value <0.05 considered statistically significant.
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Results
During the timeframe of the study, 33 patients underwent ATO sling placement for SUI. The median patient age was 62 years old (IQR 47.5; 70.5) with a median body mass index of 28.6 kg/m2 (IQR 24.7 kg/m2; 32.4 kg/m2). Clinical features of the entire cohort are demonstrated in Table 1. Notably, all cases were performed for symptomatic stress urinary incontinence, as verified on office cough stress test. Isolated sling placement was performed in 17 cases, of which 15 (89%) were performed on an outpatient basis. Concomitant procedures (n=16) included robotic sacrocolpopexy (n=2), anterior and/or posterior colporrhaphy (n=11), urethrovaginal fistula repair (n=2) and laparoscopic tubal ligation (n=1). The median operative time for ATO sling placement, among the 17 isolated sling cases, was 56.5 minutes (IQR 45.3, 62.3). There were no intra-operative complications.
The median follow-up was 14.9 months (IQR 3.6, 18.7), during which time five patients underwent repeat anti-incontinence surgery. Thus, 84.8% of patients (28/33) were free from retreatment at last follow-up. For those without retreatment, 25/28 (89%) completed ICIQFLUTS at last follow-up, including 18/28 (64%) completing mailed questionnaires at least oneyear after surgery. In terms of retreatment, two patients were treated with urethral bulking agent injection, and three via repeat sling placement. Two patients underwent retreatment within the first 6 months postoperatively, whereas three patients underwent retreatment more than 1 year following the initial surgery (at 12 mo, 15mo and 16 mo). In the three cases of repeat sling placement, the initial ATO sling was in the appropriate anatomic position, but was not providing adequate urethral coaptation. Hence, failure was thought to be secondary to sling tensioning or failure to have an adequate (~1cm) bridge between the two ipsilateral trocar passes.
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For those with an available ICIQ-FLUTS score at least one-year after surgery (N=18), there was significant improvement in all symptom and bother scores from baseline preoperative levels, including: the frequency (p=0.007), voiding (p=0.02) and incontinence (p=0.004) subscores, and significant improvements in quality of life related to frequency (p=0.008), voiding (p=0.002) and incontinence (p=0.01). The median time to ICIQ-FLUTS among these patients was 17.5 mo (IQR 14.8, 20.3). Notably, for those who completed questionnaires at both 3-months and at least one year after surgery (N=17), there was no significant deterioration in any ICIQ-FLUTS subscores between the 3-month and later time point. Complete details of the preoperative, 3-month and at least 1-year ICIQ-FLUTS scores are shown in Table 2. On KaplanMeier analysis, the retreatment–free survival rate was 97% at 6 months, 92% at 1 year and 75% at 18 months. (Fig 2)
With regard to complications from ATO sling placement, three patients (9%) had postoperative urinary retention, requiring temporary catheterization (all <1 week). Notably, no patients required sling release for postoperative voiding dysfunction. Additionally, three patients (9%) had abdominal wound complications, including one abdominal wall seroma managed with beside incision and drainage, one case of cellulitis managed with oral antibiotics, and an abdominal wall hematoma which was managed conservatively. No patients had persistent groin pain. Likewise, no patients suffered severe (Clavien III-V) postoperative complications.
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Discussion
In an evaluation of thirty-three consecutive women with a median 14-month follow-up, we found that autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in the majority of cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release and there were no major (Clavien III-V) complications. This report augments our initial series that suggested the technical feasibility of this procedure17 by evaluating short-term outcomes.
Prior to the development of synthetic mid-urethral slings, the autologous pubovaginal sling was the mainstay of surgical SUI therapy. Notably, the autologous pubovaginal sling has been demonstrated to have long-term efficacy.13, 14, 20 The ATO approach is an attempt to avoid the unique risks and concerns of synthetic mesh placement and minimize the morbidity encountered with pubovaginal sling placement, while maintaining high treatment success rates. The results seen here are encouraging, with significant improvement in all ICIQ-FLUTS subscores and quality of life outcomes when compared among patients with questionnaires completed at least 1-year after surgery and pre-operatively. Notably, this includes specific evaluation of both urinary incontinence and urgency domains. Importantly, the patient’s symptomatic improvement was durable, as there was no significant degradation in ICIQ-FLUTS scores between questionnaire responses over time. Likewise, the one-year retreatment-free survival rate was 92% on Kaplan-Meier analysis. Notably, the lower 18-month retreatment-free survival (75%) is in part secondary to the lower number of patients with follow-up at this time point.
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One of the most common sources of morbidity with pubovaginal sling placement is postoperative voiding dysfunction. In fact, a recent meta-analysis noted 7.5% of pubovaginal sling patients as having urinary retention greater than 6-weeks and 3% undergoing sling release for obstruction.14 By comparison, we found that with a transobturator approach to autologous sling placement, post-operative voiding dysfunction was rare and transient (less than 1 week) when encountered. Notably, no patients required sling release for obstructive voiding symptoms. Likewise, the procedures differ in that the majority of isolated sling placements in our series were performed on an outpatient basis.
Of note, both the ATO sling and pubovaginal sling placement utilize harvesting autologous tissue for the sling material and thus may have added morbidity compared to synthetic or biologic graft materials, which do not require tissue harvest. In our series three patients had abdominal wall complications, including a seroma that was drained at the bedside and a superficial wound infection necessitating oral antibiotics. This rate of complications is similar to those previously reported for pubovaginal sling placement.14 Notably, in an attempt to avoid abdominal fascial harvest and depending on surgical preference, autologous fascia lata could be used as the sling material.17, 21, 22
Limitations of our series, including its retrospective nature, are worth noting. First, we did not have complete and standardized follow-up available for all patients which may influence our results. Notably, 89% of patients had completed an ICIQ-FLUTS score at last follow-up, and 64% of patients responded to the mailed questionnaire at 1 year or greater following surgery. Furthermore, it is important to note that as our experience with this procedure has grown we have had improved outcomes, in fact two of the five surgical failures occurred within the initial
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five cases, and this may represent a portion of the learning curve, rather than a reflection on the procedure itself. Additionally, while the reported results are encouraging, they represent shortterm success and longer follow-up and comparative studies are needed. Likewise, the results represent a single surgeon series, with the procedures performed by a Urologist certified in Female Pelvic Medicine and Reconstructive Surgery. As such, these results require external validation.
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Conclusions Given the unique complications associated with synthetic mesh use and the increasing mesh aversion in patients presenting for surgical SUI management, there has been increased interest in non-mesh alternatives. In an effort to avoid mesh use and mitigate some of the known shortcomings and complications of current alternatives, we evaluated our experience with ATO sling placement. In our cohort of women undergoing autologous transobturator urethral sling placement, with a median 14-month follow-up, the technique appears a safe and feasible outpatient surgery with promising short-term outcomes. Longer follow-up and external validation are needed.
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References 1. 2. 3.
4.
5.
6. 7. 8. 9. 10. 11. 12. 13. 14.
15.
16. 17. 18.
19. 20.
Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003;189:1275-1282. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123:1201-1206. Rogo-Gupta L, Litwin MS, Saigal CS, Anger JT, Urologic Diseases in America P. Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002-2007. Urology. 2013;82:38-41. Chughtai BI, Elterman DS, Vertosick E, Maschino A, Eastham JA, Sandhu JS. Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying American Urologists. Urology. 2013;82:1267-1271. Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol. 2011;205:230 e231-235. Winters J, Rovner E, Lemack G. AUGS-SUFU Position Statement on Mesh Midurethral Slings for SUI. 2014. Dmochowski RR, Blaivas JM, Gormley EA, et al. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol. 2010;183:1906-1914. Administration USFaD. Considerations about Surgical Mesh for SUI. 3/27/2013. Perkins CE, Warrior K, Eilber KS, McClelland L, Anger JT. The Role of Mid-urethral Slings in 2014: Analysis of the Impact of Litigation on Practice. Curr Bladder Dysfunct Rep. 2015;10:39-45. Chapple CR, Raz S, Brubaker L, Zimmern PE. Mesh sling in an era of uncertainty: lessons learned and the way forward. Eur Urol. 2013;64:525-529. Brown LK, Fenner DE, Berger MB, et al. Defining patients' knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013;19:282-287. Tenggardjaja CF, Moore CK, Vasavada SP, Li J, Goldman HB. Evaluation of patients' perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology. 2015;85:326-331. Morgan TO, Jr., Westney OL, McGuire EJ. Pubovaginal sling: 4-YEAR outcome analysis and quality of life assessment. J Urol. 2000;163:1845-1848. Schimpf MO, Rahn DD, Wheeler TL, et al. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. American journal of obstetrics and gynecology. 2014;211:71 e71-71 e27. Seklehner S, Laudano MA, Xie D, Chughtai B, Lee RK. A meta-analysis of the performance of retropubic mid urethral slings versus transobturator mid urethral slings. J Urol. 2015;193:909915. Linder BJ, Elliott DS. Autologous transobturator midurethral sling placement: a novel outpatient procedure for female stress urinary incontinence. Int Urogynecol J. 2014;25:1277-1278. Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015;193:991-996. Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol. 2004;191:73-82. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187-196. Lee D, Murray S, Bacsu CD, Zimmern PE. Long-term outcomes of autologous pubovaginal fascia slings: is there a difference between primary and secondary slings? Neurourology and urodynamics. 2015;34:18-23.
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21. 22.
Govier FE, Gibbons RP, Correa RJ, Weissman RM, Pritchett TR, Hefty TR. Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency. J Urol. 1997;157:117-121. Beck RP, McCormick S, Nordstrom L. The fascia lata sling procedure for treating recurrent genuine stress incontinence of urine. Obstet Gynecol. 1988;72:699-703.
Figure Legend Figure 1- Illustration of surgical technique for autologous transobturator sling placement (Reprinted with permission from Elsevier Inc.) Figure 2- Retreatment-free survival following autologous transobturator urethral sling placement
Table 1: Clinical and demographic features for patients undergoing autologous transobturator sling placement
ATO Patients (n=33) Age, years, median (IQR) Body mass index, kg/m2, median (IQR)
62 (47.5; 70.5) 28.6 (24.7, 32.4)
Hypertension
9 (27%)
Tobacco use (current or previous)
2 (6%)
Prior anti-incontinence surgery Pre-operative 24-hour pad weight, g, median (IQR)
5 (15%) 68 (45,142.3)
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Table 2. Clinical outcomes of autologous transobturator sling placement
ICIQ-FLUTS Median (IQR) Frequency Subscore Voiding Subscore Incontinence Subscore Frequency Subscore, QoL Voiding Subscore, QoL Incontinence Subscore, QoL
Pre-op N=31
3 mo N=27
> 1 year after surgery N= 18
Preop vs >1 year p value N=18
3 mo vs >1 year p value N=17
6 (4,8)
3 (2,4)
4 (3,5)
0.007
0.53
3 (1,4)
1 (1,3)
2 (0.8,3)
0.02
0.42
11 (9,15)
4 (2,8)
4.5 (1.8,10.8)
0.004
0.21
17 (10,27)
5 (1,8)
7.5 (3.8,13.5)
0.008
0.16
8 (1,16)
1 (0,4)
2.5 (0,6.3)
0.002
0.11
34 (25.3,46.3)
6 (0,22)
11.5 (0,38.8)
0.01
0.24
QoL= Quality of Life
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S0090-4295(16)30004-8 http://dx.doi.org/doi: 10.1016/j.urology.2016.03.025 URL 19704
To appear in:
Urology
Received date: Accepted date:
12-2-2016 17-3-2016
Please cite this article as: Brian J. Linder, Daniel S. Elliott, Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term outcomes, Urology (2016), http://dx.doi.org/doi: 10.1016/j.urology.2016.03.025. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term outcomes Brian J. Linder MD and Daniel S. Elliott MD
From the Department of Urology Section of Pelvic and Reconstructive Urology Mayo Clinic, Rochester, MN Running Title: Autologous transobturator sling outcomes Key Words: autologous, transobturator, urethral sling, female stress incontinence Abstract Word Count: 250 Manuscript Word Count: 2039 Number of Tables: 2 Number of Figure: 2
Disclosures and Conflict of interest: Brian Linder- None, Daniel Elliott- None Funding: None
Corresponding author: S. Elliott, MD 284-3983 Street SW MN 55905 [email protected]
Daniel Phone: 507200 First Rochester, Email:
1
Page 1 of 15
Acknowledgements The authors would like to acknowledge the Mayo Clinic Department of Biomedical Statistics and Informatics for their assistance with the analyses in this study.
Abstract Objective: To evaluate short-term outcomes of autologous transobturator (ATO) urethral sling placement using rectus fascia for female stress urinary incontinence. Methods: We evaluated the outcomes of 33 consecutive females that underwent ATO sling placement with rectus fascia for stress incontinence from 2013-2014. Patients were seen at 3 months postoperatively and mailed a questionnaire at least one year after surgery for further follow-up. Outcomes were measured by ICIQ-FLUTS and compared between pre and postoperative responses using Wilcoxon Signed Rank test. Retreatment-free survival rates were evaluated via Kaplan-Meier method. Results: Median patient age was 62 years old (IQR 47.5;70.5) with a median BMI of 28.6 kg/m2 (IQR 24.7kg/m2; 32.4kg/m2). When isolated sling placement was performed, 88% (15/17) were outpatient procedures. Median follow-up was 14.9 months (IQR 3.6,18.7), during which five patients underwent repeat anti-incontinence surgery. For those without retreatment, 25/28 (89%) completed ICIQ-FLUTS at last follow-up. Compared to preoperative scores, patients who completed ICIQ-FLUTS questionnaires at 1-year or greater (N=18) showed significant improvement in all domains: frequency (p=0.007), voiding (p=0.02) and incontinence (p=0.004), and in quality of life related to frequency (p=0.008), voiding (p=0.002) and incontinence (p=0.01). Among those who completed questionnaires both at 3-month and at least 1 year after surgery (N=17), there was no significant deterioration in ICIQ-FLUTS scores. Overall
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Page 2 of 15
retreatment–free survival rate was 92% at 1 year. Notably, no patients suffered severe (Clavien III-V) complications or required sling release. Conclusions: Autologous transobturator urethral sling placement appears safe, with promising short-term outcomes. Longer follow-up and external validation are needed.
Introduction Stress urinary incontinence (SUI) is a highly prevalent issue in adult women, and can have a large impact on quality of life.1 In fact, it was recently estimated that the lifetime risk of a woman undergoing surgery for SUI is as high as 13.6%.2 In contemporary samples, the most common surgery performed in the management of female SUI is the midurethral synthetic sling, given its efficacy and reduced perioperative morbidity, which allows it to be performed on an outpatient basis. 3, 4 Notably, as the population in the United States ages, it is estimated that the number of SUI procedures will substantially increase, by nearly 50% by 2050 in one report.5 While multiple reports describe that synthetic mid-urethral slings are safe, effective and supported by the combined SUFU/AUGS position statement and AUA guideline,6-8 many patients and providers remain in search of non-mesh alternatives in SUI surgery.9, 10 In fact, secondary to the initial Food and Drug Administration notification on mesh use in pelvic surgery, subsequent television litigation advertisements and information encountered on the internet, many patients presenting to Female Pelvic Medicine and Reconstructive Surgery clinics have a significant aversion to the use of mesh materials.11, 12 While several options outside of synthetic midurethal sling placement exist, such as the autologous pubovaginal sling, biologic
3
Page 3 of 15
grafts, or urethral bulking agent injection, each has its own limitations, whether related to morbidity or efficacy. While the autologous pubovaginal urethral sling offers an option for management of SUI outside of synthetic mesh placement, it is associated with a higher risk of postoperative voiding dysfunction.13, 14 Notably, with synthetic sling placement, the retropubic approach has also been associated with a higher rate of post-operative voiding dysfunction when compared to the transobturator approach. 14, 15 In an attempt to avoid the unique risks of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement, all while maintaining successful surgical outcomes, we proposed the feasibility of an autologous transobturator (ATO) urethral sling.16 Here, we evaluated the short-term outcomes of patients undergoing autologous transobturator urethral sling placement.
4
Page 4 of 15
Materials and Methods
Following Institutional Review Board approval we retrospectively evaluated the outcomes of 33 consecutive female patients that underwent ATO mid-urethral sling placement for the management of bothersome symptomatic SUI from 2013 to 2014. All patients were evaluated pre-operatively with a history and physical exam, urinalysis, urine culture, 24-hour pad weight, post-void residual measured by ultrasound and International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms score (ICIQ-FLUTS). Following discussion of the AUA guideline statements and available management options for female SUI 7 all patients wished to proceed with a transobturator approach to autologous midurethral sling placement. All procedures were performed by a single surgeon (DSE).
Our initial presentation of the surgical technique for ATO sling placement, including descriptive surgical video, have been reported.16, 17 Briefly, we perform an anterior wall vaginal dissection based on the mid-urethra, similar to that utilized with the synthetic transobturator procedure, with dissection carried laterally on each side to the obturator foramen. After evaluating the distance between the obturator foramen, an abdominal anterior rectus fascial sling harvest is performed to obtain a ~1 cm x ~5 cm segment of fascia. Two stay sutures are secured to corner of the fascial segment on each side. Next, two separate trocar passages are performed on each side, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. For this, we prefer to use a reusable C-shaped trocar that was designed at our institution. Following this, the stay sutures are tied external to the obturator membrane, leaving the sling secured and flush with the urethra. Sutures are also
5
Page 5 of 15
placed to secure the sling to the periurethral tissue to prevent rolling or migration. A representative illustration of these steps is shown in Fig 1.
The ATO sling procedures are typically performed on an outpatient basis (depending on concomitant procedures performed) and prior to dismissal all patients have a post-void residual measured via ultrasound to ensure adequate bladder emptying (defined as, greater than 2/3 of bladder capacity). All patients are scheduled for postoperative follow-up office visit at 3 months including ICIQ-FLUTS score, uroflow with ultrasound post void residual and urinalysis. Additionally, all 33 patients had been contacted with periodic follow-up mailing (at least 1 year after surgery), including ICIQ-FLUTS score. A second mailing was carried out at 1 month for initial nonresponders. The ICIQ-FLUTS is a validated questionnaire for evaluating symptoms and quality of life impact of urinary incontinence in women.18 Perioperative complications were evaluated using the Clavien-Dindo classification.19
Statistical Analysis
Comparisons of preoperative versus postoperative outcomes were performed via matchpaired analysis using a Wilcoxon signed rank test for each ICIQ-FLUTS subscore. KaplanMeier analysis was performed to evaluate recurrence free-survival, as estimated from time from sling placement to repeat surgery. Statistical analyses were performed using the JMP Pro 11 software package (SAS Institute, Cary, NC). All statistical tests were two-sided, with a p-value <0.05 considered statistically significant.
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Results
During the timeframe of the study, 33 patients underwent ATO sling placement for SUI. The median patient age was 62 years old (IQR 47.5; 70.5) with a median body mass index of 28.6 kg/m2 (IQR 24.7 kg/m2; 32.4 kg/m2). Clinical features of the entire cohort are demonstrated in Table 1. Notably, all cases were performed for symptomatic stress urinary incontinence, as verified on office cough stress test. Isolated sling placement was performed in 17 cases, of which 15 (89%) were performed on an outpatient basis. Concomitant procedures (n=16) included robotic sacrocolpopexy (n=2), anterior and/or posterior colporrhaphy (n=11), urethrovaginal fistula repair (n=2) and laparoscopic tubal ligation (n=1). The median operative time for ATO sling placement, among the 17 isolated sling cases, was 56.5 minutes (IQR 45.3, 62.3). There were no intra-operative complications.
The median follow-up was 14.9 months (IQR 3.6, 18.7), during which time five patients underwent repeat anti-incontinence surgery. Thus, 84.8% of patients (28/33) were free from retreatment at last follow-up. For those without retreatment, 25/28 (89%) completed ICIQFLUTS at last follow-up, including 18/28 (64%) completing mailed questionnaires at least oneyear after surgery. In terms of retreatment, two patients were treated with urethral bulking agent injection, and three via repeat sling placement. Two patients underwent retreatment within the first 6 months postoperatively, whereas three patients underwent retreatment more than 1 year following the initial surgery (at 12 mo, 15mo and 16 mo). In the three cases of repeat sling placement, the initial ATO sling was in the appropriate anatomic position, but was not providing adequate urethral coaptation. Hence, failure was thought to be secondary to sling tensioning or failure to have an adequate (~1cm) bridge between the two ipsilateral trocar passes.
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For those with an available ICIQ-FLUTS score at least one-year after surgery (N=18), there was significant improvement in all symptom and bother scores from baseline preoperative levels, including: the frequency (p=0.007), voiding (p=0.02) and incontinence (p=0.004) subscores, and significant improvements in quality of life related to frequency (p=0.008), voiding (p=0.002) and incontinence (p=0.01). The median time to ICIQ-FLUTS among these patients was 17.5 mo (IQR 14.8, 20.3). Notably, for those who completed questionnaires at both 3-months and at least one year after surgery (N=17), there was no significant deterioration in any ICIQ-FLUTS subscores between the 3-month and later time point. Complete details of the preoperative, 3-month and at least 1-year ICIQ-FLUTS scores are shown in Table 2. On KaplanMeier analysis, the retreatment–free survival rate was 97% at 6 months, 92% at 1 year and 75% at 18 months. (Fig 2)
With regard to complications from ATO sling placement, three patients (9%) had postoperative urinary retention, requiring temporary catheterization (all <1 week). Notably, no patients required sling release for postoperative voiding dysfunction. Additionally, three patients (9%) had abdominal wound complications, including one abdominal wall seroma managed with beside incision and drainage, one case of cellulitis managed with oral antibiotics, and an abdominal wall hematoma which was managed conservatively. No patients had persistent groin pain. Likewise, no patients suffered severe (Clavien III-V) postoperative complications.
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Discussion
In an evaluation of thirty-three consecutive women with a median 14-month follow-up, we found that autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in the majority of cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release and there were no major (Clavien III-V) complications. This report augments our initial series that suggested the technical feasibility of this procedure17 by evaluating short-term outcomes.
Prior to the development of synthetic mid-urethral slings, the autologous pubovaginal sling was the mainstay of surgical SUI therapy. Notably, the autologous pubovaginal sling has been demonstrated to have long-term efficacy.13, 14, 20 The ATO approach is an attempt to avoid the unique risks and concerns of synthetic mesh placement and minimize the morbidity encountered with pubovaginal sling placement, while maintaining high treatment success rates. The results seen here are encouraging, with significant improvement in all ICIQ-FLUTS subscores and quality of life outcomes when compared among patients with questionnaires completed at least 1-year after surgery and pre-operatively. Notably, this includes specific evaluation of both urinary incontinence and urgency domains. Importantly, the patient’s symptomatic improvement was durable, as there was no significant degradation in ICIQ-FLUTS scores between questionnaire responses over time. Likewise, the one-year retreatment-free survival rate was 92% on Kaplan-Meier analysis. Notably, the lower 18-month retreatment-free survival (75%) is in part secondary to the lower number of patients with follow-up at this time point.
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One of the most common sources of morbidity with pubovaginal sling placement is postoperative voiding dysfunction. In fact, a recent meta-analysis noted 7.5% of pubovaginal sling patients as having urinary retention greater than 6-weeks and 3% undergoing sling release for obstruction.14 By comparison, we found that with a transobturator approach to autologous sling placement, post-operative voiding dysfunction was rare and transient (less than 1 week) when encountered. Notably, no patients required sling release for obstructive voiding symptoms. Likewise, the procedures differ in that the majority of isolated sling placements in our series were performed on an outpatient basis.
Of note, both the ATO sling and pubovaginal sling placement utilize harvesting autologous tissue for the sling material and thus may have added morbidity compared to synthetic or biologic graft materials, which do not require tissue harvest. In our series three patients had abdominal wall complications, including a seroma that was drained at the bedside and a superficial wound infection necessitating oral antibiotics. This rate of complications is similar to those previously reported for pubovaginal sling placement.14 Notably, in an attempt to avoid abdominal fascial harvest and depending on surgical preference, autologous fascia lata could be used as the sling material.17, 21, 22
Limitations of our series, including its retrospective nature, are worth noting. First, we did not have complete and standardized follow-up available for all patients which may influence our results. Notably, 89% of patients had completed an ICIQ-FLUTS score at last follow-up, and 64% of patients responded to the mailed questionnaire at 1 year or greater following surgery. Furthermore, it is important to note that as our experience with this procedure has grown we have had improved outcomes, in fact two of the five surgical failures occurred within the initial
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five cases, and this may represent a portion of the learning curve, rather than a reflection on the procedure itself. Additionally, while the reported results are encouraging, they represent shortterm success and longer follow-up and comparative studies are needed. Likewise, the results represent a single surgeon series, with the procedures performed by a Urologist certified in Female Pelvic Medicine and Reconstructive Surgery. As such, these results require external validation.
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Conclusions Given the unique complications associated with synthetic mesh use and the increasing mesh aversion in patients presenting for surgical SUI management, there has been increased interest in non-mesh alternatives. In an effort to avoid mesh use and mitigate some of the known shortcomings and complications of current alternatives, we evaluated our experience with ATO sling placement. In our cohort of women undergoing autologous transobturator urethral sling placement, with a median 14-month follow-up, the technique appears a safe and feasible outpatient surgery with promising short-term outcomes. Longer follow-up and external validation are needed.
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References 1. 2. 3.
4.
5.
6. 7. 8. 9. 10. 11. 12. 13. 14.
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16. 17. 18.
19. 20.
Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003;189:1275-1282. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123:1201-1206. Rogo-Gupta L, Litwin MS, Saigal CS, Anger JT, Urologic Diseases in America P. Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002-2007. Urology. 2013;82:38-41. Chughtai BI, Elterman DS, Vertosick E, Maschino A, Eastham JA, Sandhu JS. Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying American Urologists. Urology. 2013;82:1267-1271. Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol. 2011;205:230 e231-235. Winters J, Rovner E, Lemack G. AUGS-SUFU Position Statement on Mesh Midurethral Slings for SUI. 2014. Dmochowski RR, Blaivas JM, Gormley EA, et al. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol. 2010;183:1906-1914. Administration USFaD. Considerations about Surgical Mesh for SUI. 3/27/2013. Perkins CE, Warrior K, Eilber KS, McClelland L, Anger JT. The Role of Mid-urethral Slings in 2014: Analysis of the Impact of Litigation on Practice. Curr Bladder Dysfunct Rep. 2015;10:39-45. Chapple CR, Raz S, Brubaker L, Zimmern PE. Mesh sling in an era of uncertainty: lessons learned and the way forward. Eur Urol. 2013;64:525-529. Brown LK, Fenner DE, Berger MB, et al. Defining patients' knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013;19:282-287. Tenggardjaja CF, Moore CK, Vasavada SP, Li J, Goldman HB. Evaluation of patients' perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology. 2015;85:326-331. Morgan TO, Jr., Westney OL, McGuire EJ. Pubovaginal sling: 4-YEAR outcome analysis and quality of life assessment. J Urol. 2000;163:1845-1848. Schimpf MO, Rahn DD, Wheeler TL, et al. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. American journal of obstetrics and gynecology. 2014;211:71 e71-71 e27. Seklehner S, Laudano MA, Xie D, Chughtai B, Lee RK. A meta-analysis of the performance of retropubic mid urethral slings versus transobturator mid urethral slings. J Urol. 2015;193:909915. Linder BJ, Elliott DS. Autologous transobturator midurethral sling placement: a novel outpatient procedure for female stress urinary incontinence. Int Urogynecol J. 2014;25:1277-1278. Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015;193:991-996. Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol. 2004;191:73-82. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187-196. Lee D, Murray S, Bacsu CD, Zimmern PE. Long-term outcomes of autologous pubovaginal fascia slings: is there a difference between primary and secondary slings? Neurourology and urodynamics. 2015;34:18-23.
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21. 22.
Govier FE, Gibbons RP, Correa RJ, Weissman RM, Pritchett TR, Hefty TR. Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency. J Urol. 1997;157:117-121. Beck RP, McCormick S, Nordstrom L. The fascia lata sling procedure for treating recurrent genuine stress incontinence of urine. Obstet Gynecol. 1988;72:699-703.
Figure Legend Figure 1- Illustration of surgical technique for autologous transobturator sling placement (Reprinted with permission from Elsevier Inc.) Figure 2- Retreatment-free survival following autologous transobturator urethral sling placement
Table 1: Clinical and demographic features for patients undergoing autologous transobturator sling placement
ATO Patients (n=33) Age, years, median (IQR) Body mass index, kg/m2, median (IQR)
62 (47.5; 70.5) 28.6 (24.7, 32.4)
Hypertension
9 (27%)
Tobacco use (current or previous)
2 (6%)
Prior anti-incontinence surgery Pre-operative 24-hour pad weight, g, median (IQR)
5 (15%) 68 (45,142.3)
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Table 2. Clinical outcomes of autologous transobturator sling placement
ICIQ-FLUTS Median (IQR) Frequency Subscore Voiding Subscore Incontinence Subscore Frequency Subscore, QoL Voiding Subscore, QoL Incontinence Subscore, QoL
Pre-op N=31
3 mo N=27
> 1 year after surgery N= 18
Preop vs >1 year p value N=18
3 mo vs >1 year p value N=17
6 (4,8)
3 (2,4)
4 (3,5)
0.007
0.53
3 (1,4)
1 (1,3)
2 (0.8,3)
0.02
0.42
11 (9,15)
4 (2,8)
4.5 (1.8,10.8)
0.004
0.21
17 (10,27)
5 (1,8)
7.5 (3.8,13.5)
0.008
0.16
8 (1,16)
1 (0,4)
2.5 (0,6.3)
0.002
0.11
34 (25.3,46.3)
6 (0,22)
11.5 (0,38.8)
0.01
0.24
QoL= Quality of Life
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