REVIEW URRENT C OPINION

Patient satisfaction following midurethral sling surgeries Pedro A. Maldonado, Benjamin K. Kogutt, and Clifford Y. Wai

Purpose of review Patient-reported outcomes and satisfaction are recognized as being equally important as traditional objective measures of success following midurethral sling (MUS) procedures. The objective of this article is to review the success after MUSs in the context of patient satisfaction. Recent findings Patient satisfaction for both transobturator and retropubic MUSs at 2 years is high with rates up to 88%. Factors that positively influence satisfaction include improvement in quality of life and reduction in severity of symptoms. Satisfaction has been found to be negatively impacted by persistent stress incontinence, preoperative urinary urgency, mixed urinary incontinence, detrusor overactivity, and selected comorbidities such as diabetes. Factors, such as postoperative incomplete bladder emptying, irritative voiding, and complications after MUS surgery, can also influence satisfaction adversely. Summary Combining patient-reported outcome measures with customary objective measures offer a more comprehensive assessment of success. Even though the data are limited, the short-term and intermediateterm rates of satisfaction are promising for both transobturator and retropubic MUSs. Future studies should focus on further elucidating long-term predictors of satisfaction after MUS placement. Keywords midurethral slings, patient-reported outcomes, patient satisfaction

INTRODUCTION Since the introduction of the tension-free vaginal tape in 1996 [1], midurethral slings (MUSs) have become increasingly common, effectively replacing the Burch retropubic urethropexy as the ‘gold standard’ for the treatment of stress urinary incontinence. After the inception of retropubic midurethral slings (RMUSs), other slings, namely the transobturator midurethral slings (TMUSs), have evolved with the intent of reducing bladder and vascular injury by trying to avoid traversing the retropubic space. Subsequent variations of the transobturator route involved varying the introduction of the trocar from an in-to-out to an out-to-in direction. The in-to-out approach offered the potential benefit of further reducing risk of bladder injury with the trade-off of increased risk of injury to the obturator neurovascular bundle, whereas the out-to-in approach avoided a trajectory toward the obturator neurovascular bundle [2]. Patient-reported outcomes and subjective assessment are recognized as being equally important as traditional objective measures of success following MUS. Investigators have previously reported www.co-obgyn.com

on patient satisfaction following other anti-incontinence procedures. Burgio et al. [3] reported on patient satisfaction at 24 months in 480 women randomized to either Burch versus autologous fascial sling in the Stress Incontinence Surgical Treatment Efficacy Trial [3]. Using the Patient Satisfaction Questionnaire and a multivariable model, the authors determined that greater reduction in symptom distress and stress incontinence symptoms resulted in greater patient satisfaction. Additionally, greater urge incontinence symptoms at baseline appeared to be more likely associated with poor satisfaction postoperatively. Patient satisfaction after MUS placement has also been studied. In a secondary analysis of the Trial of Midurethral Slings (TOMUS), an National Institutes Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas, USA Correspondence to Clifford Y. Wai, 5323 Harry Hines Boulevard, G6.220, Dallas, TX 75390-9032, USA. Tel: +1 214 648 6430; fax: +214 648 0328; e-mail: [email protected] Curr Opin Obstet Gynecol 2014, 26:404–408 DOI:10.1097/GCO.0000000000000097 Volume 26  Number 5  October 2014

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Satisfaction after midurethral slings Maldonado et al.

KEY POINTS  High rates of satisfaction result after either retropubic or transobturator MUS placement.  Patient-reported outcomes and satisfaction are as important as objective measures of success following MUS procedures.  Lack of stress incontinence symptom improvement and increased baseline urinary symptoms may adversely affect patient satisfaction.  Preoperative mixed urinary incontinence may result in decreased postoperative patient satisfaction.

of Health sponsored Urinary Incontinence Treatment Network study satisfaction was assessed 1 year after MUS [4 ]. Baseline subjective symptom severity did not appear to differ significantly among patients who expressed satisfaction or dissatisfaction following MUS. The authors also noted that satisfaction was linked with global treatment success, baseline symptom distress, and less complications. Importantly, neither patient expectations nor preoperative perception of symptom severity appeared to affect satisfaction. The interest in characterizing subjective success has developed concurrently with the increasing number of validated questionnaires and subjective assessment tools that help identify elements contributing to patient satisfaction. Understanding these factors is essential to further characterizing success, standardizing the definitions for surgical outcomes, and improving preoperative patient counseling. The objective of this article is to review the success after MUS procedures in the context of patient satisfaction. &&

RATES OF OBJECTIVE CURE The objective efficacy of MUS procedures in the treatment of stress urinary incontinence has been established. Typical measures of objective success include a negative cough stress test, a negative 24-h pad test, or the lack of retreatment. Long-term objective success for RMUS, specifically tension-free vaginal tape, after 10–111/2 years has been reported as high as 84–90% [5–7]. Data for TMUS after 4 to 5 years following an in-out approach showed success between 74 and 82% [8,9]. Studies comparing RMUS and TMUS have demonstrated high objective success. Notably, the investigators of the TOMUS trial, a multicenter equivalence study of 565 women randomized to either RMUS or TMUS, noted 12-month objective success rates of 81 and 78%

respectively, satisfying predetermined criteria for equivalence [10]. Comparable objective efficacy between RMUS and TMUS procedures has been corroborated in other randomized controlled trials [11,12]. However, the criteria for ‘success’ of a surgical procedure are multidimensional, are dependent on the definition of success and what instruments are used to assess it, and encompass more than just an objective assessment of cure.

RATES OF SATISFACTION AND SUBJECTIVE CURE In studies examining outcomes following RMUS alone, rates of satisfaction and subjective success appear to vary depending on length of follow-up. Using the Incontinence Outcome Questionnaire (IOQ) as a measure of patient-reported outcomes 5 years after undergoing a RMUS, Bjelic-Radisic et al. [13] noted an 86% subjective cure and 83% satisfaction rate. The IOQ results appeared to correlate more with patient-reported cure rates than those on the basis of provider assessment. In a 10-year follow-up study of patients undergoing RMUS, subjective cure rate using the IOQ was 57% [5]. Another study examining 10-year outcomes following RMUS demonstrated a higher subjective cure rate, as measured by telephone-administered outcome questionnaires, of 65% [14]. Although there is a need for more studies with longer follow-up, the current reports with shortterm satisfaction and subjective cure after TMUS alone demonstrate promising results. Two-year follow-up of patients undergoing TMUS demonstrated a satisfaction rate of 88% [15]. Of note, the subjective cure rate (92%) determined by questionnaire was higher than the objective cure rate (80%), as measured by a negative stress test, further supporting the fact that ‘cure’ can vary depending on what criteria are being used. Intermediate-term data on patient satisfaction after MUS have also been promising. In a single institution prospective cohort study of patients who underwent out-in TMUS, subjective cure or satisfaction rate was 83% after a mean follow-up of 61/2 years [16 ]. Subjective cure or satisfaction rate ranged between 74 and 90% for patients 5 years after undergoing in-out TMUS [8,17 ]. A secondary analysis of a prospective randomized study of TMUS (out-in versus in-out) in patients with stress predominant mixed urinary incontinence demonstrated a patient-reported success rate of 75%, as measured by the Patient Global Impression of Improvement Questionnaire (PGI-I) [18]. Studies directly comparing outcomes following RMUS versus TMUS procedures have demonstrated

1040-872X ß 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins

&&

&

www.co-obgyn.com

405

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Urogynecology

comparable rates of satisfaction. In a 12-month secondary analysis of patients enrolled in the TOMUS trial, both retropubic and transobturator MUSs had high rates of satisfaction (86% for RMUS, 90% for TMUS) related to urinary incontinence symptoms [4 ]. Satisfaction rates remained high at 24 months (86% for RMUS, 88% for TMUS), with quality of life and symptom severity not significantly different between groups [19]. The authors concluded that the two were equivalent with regard to satisfaction, which remained high at 24 months [19]. Another multicenter randomized controlled trial of patients undergoing RMUS versus TMUS over 5 years demonstrated comparable satisfaction rates of 94 and 92% for RMUS and TMUS procedures, respectively [20 ]. At 12 months, satisfaction rates, utilizing validated disease-specific questionnaires as assessment tools, were 67, 62, and 61% for patients who underwent the RMUS, in-out TMUS, and out-in TMUS, respectively [6]. The authors also noted that satisfaction was comparable between the three groups. Most studies investigating satisfaction have relied on a single-item questionnaire that assesses overall impression of condition improvement, such as the PGI-I. Patient satisfaction with a surgical procedure is a complex outcome with multiple contributing components. Some have attempted to further characterize satisfaction by separating it into three different domains [3,21]. The Incontinence Surgery Satisfaction Questionnaire was developed as a self-administered instrument designed to study incontinence procedures. It assesses postoperative satisfaction by dividing nine items into three separate domains as follows: first, urinary leakage, urgency, and frequency, second, physical, social, or sexual activities limited preoperatively by urinary symptoms, and third, emotions accompanying their urinary symptoms. When this tool was used to study satisfaction after MUS placement in the TOMUS trial, there were no significant differences in the summary scores for each of the domains between the RMUS and TMUS groups [4 ]. &&

&&

&&

FACTORS ASSOCIATED WITH SATISFACTION Multiple factors have been implicated as possible predictors of patient satisfaction after MUS placement. Satisfaction understandably appears to be largely influenced by improvement in symptom profile. In the TOMUS trial, factors associated with greater patient satisfaction included lower Urogenital Distress Inventory (UDI) scores at baseline and decreases in UDI and Incontinence Impact Questionnaire (IIQ) scores postoperatively [4 ]. Quality of life and &&

406

www.co-obgyn.com

subjective symptom severity improvement (as measured by the IIQ, Incontinence Consultation on Incontinence Questionnaire, and PGI-I) also corresponded to high rates of satisfaction [19]. Conversely, lack of symptom improvement following MUS procedures or greater degree of bothersome symptoms, such as urinary urgency, mixed urinary incontinence, detrusor overactivity, postoperative incomplete bladder emptying, and irritative voiding, can adversely affect patient satisfaction. Higher preoperative Medical, Epidemiologic, and Social Aspects of Aging Questionnaire urgency scores and detrusor overactivity have been shown to correlate with less satisfaction postoperatively [4 ]. Additionally, a study assessing 5-year outcomes following in-out TMUS, preoperative detrusor overactivity, interval (1 year) overactive bladder symptoms, and stress incontinence symptoms were determined to be potential independent risk factors for long-term surgical failure [8]. It is not entirely surprising that preoperative detrusor overactivity is associated with a lesser degree of satisfaction, taking into account the available data linking preoperative urgency and mixed urinary incontinence with limited satisfaction. Heinonen et al. [16 ] showed that in patients who reported dissatisfaction following out-in TMUS, 59% (10/17 patients) had mixed urinary incontinence preoperatively. Importantly, statistically significant greater satisfaction was reported by patients with preoperative urodynamic stress incontinence compared with those with preoperative mixed incontinence (92 versus 76%, P < 0.001). Nilsson et al. [6] also demonstrated that the risk of urinary incontinence symptoms 1 year following MUS procedures increases if urgency and mixed urinary incontinence are present preoperatively. Postoperative factors, such as incomplete bladder emptying and irritative voiding, may also affect satisfaction. Groutz et al. [14] noted that compromised postoperative bladder emptying was a risk factor for long-term failure following RMUS. In addition, it appears that irritative voiding symptoms (assessed by UDI) are an important predictor of lower postoperative patient satisfaction (assessed by visual analog scale) [22]. Taken together, these results emphasize the potential effects of preoperative urinary symptoms on satisfaction following MUS procedures. As such, patients who are scheduled for surgery, who have these complaints at baseline should be comprehensively counseled regarding the possible worsening of these symptoms postoperatively, which may in turn result in negative subjective outcomes. Apart from preoperative urinary symptoms, baseline patient characteristics may contribute to &&

&&

Volume 26  Number 5  October 2014

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Satisfaction after midurethral slings Maldonado et al.

poor satisfaction after MUS. Factors found to be associated with recurrence of stress incontinence symptoms after in-out TMUS included age greater than 65, more than two prior vaginal deliveries, and menopause [17 ]. With regard to aging, it has been suggested that the likelihood of having urinary incontinence symptoms 1 year after MUS increases 19% for every increase in age of 10 years [6]. The exact reason for this correlation is not clear, but may relate to the fact that irritative voiding symptoms are sometimes associated with vaginal atrophy in postmenopausal women. Comorbidities, such as diabetes and obesity, may also influence postoperative satisfaction. Data from the TOMUS trial revealed that diabetes mellitus was also associated with lower satisfaction [4 ]. This may be explained by the accompanying polyuria in diabetic patients, which would be best addressed by tight glucose control perioperatively. The effect of elevated BMI on satisfaction is unclear. For example, although some have suggested that obesity could represent a predictor of RMUS failure [5], others found no differences in 1-year outcomes with respect to patient’s BMI [23]. To further illustrate the point regarding BMI, Heinonen et al. [16 ] in their cohort study of 191 women who underwent TMUS found that although obese patients had higher subjective UDI and IIQ scores, their satisfaction appeared no different compared with nonobese patients undergoing TMUS. Further studies would be helpful in elucidating the potential effects of these comorbidities on patient satisfaction. Patient’s perception of expected outcomes following MUS procedures may also play a role in satisfaction. Prior studies involving other antiincontinence surgeries showed that patients have high expectations related to outcomes, including anticipated suppression of their urgency and frequency symptoms [21]. Despite this finding, others have found no major differences between satisfied and unsatisfied patients in the severity of their preoperative incontinence symptoms or in their expectations for partial or complete relief of symptoms following either RMUS or TMUS procedures [4 ]. Nevertheless, it is always prudent to address patients’ notions and perceptions of potential outcomes preoperatively to convey clear and appropriate expectations. Not surprisingly, complications or adverse events following MUS, such as urinary retention, lower urinary tract injury, voiding dysfunction, groin pain, mesh erosion, or need for reoperation, can significantly affect a patient’s impression of the procedure’s success, and in turn may have an impact on their satisfaction. Fewer reported complications have been found to correlate with greater patient &

&&

&&

satisfaction (borderline significant, P ¼ 0.05) in both TMUS and RMUS [4 ]. In a retrospective cohort of 371 patients undergoing fascial sling versus MUS, reasons for dissatisfaction included worsening urgency incontinence (24%), de-novo urgency incontinence (24%), difficulty emptying (26%), need for reoperation (9%), and other complications (5%) [24]. Although the safety profile of MUS procedures has been established and careful counseling regarding potential complications is routine, these factors alone may not be sufficient to prepare patients for the influence of adverse events on satisfaction postoperatively. There are limited data to describe the effect of prior MUS on patient satisfaction. In one study, failure of prior incontinence surgery was the only independent predictor of subjective stress urinary incontinence recurrence following TMUS [17 ]. However, in another, prior incontinence surgery did not appear to negatively affect the outcome of future TMUS success [25]. Clearly, more research is needed to further examine the potential effect of prior incontinence surgeries of the subjective success of a subsequent MUS procedure. Concomitant pelvic floor surgery at the time of MUS does not appear to negatively affect patient satisfaction. A prospective cohort study of women undergoing prolapse repair with MUS reported on satisfaction rates (assessed by the dichotomous question ‘Are you satisfied with surgery?’) at a minimum of 1 year follow-up [26 ]. Results showed that 95% of the patients who reported combined cure (72%) of both prolapse and stress urinary incontinence symptoms were also satisfied. Vaginal surgery at the time of RMUS procedure does not appear to have a negative impact on outcomes [5]. In a retrospective review, patients who had undergone prolapse surgery alone showed comparable continence and satisfaction outcomes to those who had both prolapse repair and MUS [27]. Satisfaction in these settings is complex and is likely dependent on which symptom predominates. These data may be helpful for the counseling of the many patients who undergo combined procedures. &&

&

&

&&

CONCLUSION In addition to objective efficacy and success, MUSs have an excellent rate of satisfaction in the short and intermediate term after placement. There is compelling evidence that satisfaction and other patient-oriented outcomes are equally important as objective criteria of success of MUS procedures for the treatment of stress urinary incontinence. Patient satisfaction is a complex outcome with a multidimensional influence dependent on a variety

1040-872X ß 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins

www.co-obgyn.com

407

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Urogynecology

of factors, which include resolution of stress incontinence symptoms, severity of preoperative urinary symptoms, patient expectations, pre-existing comorbidities, and complications. Combining patient-reported outcomes with customary objective measures offers a more comprehensive assessment of success. Future studies should focus on further elucidating long-term predictors of satisfaction after MUS placement as well as standardizing the tools for its assessment. Acknowledgements None. Conflicts of interest There are no conflicts of interest.

REFERENCES AND RECOMMENDED READING Papers of particular interest, published within the annual period of review, have been highlighted as: & of special interest && of outstanding interest 1. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996; 7:81–85. 2. Zahn CM, Siddique S, Hernandez S, Lockrow EG. Anatomic comparison of two transobturator tape procedures. Obstet Gynecol 2007; 109:701–706. 3. Burgio KL, Brubaker L, Richter HE, et al. Patient satisfaction with stress incontinence surgery. Neurourol Urodyn 2010; 29:1403–1409. 4. Wai CY, Curto TM, Zyczynksi HM, et al. Patient satisfaction after midurethral && sling surgery for stress incontinence. Obstet Gynecol 2013; 121:1009– 1016. One of only a few studies to provide a comprehensive evaluation of satisfaction, accounting for its variety of influencing factors. The study provides evidence on the high rate of patient satisfaction following MUS procedures. 5. Aigmueller T, Trutnovsky G, Tamussino K, et al. Ten-year follow-up after the tension-free vaginal tape procedure. Am J Obstet Gynecol 2011; 205:496.e1– 496.e5. 6. Nilsson M, Lalos O, Lindkvist H, et al. Female urinary incontinence: patientreported outcomes 1 year after midurethral sling operations. Int Urogynecol J 2012; 23:1353–1359. 7. Olsson I, Abrahamsson AK, Kroon UB. Long-term efficacy of the tension-free vaginal tape procedure for the treatment of urinary incontinence: a retrospective follow-up 11.5 years postoperatively. Int Urogynecol J 2010; 21:679–683. 8. Groutz A, Rosen G, Gold R, et al. Long-term outcome of transobturator tension-free vaginal tape: efficacy and risk factors for surgical failure. J Womens Health (Larchmt) 2011; 20:1525–1528. 9. Liapis A, Bakas P, Creatsas G. Efficacy of inside-out transobturator vaginal tape (TVTO) at 4 years follow-up. Eur J Obstet Gynecol Reprod Biol 2010; 148:199–201. 10. Richter HE, Albo ME, Zyczynski HM, et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 2010; 362:2066– 2076.

408

www.co-obgyn.com

11. Ross S, Robert M, Swaby C, et al. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol 2009; 114:1287–1294. 12. Barber MD, Kleeman S, Karram MM, et al. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol 2008; 111:611– 621. 13. Bjelic-Radisic V, Greimel E, Trutnovsky G, et al. Patient-reported outcomes and urinary continence five years after the tension-free vaginal tape operation. Neurourol Urodyn 2011; 30:1512–1517. 14. Groutz A, Rosen G, Cohen A, et al. Ten-year subjective outcome results of the retropubic tension-free vaginal tape for treatment of stress urinary incontinence. J Minim Invasive Gynecol 2011; 18:726–729. 15. Giberti C, Gallo F, Cortese P, Schenone M. Transobturator tape for treatment of female stress urinary incontinence: objective and subjective results after a mean follow-up of two years. Urology 2007; 69:703–707. 16. Heinonen P, Ala-Nissila S, Raty R, et al. Objective cure rates and patient && satisfaction after the transobturator tape procedure during 6.5-year follow-up. J Minim Invasive Gynecol 2013; 20:73–78. This study presents long-term data that satisfaction remains high following transobturator slings. The authors advise caution in using transobturator slings in patients with mixed urinary incontinence and obesity. 17. Serati M, Bauer R, Cornu JN, et al. TVT-O for the treatment of pure urodynamic & stress incontinence: efficacy, adverse effects, and prognostic factors at 5-year follow-up. Eur Urol 2013; 63:872–878. This study provides long-term data demonstrating high satisfaction rates following in-out TMUS. Failure of prior incontinence surgery was the only independent predictor of subjective stress incontinence recurrence. 18. Abdel-fattah M, Mostafa A, Young D, Ramsay I. Evaluation of transobturator tension-free vaginal tapes in the management of women with mixed urinary incontinence: one-year outcomes. Am J Obstet Gynecol 2011; 205:150.e1– 150.e6. 19. Albo ME, Litman HJ, Richter HE, et al. Treatment success of retropubic and transobturator mid urethral slings at 24 months. J Urol 2012; 188:2281– 2287. 20. Laurikainen E, Valpas A, Aukee P, et al. Five-year results of a randomized trial && comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol 2014; 65:1109–1114. This study was a large multicenter trial comparing RMUS and TMUS at a follow-up of 5 years. Importantly, findings demonstrated high satisfaction rates after both procedures at this long-term follow-up. 21. Mallett VT, Brubaker L, Stoddard AM, et al. The expectations of patients who undergo surgery for stress incontinence. Am J Obstet Gynecol 2008; 198:308.e1–308.e6. 22. But I, Pakiz M. Irritative symptoms are the main predictor of satisfaction rate in women after transobturator tape procedures. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20:791–796. 23. Killingsworth LB, Wheeler TL 2nd, Burgio KL, et al. One-year outcomes of tension-free vaginal tape (TVT) mid-urethral slings in overweight and obese women. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20:1103– 1108. 24. Trabuco EC, Klingele CJ, Weaver AL, et al. Preoperative and postoperative predictors of satisfaction after surgical treatment of stress urinary incontinence. Am J Obstet Gynecol 2011; 204:444.e1–444.e6. 25. Biggs GY, Ballert KN, Rosenblum N, Nitti V. Patient-reported outcomes for tension-free vaginal tape-obturator in women treated with a previous antiincontinence procedure. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20:331–335. 26. Wolters JP, King AB, Rapp DE. Satisfaction in patients undergoing con& current pelvic floor surgery for stress incontinence and pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2014; 20:23–26. This study provides important insight into the impact of pelvic surgery at the time of midurethral sling surgery. 27. Chermansky CJ, Krlin RM, Winters JC. Selective management of the urethra at time of organ prolapse repair: an assessment of postoperative incontinence and patient satisfaction. J Urol 2012; 187:2144–2148.

Volume 26  Number 5  October 2014

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Patient satisfaction following midurethral sling surgeries.

Patient-reported outcomes and satisfaction are recognized as being equally important as traditional objective measures of success following midurethra...
194KB Sizes 1 Downloads 3 Views