European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 68–71
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Evaluating the results of stress urinary incontinence surgery with objective and subjective outcome measures ˜ a-Pons b On behalf of Grupo de Investigacio´n de Disfunciones de I. Diez-Itza a,*, M. Espun Suelo Pe´lvico en la Mujer– GISPEM a b
Department of Obstetrics and Gynaecology, Donostia Hospital, San Sebastia´n, Guipu´zcoa, Spain Clinical Institute of Gynaecology, Obstetrics and Neonatology, Hospital Clinic I Provincial, Barcelona, Spain
A R T I C L E I N F O
A B S T R A C T
Article history: Received 29 January 2014 Received in revised form 13 April 2014 Accepted 19 June 2014
Objective: To assess the outcomes of stress urinary incontinence (SUI) surgery using objective and subjective measures in women with pure SUI and mixed urinary incontinence (MUI). The degree of correlation between the different outcome measures was also evaluated for both groups. Study design: A multicentre prospective cohort study of women who underwent surgery for SUI. A standardized cough stress test was used as the objective outcome measure, and specific items of the Epidemiology of Prolapse and Incontinence Questionnaire were used as the subjective outcome measure. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Patient Global Impression of Improvement (PGI-I) questionnaires were used for global assessment. Kappa test was used to measure the degree of correlation between the outcome measures. Results: The participants were categorized into two groups before surgery: pure SUI (n = 116) and MUI (n = 161). Six months after surgery, the cure rate of the SUI component was high in both groups according to the objective and subjective outcome measures. Global assessment showed lower cure rates. The degree of agreement between objective and subjective outcome measures was moderate (kappa 0.541, p < 0.001) for women with pure SUI, and fair (kappa 0.377, p < 0.001) for women with MUI. Correlation between the change in ICIQ-UI SF score (pre to post surgery) and the degree of satisfaction (PGI-I) was significant (p < 0.01) for both the pure SUI group (0.43) and the MUI group (0.48). Conclusions: Both objective and subjective cure rates are high for women with pure SUI and MUI following SUI surgery in Spain. The degree of agreement between different outcome measures varies. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Stress urinary incontinence Surgery Outcome measures
Introduction The assessment of outcomes following stress urinary incontinence (SUI) surgery is a controversial issue that involves various factors. There are objective and subjective outcome measures (OMs) for the definition of cure or improvement. Moreover, the fact that SUI is often accompanied by urge urinary incontinence (UUI), and the fact that the latter may appear de novo after surgery, makes it difficult to establish the terms by which the success of SUI surgery should be defined.
* Corresponding author at: Departamento de Obstetricia y Ginecologı´a, Hospital Universitario Donostia, Paseo Beguiristain, 107-115, 20014 San Sebastia´n, Guipu´zcoa, Spain. Tel.: +34 943 00 70 00. E-mail address: [email protected] (I. Diez-Itza). http://dx.doi.org/10.1016/j.ejogrb.2014.06.020 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
Objective measures evaluate signs of incontinence and include the stress test, the pad test and urodynamic study. Subjective measures assess patients’ perceptions of their symptoms and how their quality of life is affected, using self-administered questionnaires. Patients’ impressions regarding improvement of urinary incontinence (UI) is also a subjective measure for global evaluation. This aspect is very important and must be taken into account; as UI is a condition that affects quality of life, there is a need to measure patients’ perceptions of surgical outcomes [1]. The definition of cure proposed by the National Institute of Health involves resolution of incontinence symptoms, resolution of the signs of incontinence, and the absence of new symptoms or side effects [2]. This definition may be useful for ascertaining overall surgical outcomes, but some researchers believe that the stress and urge components of UI should be considered separately [3].
I. Diez-Itza, M. Espun˜a-Pons / European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 68–71
Knowledge of the correlation between different OMs may help to resolve the controversy in the assessment of results following SUI surgery. This information could be relevant not only for comparing the results of different studies, but to determine which OMs provide a better reflection of surgical results. The aim of this study was to evaluate outcomes following SUI surgery using objective and subjective measures in patients with pure SUI and mixed urinary incontinence (MUI). This study also aimed to analyze the degree of correlation between the different OMs for both groups. Materials and methods This multicentre prospective study included women diagnosed with SUI and MUI with predominance of the stress component, and undergoing SUI surgery with or without associated pelvic organ prolapse (POP) surgery. All participants were fully informed about the nature and objectives of the study before enrolment, and gave their written informed consent. The study protocol was approved by the Clinical Research Ethics Committee of Clinic i Provincial Hospital in Barcelona. Thirty-five specialized pelvic floor units that are part of the Grupo de Investigacio´n en Suelo Pe´lvico de la Mujer in Spain participated in this study. At the baseline visit, a physical examination was performed to identify SUI and POP. Signs of incontinence were evaluated with a stress test with a full bladder. Patients were asked to cough three times in a standing position. When POP was present, women were also asked to cough three times in a gynaecological position while the prolapse was reduced with a posterior valve. In addition, patients answered the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [4] and the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) [5]. Both questionnaires are selfadministered and have been validated in Spanish [6,7]. The ICIQUI SF comprised several questions, all pertaining to UI. The EPIQ is a longer questionnaire that covers the presence of various urinary symptoms and other pelvic floor dysfunctions, and the degree of bother. SUI was diagnosed when patients reported involuntary loss of urine on coughing, sneezing or exercising once a month or more, when this leak was bothersome enough to seek treatment, and when they had a positive stress test on physical examination. Urge incontinence was diagnosed when patients answered ‘yes’ to the urge incontinence item from EPIQ: ‘Do you leak urine when you have an urgent need to urinate?’ Surgical outcomes were evaluated 6 months after surgery using objective and subjective measures. Objective cure was defined as a negative stress test performed in the same conditions as at the baseline visit. At the follow-up visit, the women completed the ICIQ-UI SF and EPIQ about their urinary symptoms. They also answered a third questionnaire, the Patient’s Global Impression of Improvement (PGI-I), which compares current symptom status with the pre-treatment situation. The PGI-I has been validated for use in patients with SUI [8]. Data pertaining to the type of surgery applied for incontinence and POP, as well as intra-operative and postoperative complications, were collected from patients’ medical records. Statistical analysis Continuous variables are described using means and standard deviations (SD), and categorical variables are described using proportions. Means were compared using Student’s t-test, and proportions were compared using Chi-squared test. Correlations between the different measures were analyzed using the kappa
69
Table 1 General characteristics and types of intervention for patients with pure stress urinary incontinence (SUI) and mixed urinary incontinence (MUI). Pure SUI (n = 116)
MUI (n = 161)
p-Value
Mean (SD) Mean (SD) Mean (SD) n (%) n (%) n (%) n (%)
54.6 10.2 2.31 1.09 27.7 5.1 69 (59.4) 10 (8.6) 12 (10.3) 42 (36.2)
57.1 11.8 2.48 1.00 27.9 4.4 101 (62.7) 20 (12.4) 20 (12.4) 53 (32.9)
0.06 0.20 0.81 0.18 0.35 0.61 0.49
n n n n n
9 (7.7) 82 (70.7) 22 (19.0) 1 (0.9) 2 (1.7)
9 (5.6) 124 (77.0) 20 (11.4) 4 (2.5) 4 (2.5)
0.45 0.08 0.10 0.65 0.55
Characteristics Age (years) Vaginal births (n) Body mass index (kg/m2) Menopause Previous SUI surgery Previous hysterectomy POP surgery SUI surgery Retropubic Transobturator Mini-sling Adjustable Other
(%) (%) (%) (%) (%)
POP, pelvic organ prolapse; SD, standard deviation.
correlation test and Spearman’s correlation coefficient. p < 0.05 was considered to indicate significance. Results Three hundred and eight women undergoing SUI surgery at 35 Spanish pelvic floor units were included in this study. Of these, 277 (89.9%) women attended the follow-up visit and completed the self-administered questionnaires, and thus constituted the study group. Mean age was 56.1 (SD 11.2) years and mean body mass index was 27.8 (SD 4.7) kg/m2. Two groups were established before surgery: pure SUI (n = 116) and MUI (n = 161). Baseline characteristics and type of surgery are detailed in Table 1. No significant differences were found for any of the variables studied. The most common surgical technique in both groups was the placement of a transobturator suburethral sling. Complication rates were low and did not differ significantly between the two groups (Table 2). Evaluation of the surgical outcomes with objective and subjective measures is detailed in Table 3. The objective cure rate for the stress component was high and similar for both groups, but the subjective cure rate was somewhat lower. Sixty percent of women with MUI had their SUI symptoms cured. Eleven percent of patients with SUI presented with de novo UUI following surgery. The global evaluation of surgical outcomes using the ICIQ-UI SF and PGI-I presented substantially lower figures. Surgical outcomes were also assessed using the change in ICIQUI SF score from pre to post surgery (Table 4). As expected, most women in both groups reported an improvement after surgery. The degree of correlation between the different measures was evaluated for the stress component (stress test vs SUI symptoms) and for global outcomes (change in ICIQ-UI SF score vs PGI-I). The Table 2 Intra-operative and postoperative complications. Complications Intra-operative Haemorrhage Bladder perforation Postoperative Urinary tract infection Haematoma Urinary retention Vaginal erosion Neurological pain Pain on intercourse Micturition difficulty
n (%) n (%) n n n n n n n
(%) (%) (%) (%) (%) (%) (%)
Pure SUI (n = 116)
MUI (n = 161)
4 (3.5) 2 (1.7)
2 (1.3) 1 (0.6)
10 5 6 2 1 3 2
(8.6) (4.3) (5.2) (1.7) (0.9) (2.6) (1.7)
12 2 5 2 0 0 2
(7.5) (1.2) (3.1) (1.2) (0) (0) (1.2)
SUI, stress urinary incontinence; MUI, mixed urinary incontinence.
p-Value
0.23 0.57 0.72 0.13 0.38 1.00 0.41 0.07 1.00
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I. Diez-Itza, M. Espun˜a-Pons / European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 68–71
Table 3 Evaluation of surgical results using objective and subjective outcome measures in women with pure stress urinary incontinence (SUI) and women with mixed urinary incontinence (MUI). Subjective and objective outcome measures SUI objective cure rate SUI subjective cure rate Resolution of urge component Appearance of de novo UUI Global UI subjective cure rate ICIQ-UI SF = 0 ICIQ-UI SF < 5 Patient global impression of improvement ‘Very much better’ or ‘much better’
Pure SUI (n = 116)
MUI (n = 161)
(%) (%) (%) (%)
108 (93.1) 100 (86.2) – 13 (11.2)
146 (90.7) 140 (87.0) 98 (60.8) –
n (%) n (%)
81 (69.8) 97 (83.6)
78 (48.4) 105 (65.2)
n (%)
102 (87.9)
139 (86.3)
n n n n
UUI, urge urinary incontinence; UI, urinary incontinence; ICIQ-UI SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
Table 4 Change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score after surgery. ICIQ-UI SF score after surgery Worse Same Better
n (%) n (%) n (%)
Pure SUI (n = 116)
MUI (n = 161)
7 (6) 5 (4.3) 103 (88.8)
7 (4.3) 4 (2.5) 150 (93.2)
SUI, stress urinary incontinence; MUI, mixed urinary incontinence.
degree of correlation for cure of the stress component was significant (p < 0.001) in both groups, and is shown in Table 5. The degree of correlation between the change in ICIQ-UI SF score and the degree of satisfaction reflected in the PGI-I was also significant (p < 0.01) for both the pure SUI group (0.43) and the MUI group (0.48). Comment This study evaluated the outcomes of minimally invasive SUI surgery from different standpoints, and analyzed the correlations between them. Outcomes following minimally invasive SUI surgery have been addressed in several studies. However, few authors have included not only objective and subjective measures, but also other like the global impression of change and degree of satisfaction with treatment. A recent review [9] highlighted the wide variety of measures used to assess outcomes following SUI surgery and their lack of standardization, and reported that few authors follow the recommendations of the International Continence Society (ICS) for collecting results. In fact, of the 141 publications reviewed, only two studies followed the ICS recommendations. A Cochrane review [10] also reported that many studies on anti-incontinence surgery have not clarified the measures applied, and there is a need to include quality-of-life evaluation in surgical outcomes. It is important to approach the evaluation of outcomes following SUI surgery from different standpoints, as each standpoint will provide data that will improve knowledge of these outcomes.
In this study, the cure rate of the stress component was good for women with pure SUI and women with MUI. The stress test presented substantially higher figures compared with the disappearance of the symptom reflected in the EPIQ. Although both measures show good outcomes following anti-incontinence surgery, the limited degree of agreement between them is striking. Both groups included women who did not report stress leakage in the EPIQ although they had a positive stress test, and women who reported stress leakage in the EPIQ but did not have a positive stress test. The latter represents the main reason for lack of agreement between the two measures. This study corroborates the fact that minimally invasive SUI surgery offers very good outcomes for curing the signs and symptoms of incontinence. The objective and subjective cure rates are in agreement with the majority of published studies, with rates ranging from 80% to 95% and from 70% to 90%, respectively [10–12]. As expected, the global evaluation of surgical outcomes presented lower cure rates. Using a strict incontinence cure measure (ICIQ-UI SF = 0), rates of 70% and 48% were obtained for the pure SUI and MUI groups, respectively. Barber et al. [13] reported a subjective cure rate for stress symptoms of 85% in patients undergoing transobturator tape and tension-free vaginal tape procedures, but only 60% of patients reported that they were dry when evaluating global results with the Incontinence Severity Index. These differences were also observed with other types of SUI surgery [14–17]. The ICIQ-UI SF contains incontinence symptoms, but does not specify the type. The fact that SUI surgery may promote the appearance of de novo UUI partially explains the differences for the group with pure SUI. In the case of patients with MUI, the persistence of UUI after surgery would explain the low cure rates reflected with this questionnaire. Evaluation of the degree of satisfaction after surgery using the PGI-I showed that 88% of women with pure SUI symptoms and 86% of women with MUI symptoms were ‘very much better’ or ‘much better’ after surgery. These rates agree with data published by other authors that also include different types of anti-incontinence surgery with slings [13]. The degree of correlation between the two questionnaires that provide overall results was moderate for both the pure SUI and the MUI groups. Frick et al. [18] analyzed the degree of correlation between the PGI-I and different UI evaluation instruments, including the Pelvic Floor Distress Inventory 20 score, that do not evaluate UI symptoms exclusively. The degree of correlation, while statistically significant, was lower compared with the present study. The degree of correlation is important because patient satisfaction with surgery is a key element in evaluation [1]. Another interesting aspect of this study is the cure rate of the urge component in patients undergoing SUI surgery. Sixty-one percent of patients diagnosed with MUI reported that they did not have UUI following anti-incontinence surgery. This has also been indicated by other authors. Tahseen and Reid [19] reported an urge cure rate of 43% in patients undergoing surgery for SUI using a transobturator technique, whereas Segal et al. [20] reported an urge cure rate of 63% after a TVT-type retropubic sling was fitted.
Table 5 Degree of agreement between objective (stress test) and subjective (symptoms of stress urinary incontinence) measures for the evaluation of cure of the stress component of urinary incontinence. Group with pure SUI (n = 116)
Objective cure ‘no’ Objective cure ‘yes’
Group with MUI (n = 161)
Subjective cure ‘no’
Subjective cure ‘yes’
Subjective cure ‘no’
Subjective cure ‘yes’
7 9
1 99
8 13
7 133
kappa = 0.541 (p < 0.001) SUI, stress urinary incontinence; MUI, mixed urinary incontinence.
kappa = 0.377 (p < 0.001)
I. Diez-Itza, M. Espun˜a-Pons / European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 68–71
Several theories have been proposed to explain these results, such as the suburethral sling may stabilize the bladder neck, preventing the stretching of pelvic nerves that could be involved in triggering an involuntary detrusor contraction; and the sling may prevent the entry of urine into the proximal urethra, avoiding the sensory stimulation that could promote a reflex detrusor contraction [20]. One of the strengths of this study is its prospective, multicentre design. Thirty-five specialized pelvic floor units in Spain participated, and the three most common minimally invasive surgical techniques for incontinence were performed. This allowed the authors to ascertain the current situation in terms of antiincontinence surgical outcomes in clinical practice in Spain. Another strength of this study is the use of different measures to evaluate outcomes. By doing so, the authors sought to address the concept of cure from different perspectives, demonstrating the variability of cure rates according to the tool used for evaluation, and correlation between the measures. One of the limitations of this study is the short follow-up period for the evaluation of surgical outcomes. Moreover, some patients failed to complete the questionnaires properly. This study is also limited in terms of assessing postsurgical complications. As the complication rate was low, statistical power was insufficient to guarantee that there are no significant differences in the complication rates for the two groups. Despite these limitations, this study demonstrated that there is no single ideal measure for the evaluation of surgical outcomes in patients with pure SUI and MUI, and the degree of agreement between the different OMs varies from moderate to fair. Therefore, caution is recommended when comparing the results of studies using different OMs. One objective measure is not sufficient to detect surgical failures, and no single questionnaire provides sufficient data for subjective evaluation. For patients with pure SUI, the ICIQ-UI SF can identify cases who are totally cured, those who have improved, and those who are the same or worse, and also allows cases to be categorized (before and after surgery) depending on the severity of UI. Nevertheless, when symptoms are mixed, a combination of more than one instrument is ideal. Use of the ICIQ-UI SF, which measures surgical outcomes for UI, with a questionnaire that enables evaluation of the impact of surgery on symptoms (e.g. increased daytime urinary frequency, urgency and urge incontinence) is recommended. Acknowledgements The authors wish to thank all the GISPEM participants for their collaboration and involvement in this study. The work was funded by Astellas Pharma S.A. (Grant no. VH 1-09).
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References [1] Tincello DG, Alfirevic Z. Important clinical outcomes in urogynecology: views of patients, nurses and medical staff. Int Urogynecol J 2002;13: 96–8. [2] Weber AM, Abrams P, Brubaker L, et al. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:178–86. [3] Brubaker L, Stoddard A, Richter H, et al. Mixed incontinence: comparing definitions in women having stress incontinence surgery. Neurourol Urodyn 2009;28:268–73. [4] Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004;23:322–30. [5] Lukacz ES, Lawrence JM, Buckwalter JG, Burchette RJ, Nager CW, Luber KM. Epidemiology of prolapse and incontinence questionnaire: validation of a new epidemiologic survey. Int Urogynecol J Pelvic Floor Dysfunct 2005;16:272–84. ˜ a M, Rebollo P, Puig M. Validacio´n de la versio´n espan ˜ ola del F ICIQ-UI SF. [6] Espun Un cuestionario para evaluar la incontinencia urinaria. Med Clin (Barc) 2004;122:288–92. ˜ a M, Fillol M, Pascual MA, Rebollo P, Prieto M. Validacio´n de la versio´n en [7] Espun ˜ ol del cuestionario ‘Epidemiology of Prolapse and Incontinence Quesespan tionnaire-EPIQ’. Acta Urol Esp 2009;33:646–53. [8] Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98–101. [9] Castillo PA, Espaillat-Rijo LM, Davila GW. Outcome measures and definition of cure in female stress urinary incontinence surgery: a survey of recent publications. Int Urogynecol J 2010;21:343–8. [10] Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2009;4:CD006375. [11] Smith ARB, Dmochowski R, Hilton P, et al. Surgery for urinary incontinence in women. In: 4th International Consultation on Incontinence (ICI); 2009.p.
1193–272. [12] Latthe PM, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and metaanalysis of effectiveness and complications. BJOG 2007;114:522–31. [13] 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;111:611–21. [14] Ward KL, Hilton P. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 2004;190:324–31. [15] Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol 2004;104:1249–58. [16] Albo ME, Richter HE, Brubaker L, et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med 2007;356:2143–55. [17] Hilton P. Trials of surgery for stress incontinence – thoughts on the ‘Humpty Dumpty principle’. BJOG 2002;109:1081–8. [18] Frick AC, Ridgeway B, Ellerkmann M, et al. Comparison of responsiveness of validated outcome measures after surgery for stress urinary incontinence. J Urol 2010;184:2013–7. [19] Tahseen S, Reid P. Effect of transobturator tape on overactive bladder symptoms and urge urinary incontinence in women with mixed urinary incontinence. Obstet Gynecol 2009;113:617–23. [20] Segal JL, Vassallo B, Kleeman S, Silva A, Karram MM. Prevalence of persistent and de novo overactive bladder symptoms after the tension-free vaginal tape. Obstet Gynecol 2004;104:1263–9.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Evaluating the results of stress urinary incontinence surgery with objective and subjective outcome measures ˜ a-Pons b On behalf of Grupo de Investigacio´n de Disfunciones de I. Diez-Itza a,*, M. Espun Suelo Pe´lvico en la Mujer– GISPEM a b
Department of Obstetrics and Gynaecology, Donostia Hospital, San Sebastia´n, Guipu´zcoa, Spain Clinical Institute of Gynaecology, Obstetrics and Neonatology, Hospital Clinic I Provincial, Barcelona, Spain
A R T I C L E I N F O
A B S T R A C T
Article history: Received 29 January 2014 Received in revised form 13 April 2014 Accepted 19 June 2014
Objective: To assess the outcomes of stress urinary incontinence (SUI) surgery using objective and subjective measures in women with pure SUI and mixed urinary incontinence (MUI). The degree of correlation between the different outcome measures was also evaluated for both groups. Study design: A multicentre prospective cohort study of women who underwent surgery for SUI. A standardized cough stress test was used as the objective outcome measure, and specific items of the Epidemiology of Prolapse and Incontinence Questionnaire were used as the subjective outcome measure. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Patient Global Impression of Improvement (PGI-I) questionnaires were used for global assessment. Kappa test was used to measure the degree of correlation between the outcome measures. Results: The participants were categorized into two groups before surgery: pure SUI (n = 116) and MUI (n = 161). Six months after surgery, the cure rate of the SUI component was high in both groups according to the objective and subjective outcome measures. Global assessment showed lower cure rates. The degree of agreement between objective and subjective outcome measures was moderate (kappa 0.541, p < 0.001) for women with pure SUI, and fair (kappa 0.377, p < 0.001) for women with MUI. Correlation between the change in ICIQ-UI SF score (pre to post surgery) and the degree of satisfaction (PGI-I) was significant (p < 0.01) for both the pure SUI group (0.43) and the MUI group (0.48). Conclusions: Both objective and subjective cure rates are high for women with pure SUI and MUI following SUI surgery in Spain. The degree of agreement between different outcome measures varies. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Stress urinary incontinence Surgery Outcome measures
Introduction The assessment of outcomes following stress urinary incontinence (SUI) surgery is a controversial issue that involves various factors. There are objective and subjective outcome measures (OMs) for the definition of cure or improvement. Moreover, the fact that SUI is often accompanied by urge urinary incontinence (UUI), and the fact that the latter may appear de novo after surgery, makes it difficult to establish the terms by which the success of SUI surgery should be defined.
* Corresponding author at: Departamento de Obstetricia y Ginecologı´a, Hospital Universitario Donostia, Paseo Beguiristain, 107-115, 20014 San Sebastia´n, Guipu´zcoa, Spain. Tel.: +34 943 00 70 00. E-mail address: [email protected] (I. Diez-Itza). http://dx.doi.org/10.1016/j.ejogrb.2014.06.020 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
Objective measures evaluate signs of incontinence and include the stress test, the pad test and urodynamic study. Subjective measures assess patients’ perceptions of their symptoms and how their quality of life is affected, using self-administered questionnaires. Patients’ impressions regarding improvement of urinary incontinence (UI) is also a subjective measure for global evaluation. This aspect is very important and must be taken into account; as UI is a condition that affects quality of life, there is a need to measure patients’ perceptions of surgical outcomes [1]. The definition of cure proposed by the National Institute of Health involves resolution of incontinence symptoms, resolution of the signs of incontinence, and the absence of new symptoms or side effects [2]. This definition may be useful for ascertaining overall surgical outcomes, but some researchers believe that the stress and urge components of UI should be considered separately [3].
I. Diez-Itza, M. Espun˜a-Pons / European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 68–71
Knowledge of the correlation between different OMs may help to resolve the controversy in the assessment of results following SUI surgery. This information could be relevant not only for comparing the results of different studies, but to determine which OMs provide a better reflection of surgical results. The aim of this study was to evaluate outcomes following SUI surgery using objective and subjective measures in patients with pure SUI and mixed urinary incontinence (MUI). This study also aimed to analyze the degree of correlation between the different OMs for both groups. Materials and methods This multicentre prospective study included women diagnosed with SUI and MUI with predominance of the stress component, and undergoing SUI surgery with or without associated pelvic organ prolapse (POP) surgery. All participants were fully informed about the nature and objectives of the study before enrolment, and gave their written informed consent. The study protocol was approved by the Clinical Research Ethics Committee of Clinic i Provincial Hospital in Barcelona. Thirty-five specialized pelvic floor units that are part of the Grupo de Investigacio´n en Suelo Pe´lvico de la Mujer in Spain participated in this study. At the baseline visit, a physical examination was performed to identify SUI and POP. Signs of incontinence were evaluated with a stress test with a full bladder. Patients were asked to cough three times in a standing position. When POP was present, women were also asked to cough three times in a gynaecological position while the prolapse was reduced with a posterior valve. In addition, patients answered the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [4] and the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) [5]. Both questionnaires are selfadministered and have been validated in Spanish [6,7]. The ICIQUI SF comprised several questions, all pertaining to UI. The EPIQ is a longer questionnaire that covers the presence of various urinary symptoms and other pelvic floor dysfunctions, and the degree of bother. SUI was diagnosed when patients reported involuntary loss of urine on coughing, sneezing or exercising once a month or more, when this leak was bothersome enough to seek treatment, and when they had a positive stress test on physical examination. Urge incontinence was diagnosed when patients answered ‘yes’ to the urge incontinence item from EPIQ: ‘Do you leak urine when you have an urgent need to urinate?’ Surgical outcomes were evaluated 6 months after surgery using objective and subjective measures. Objective cure was defined as a negative stress test performed in the same conditions as at the baseline visit. At the follow-up visit, the women completed the ICIQ-UI SF and EPIQ about their urinary symptoms. They also answered a third questionnaire, the Patient’s Global Impression of Improvement (PGI-I), which compares current symptom status with the pre-treatment situation. The PGI-I has been validated for use in patients with SUI [8]. Data pertaining to the type of surgery applied for incontinence and POP, as well as intra-operative and postoperative complications, were collected from patients’ medical records. Statistical analysis Continuous variables are described using means and standard deviations (SD), and categorical variables are described using proportions. Means were compared using Student’s t-test, and proportions were compared using Chi-squared test. Correlations between the different measures were analyzed using the kappa
69
Table 1 General characteristics and types of intervention for patients with pure stress urinary incontinence (SUI) and mixed urinary incontinence (MUI). Pure SUI (n = 116)
MUI (n = 161)
p-Value
Mean (SD) Mean (SD) Mean (SD) n (%) n (%) n (%) n (%)
54.6 10.2 2.31 1.09 27.7 5.1 69 (59.4) 10 (8.6) 12 (10.3) 42 (36.2)
57.1 11.8 2.48 1.00 27.9 4.4 101 (62.7) 20 (12.4) 20 (12.4) 53 (32.9)
0.06 0.20 0.81 0.18 0.35 0.61 0.49
n n n n n
9 (7.7) 82 (70.7) 22 (19.0) 1 (0.9) 2 (1.7)
9 (5.6) 124 (77.0) 20 (11.4) 4 (2.5) 4 (2.5)
0.45 0.08 0.10 0.65 0.55
Characteristics Age (years) Vaginal births (n) Body mass index (kg/m2) Menopause Previous SUI surgery Previous hysterectomy POP surgery SUI surgery Retropubic Transobturator Mini-sling Adjustable Other
(%) (%) (%) (%) (%)
POP, pelvic organ prolapse; SD, standard deviation.
correlation test and Spearman’s correlation coefficient. p < 0.05 was considered to indicate significance. Results Three hundred and eight women undergoing SUI surgery at 35 Spanish pelvic floor units were included in this study. Of these, 277 (89.9%) women attended the follow-up visit and completed the self-administered questionnaires, and thus constituted the study group. Mean age was 56.1 (SD 11.2) years and mean body mass index was 27.8 (SD 4.7) kg/m2. Two groups were established before surgery: pure SUI (n = 116) and MUI (n = 161). Baseline characteristics and type of surgery are detailed in Table 1. No significant differences were found for any of the variables studied. The most common surgical technique in both groups was the placement of a transobturator suburethral sling. Complication rates were low and did not differ significantly between the two groups (Table 2). Evaluation of the surgical outcomes with objective and subjective measures is detailed in Table 3. The objective cure rate for the stress component was high and similar for both groups, but the subjective cure rate was somewhat lower. Sixty percent of women with MUI had their SUI symptoms cured. Eleven percent of patients with SUI presented with de novo UUI following surgery. The global evaluation of surgical outcomes using the ICIQ-UI SF and PGI-I presented substantially lower figures. Surgical outcomes were also assessed using the change in ICIQUI SF score from pre to post surgery (Table 4). As expected, most women in both groups reported an improvement after surgery. The degree of correlation between the different measures was evaluated for the stress component (stress test vs SUI symptoms) and for global outcomes (change in ICIQ-UI SF score vs PGI-I). The Table 2 Intra-operative and postoperative complications. Complications Intra-operative Haemorrhage Bladder perforation Postoperative Urinary tract infection Haematoma Urinary retention Vaginal erosion Neurological pain Pain on intercourse Micturition difficulty
n (%) n (%) n n n n n n n
(%) (%) (%) (%) (%) (%) (%)
Pure SUI (n = 116)
MUI (n = 161)
4 (3.5) 2 (1.7)
2 (1.3) 1 (0.6)
10 5 6 2 1 3 2
(8.6) (4.3) (5.2) (1.7) (0.9) (2.6) (1.7)
12 2 5 2 0 0 2
(7.5) (1.2) (3.1) (1.2) (0) (0) (1.2)
SUI, stress urinary incontinence; MUI, mixed urinary incontinence.
p-Value
0.23 0.57 0.72 0.13 0.38 1.00 0.41 0.07 1.00
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Table 3 Evaluation of surgical results using objective and subjective outcome measures in women with pure stress urinary incontinence (SUI) and women with mixed urinary incontinence (MUI). Subjective and objective outcome measures SUI objective cure rate SUI subjective cure rate Resolution of urge component Appearance of de novo UUI Global UI subjective cure rate ICIQ-UI SF = 0 ICIQ-UI SF < 5 Patient global impression of improvement ‘Very much better’ or ‘much better’
Pure SUI (n = 116)
MUI (n = 161)
(%) (%) (%) (%)
108 (93.1) 100 (86.2) – 13 (11.2)
146 (90.7) 140 (87.0) 98 (60.8) –
n (%) n (%)
81 (69.8) 97 (83.6)
78 (48.4) 105 (65.2)
n (%)
102 (87.9)
139 (86.3)
n n n n
UUI, urge urinary incontinence; UI, urinary incontinence; ICIQ-UI SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.
Table 4 Change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score after surgery. ICIQ-UI SF score after surgery Worse Same Better
n (%) n (%) n (%)
Pure SUI (n = 116)
MUI (n = 161)
7 (6) 5 (4.3) 103 (88.8)
7 (4.3) 4 (2.5) 150 (93.2)
SUI, stress urinary incontinence; MUI, mixed urinary incontinence.
degree of correlation for cure of the stress component was significant (p < 0.001) in both groups, and is shown in Table 5. The degree of correlation between the change in ICIQ-UI SF score and the degree of satisfaction reflected in the PGI-I was also significant (p < 0.01) for both the pure SUI group (0.43) and the MUI group (0.48). Comment This study evaluated the outcomes of minimally invasive SUI surgery from different standpoints, and analyzed the correlations between them. Outcomes following minimally invasive SUI surgery have been addressed in several studies. However, few authors have included not only objective and subjective measures, but also other like the global impression of change and degree of satisfaction with treatment. A recent review [9] highlighted the wide variety of measures used to assess outcomes following SUI surgery and their lack of standardization, and reported that few authors follow the recommendations of the International Continence Society (ICS) for collecting results. In fact, of the 141 publications reviewed, only two studies followed the ICS recommendations. A Cochrane review [10] also reported that many studies on anti-incontinence surgery have not clarified the measures applied, and there is a need to include quality-of-life evaluation in surgical outcomes. It is important to approach the evaluation of outcomes following SUI surgery from different standpoints, as each standpoint will provide data that will improve knowledge of these outcomes.
In this study, the cure rate of the stress component was good for women with pure SUI and women with MUI. The stress test presented substantially higher figures compared with the disappearance of the symptom reflected in the EPIQ. Although both measures show good outcomes following anti-incontinence surgery, the limited degree of agreement between them is striking. Both groups included women who did not report stress leakage in the EPIQ although they had a positive stress test, and women who reported stress leakage in the EPIQ but did not have a positive stress test. The latter represents the main reason for lack of agreement between the two measures. This study corroborates the fact that minimally invasive SUI surgery offers very good outcomes for curing the signs and symptoms of incontinence. The objective and subjective cure rates are in agreement with the majority of published studies, with rates ranging from 80% to 95% and from 70% to 90%, respectively [10–12]. As expected, the global evaluation of surgical outcomes presented lower cure rates. Using a strict incontinence cure measure (ICIQ-UI SF = 0), rates of 70% and 48% were obtained for the pure SUI and MUI groups, respectively. Barber et al. [13] reported a subjective cure rate for stress symptoms of 85% in patients undergoing transobturator tape and tension-free vaginal tape procedures, but only 60% of patients reported that they were dry when evaluating global results with the Incontinence Severity Index. These differences were also observed with other types of SUI surgery [14–17]. The ICIQ-UI SF contains incontinence symptoms, but does not specify the type. The fact that SUI surgery may promote the appearance of de novo UUI partially explains the differences for the group with pure SUI. In the case of patients with MUI, the persistence of UUI after surgery would explain the low cure rates reflected with this questionnaire. Evaluation of the degree of satisfaction after surgery using the PGI-I showed that 88% of women with pure SUI symptoms and 86% of women with MUI symptoms were ‘very much better’ or ‘much better’ after surgery. These rates agree with data published by other authors that also include different types of anti-incontinence surgery with slings [13]. The degree of correlation between the two questionnaires that provide overall results was moderate for both the pure SUI and the MUI groups. Frick et al. [18] analyzed the degree of correlation between the PGI-I and different UI evaluation instruments, including the Pelvic Floor Distress Inventory 20 score, that do not evaluate UI symptoms exclusively. The degree of correlation, while statistically significant, was lower compared with the present study. The degree of correlation is important because patient satisfaction with surgery is a key element in evaluation [1]. Another interesting aspect of this study is the cure rate of the urge component in patients undergoing SUI surgery. Sixty-one percent of patients diagnosed with MUI reported that they did not have UUI following anti-incontinence surgery. This has also been indicated by other authors. Tahseen and Reid [19] reported an urge cure rate of 43% in patients undergoing surgery for SUI using a transobturator technique, whereas Segal et al. [20] reported an urge cure rate of 63% after a TVT-type retropubic sling was fitted.
Table 5 Degree of agreement between objective (stress test) and subjective (symptoms of stress urinary incontinence) measures for the evaluation of cure of the stress component of urinary incontinence. Group with pure SUI (n = 116)
Objective cure ‘no’ Objective cure ‘yes’
Group with MUI (n = 161)
Subjective cure ‘no’
Subjective cure ‘yes’
Subjective cure ‘no’
Subjective cure ‘yes’
7 9
1 99
8 13
7 133
kappa = 0.541 (p < 0.001) SUI, stress urinary incontinence; MUI, mixed urinary incontinence.
kappa = 0.377 (p < 0.001)
I. Diez-Itza, M. Espun˜a-Pons / European Journal of Obstetrics & Gynecology and Reproductive Biology 180 (2014) 68–71
Several theories have been proposed to explain these results, such as the suburethral sling may stabilize the bladder neck, preventing the stretching of pelvic nerves that could be involved in triggering an involuntary detrusor contraction; and the sling may prevent the entry of urine into the proximal urethra, avoiding the sensory stimulation that could promote a reflex detrusor contraction [20]. One of the strengths of this study is its prospective, multicentre design. Thirty-five specialized pelvic floor units in Spain participated, and the three most common minimally invasive surgical techniques for incontinence were performed. This allowed the authors to ascertain the current situation in terms of antiincontinence surgical outcomes in clinical practice in Spain. Another strength of this study is the use of different measures to evaluate outcomes. By doing so, the authors sought to address the concept of cure from different perspectives, demonstrating the variability of cure rates according to the tool used for evaluation, and correlation between the measures. One of the limitations of this study is the short follow-up period for the evaluation of surgical outcomes. Moreover, some patients failed to complete the questionnaires properly. This study is also limited in terms of assessing postsurgical complications. As the complication rate was low, statistical power was insufficient to guarantee that there are no significant differences in the complication rates for the two groups. Despite these limitations, this study demonstrated that there is no single ideal measure for the evaluation of surgical outcomes in patients with pure SUI and MUI, and the degree of agreement between the different OMs varies from moderate to fair. Therefore, caution is recommended when comparing the results of studies using different OMs. One objective measure is not sufficient to detect surgical failures, and no single questionnaire provides sufficient data for subjective evaluation. For patients with pure SUI, the ICIQ-UI SF can identify cases who are totally cured, those who have improved, and those who are the same or worse, and also allows cases to be categorized (before and after surgery) depending on the severity of UI. Nevertheless, when symptoms are mixed, a combination of more than one instrument is ideal. Use of the ICIQ-UI SF, which measures surgical outcomes for UI, with a questionnaire that enables evaluation of the impact of surgery on symptoms (e.g. increased daytime urinary frequency, urgency and urge incontinence) is recommended. Acknowledgements The authors wish to thank all the GISPEM participants for their collaboration and involvement in this study. The work was funded by Astellas Pharma S.A. (Grant no. VH 1-09).
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