European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 177–180
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Fascial surgical repair for vaginal prolapse: effect on quality of life and related symptoms Ma´rcia Silva de Oliveira a,*, Geraldo de Aguiar Cavalcanti a, Aure´lio Antoˆnio Ribeiro da Costa b a b
Universidade de Pernambuco, Recife, Brazil Instituto de Medicina Integral Prof. Fernando Figueira—IMIP, Recife, Brazil
A R T I C L E I N F O
A B S T R A C T
Article history: Received 26 April 2014 Received in revised form 5 August 2014 Accepted 3 September 2014
Objective: The aim of this study was to evaluate the impact of surgical treatment for pelvic organ prolapse (POP) on quality of life and on bladder, vaginal and bowel symptoms using validated questionnaires such as the prolapse quality of life questionnaire (P-QoL). Study design: Sixty-five women underwent surgical POP repair. All were evaluated by physical examination and by the use of ICIQ-VS and P-QoL questionnaires before surgery as well as three and six months after surgery. Results: The preoperative scores of all domains on the ICIQ-VS and P-QoL questionnaires and the scores obtained from quantification of the urinary, sexual and bowel symptoms were higher than those at three and six months after surgery (p < 0.0001). There was no significant difference in the domain scores for the ICIQ-VS and P-QoL questionnaires at three and at six months after surgery (p > 0.05). The preoperative staging was higher than that at three and six months after surgery (p < 0.001), and there was no difference in staging between the two postoperative time points (p > 0.05). Conclusions: Surgery with fascial repair for the treatment of pelvic organ prolapse improved healthrelated quality of life, as assessed by the P-QoL and ICIQ-VS, as well as urinary, vaginal and intestinal symptoms. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Pelvic organ prolapse Quality of life Responsiveness Surgery
Introduction Pelvic organ prolapse is a common condition, and the demand for surgery to repair this condition has increased [1]. Data from the 2005–2006 National Health and Nutrition Examination Survey (NHANES) indicate that 10% of women aged 20 to 39 years and 50% of women older than 79 years experience at least one pelvic floor disorder [2]. The treatment options for prolapse depend on the patient’s expectations and the severity of the symptoms. Although conservative methods such as pelvic floor muscle training, biofeedback, and pessary use are available, surgical repair is a more frequently employed method. Surgery for POP has an important role in gynecological practice due to the increased life expectancy of the female population. This increased life expectancy in turn is due to decreases in hysterectomies and in cervical
* Corresponding author. Tel.: +55 8199225490. E-mail addresses: [email protected], [email protected] (M.S. de Oliveira). http://dx.doi.org/10.1016/j.ejogrb.2014.09.005 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
interventions that occurred after the vaccine for human papilloma virus was introduced [3]. Several surgical procedures are used to correct POP, including the use of mesh and fascial repair [4,5]. POP surgical repair is associated with a moderate risk, with less than 5% perioperative mortality [6]. One of the most important tools for assessing the effects of POP treatments is quality of life (QoL) [4]. Validated questionnaires are used to evaluate the QoL in clinical studies [7] to assess the functional aspects of surgical outcomes [8]. Surgeons must consider the impact of surgery on the patient’s quality of life when making clinical decisions [9]. The objective of this study was to evaluate the effects of surgical repair of POP on related pelvic floor function, symptoms and patient QoL. Materials and methods This cohort study was conducted between May 2011 and August 2013. We enrolled 65 patients who were recruited from two urogynecology referral centers. All patients had relevant POP symptoms requiring surgical repair. Two patients did not undergo surgery and did not return for postoperative evaluation. Women
M.S. de Oliveira et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 177–180
178
Table 1 Sociodemographic characteristics according to the feeling of bulge/lump from or in the vagina, obtained from P-QoL. Feeling a bulge/lump from or in the vagina Characteristics Mean (range)
No
A little
Moderate
A lot
p*
Age BMI Parity Vaginal delivery Cesarean section
53.5 (37–75) 26.6 (20.2–37.3) 3 (1–5) 2 (0–5) 1 (0–2)
64.0 (50–70) 27.1 (21.5–40.4) 4 (2–12) 4 (1–12) 0 (0–1)
58.0 (35–81) 28.4 (23.5–31.9) 3 (1–10) 2 (1–10) 0 (0–1)
67.0 (49–89) 25.1 (16.8–40.8) 5 (0–21) 5 (0–21) 0 (0–2)
0.03 1.00 0.04 0.01 0.02
*
Kruskal–Wallis test.
with any of the following were excluded from the sample: neurological or collagen diseases, HTLV 1 and 2 carrier status, anal incontinence, pregnancy or a history of childbirth or gynecological surgery within 12 months prior to participation in the study. Women with cognitive disabilities that would compromise their comprehension of the questionnaires were also excluded. The study was approved by the IRB (No. 1812). Within a week to 24 h before surgery, sixty-two patients completed the prolapse-quality of life (P-QoL) [9] and international consultation on incontinence-vaginal symptoms (ICIQ-VS) [10] questionnaires, which were previously translated and validated in Portuguese [11,12]. The P-QoL questionnaire included twenty questions representing nine QoL domains as well as questions regarding the patients’ urinary, bowel and sexual functions. The scores for each domain ranged from 0 to 100. The questions on the urinary, bowel and sexual symptoms were not scored in the same way and were instead quantified by means of an arithmetic sum of the responses to each question. Values from 1 to 4 were established for each question on the P-QoL in ascending order of severity. The ICIQ-VS evaluates several topics related to the pelvic floor, such as bowel and bladder problems and sexual dysfunction symptoms. It consists of 14 questions with three independent scores ranging from 0 to 53 (vaginal symptom score), 0 to 58 (sexual dysfunction score) and 0 to 10 (quality of life score). For both questionnaires, a high total score indicates a poor quality of life, while a low score indicates a good quality of life. The questionnaires were read to all patients. After completing the questionnaires, the patients were examined in the lithotomy position using the POP-Q system [13]. The terminology used in the present study was previously described by Haylen et al. [14]. The PQoL and ICIQ-VS questionnaires were applied, and the POP-Q was again assessed at three and six months after surgery. All patients were evaluated in the same position by the same researcher on three separate occasions. The women underwent a variety of surgical procedures for fascial repair. One or more surgical procedures were performed on the same patient. Patients with complaints of urinary incontinence underwent a transobturator sling or Burch colposuspension. Statistical analyses of the preoperative and postoperative data were performed with STATA version 11.0 for linear regression; GraphPad Instat 7.0 software was used to perform the non-parametric Kruskal–Wallis test. A significance level of 5% was employed. To analyze the change in the P-QoL, the pre- and post-treatment scores were compared. Subsequently, the effect size (ES) was measured, which is the mean change in scores divided by the standard deviation of the preoperative values [15]. A value of 0.5 to 0.7 represented moderate responsiveness, 0.8 to 1.0 indicated good responsiveness and higher than 1.0 indicated excellent responsiveness [16].
physical examination and assessment with POP-Q, 23.1% of the women had stage II prolapse, 46.1% had stage III prolapse and 30.8% had stage IV prolapse. Forty-nine (79.0%) women had never undergone procedures to correct prolapse, 58 (93.5%) were postmenopausal and 36 (58.0%) were sexually inactive. Of the women who were not sexually active, 29 (80.5%) were older than 60 years. Women who reported feeling a bulge/lump protruding from or within the vagina were older and had a higher parity than women with fewer symptoms (Table 1). Older women also had more advanced stages of prolapse. A total of 120 procedures were performed and are detailed in Table 2. For analysis of changes in the P-QoL, the data before surgery and six months after treatment were compared. The scores for each domain were lower after surgery than before surgery. Most domains had excellent responsiveness (Table 3). The ‘‘emotion’’ and ‘‘social limitations’’ domains showed good responsiveness (ES = 0.9), and the ‘‘sleep/energy’’ domains showed moderate responsiveness (ES = 0.6). The scores of all P-QoL domains, quantification of bladder, vaginal and bowel symptoms and ICIQ-VS scores were lower in both the third and sixth months after surgical correction than they were before surgery (Tables 4–6). There was no difference between the three- and six-month postoperative scores for either the questionnaires or the symptom measurements. The postoperative POP stage was lower than the POP stage before surgical repair. The median POP stages before surgery, three months after surgical repair and six months after surgical repair were 3 (range 2–4), 2 (range 0–3) and 2 (range 0–3), respectively (p < 0.0001). There was no significant difference between the POP stages observed at three and six months after surgery (p > 0.05). Comment In this cohort study, the impact of surgical treatment for POP was evaluated through the use of validated questionnaires. It was found that both quality of life and POP-related symptoms improved after surgery. Although the majority of validated questionnaires are reliable, their responsiveness (ability to detect changes) can vary [17]. The ICIQ-VS was previously validated in Portuguese, and its responsiveness has been demonstrated [12]. The P-QoL has been validated in ten languages; however, its responsiveness still needs to be established with several validations [17]. The present study demonstrates that the P-QoL can be used to measure changes in response after treatment, Table 2 Frequency of surgeries performed for prolapse—SCP: sacrocolpopexy.
Results All sixty-two women completed the questionnaire preoperatively and at three and six months after surgery. According to
N %
Anterior repair
Posterior repair
SCP
Vaginal hysterectomy
43 69.3
37 59.7
16 25.81
24 38.71
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Table 3 Responsiveness to change: mean change in P-QoL domain scores after surgical treatment and effect size (ES)—SD: Standard deviation.
Prolapse impact Role limitations Physical limitations Social limitations Personal relationships Emotion Sleep/energy Severity measures
Pre-treatment mean score
Post-treatment mean score (6 month)
76.92 46.67 48.46 30.94 60.75 43.08 25.90 28.97
8.06 2.69 2.69 2.15 10.29 6.63 6.99 3.09
confirming the responsiveness of this Portuguese version for Brazilian women. After fascial POP repair in this study, there was significant improvement in the scores for all domains of the P-QoL and ICIQVS. Improvement was also noted in bladder, sexual and bowel symptoms, which were also evaluated by the P-QoL, and in the staging of prolapse, which was assessed according to the POP-Q. This improvement was significant at three and six months after surgical correction of the prolapse when compared to the preoperative assessment. Other studies have also shown that surgery has a positive impact on the quality of life and symptoms associated with POP. A recent meta-analysis of the postoperative quality of life showed that surgery improves the quality of life in women with prolapse [4]. Another study using a similar methodology evaluated 43 women and identified significant improvement at six months after sacrocolpopexy in all areas of the P-QoL, except for the domain ‘‘social limitations’’ [18]. Another study evaluated 4652 women undergoing surgery for POP between 2006 and 2011; the authors compared preoperative ICIQ-VS scores with scores collected in a period ranging from three to six months after surgery and observed improved scores in 80% of the cases [19]. All these studies demonstrate the effectiveness of POP repair
Mean change in scores 68.86 43.98 45.77 28.79 50.46 36.45 18.91 25.88
SD
ES
31.14 39.99 40.26 32.48 38.62 40.61 31.18 23.94
2.2 1.1 1.1 0.9 1.3 0.9 0.6 1.1
surgery as well as the ability of the P-QoL and ICIQ-VS to assess changes after surgery. A longitudinal study involving 177 patients with stages 3 and 4 prolapse also showed improvement in the QoL scores for up to three months after surgery for POP [20]. Similar findings were also observed in another cohort, in which the results of surgery with anterior and posterior repair with or without hysterectomy fascial repair were evaluated. In that study, the P-QoL was used to assess the QoL before surgery and six months after surgery, and it was found that site-specific fascial repair improved the quality of life in most areas based on the questionnaire [1]. The agreement between the results in that cohort and those in this study emphasizes the benefit of surgical repair for POP patients. This study is the first to concurrently use questionnaires regarding symptoms and quality of life for evaluating the response of POP patients to treatment. The use of both questionnaires in the same group of patients may increase our understanding of the effect of treatment on the different aspects of the quality of life and symptoms associated with POP. A study conducted in England that included 192 women who underwent fascial surgery for symptomatic POP describes the use of the P-QoL preoperatively and six months after surgery. As in the
Table 4 Scores of domains of P-QoL preoperatively and, 3 and 6 months after surgical repair. Domains
Preoperative A
3 Months post-operative B
6 Months post-operative C
p Value*
General health perception Prolapse impact Role limitations Physical limitations Social limitations Personal relationships Emotion Sleep/energy Severity measures
42.4 19.8 [50.0] (25–100)
24.6 12.7 [25.0] (0–50)
25.4 15.9 [25.0] ( 25–75)
0.05
8.7 21.9 3.3 14.9 3.3 15.8 2.7 13.7 12.1 26.3
0.05
0.05 0.05 0.05
(): Mean standard deviation []: median, ( ): interval, P-Qol: prolapse-quality of life questionnaire. * Kruskal–Wallis test.
Table 5 Quantification of bladder symptoms. Vaginal and bowel P-QoL staging of prolapse (POP-Q) preoperatively and 3 and 6 months after surgical repair—P-Qol: prolapse-quality of life questionnaire.
Bladder symptoms Vaginal symptoms Bowel symptoms *
Preoperative A
3 Months post-operative B
6 Months post-operative C
p Value*
17.1 5.9 [18.0] (0–28) 13.9 4.8 [14.0] (0–23) 11.0 3.5 [11.0] (0–18)
9.0 4.4 [8.0] (0–23) 5.8 2.7 [5.0] (0–20) 7.8 3.6 [7.0] (0–16)
8.9 4.7 [7.0] (0–23) 5.7 2.8 [6.0] (0–20) 7.3 3.7 [6.5] (0–16)
0.05 0.05 0.05
Kruskal–Wallis () test: mean standard deviation; []: median, ( ): interval.
180
M.S. de Oliveira et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 177–180
Table 6 Scores of areas of the ICIQ-VS preoperatively and 3 and 6 months after surgical repair—ICIQ-VS: international consultation on incontinence questionnaire-vaginal symptoms. Domains
Preoperative A
3 Months post-operative B
6 Months post-operative C
p Value*
Vaginal symptoms score Sexual matter score Quality of life score
24.2 10.9 [24.0] (0–50)
2.5 7.4 [0] (0–50)
2.8 7.7 [0] (0–50)
0.05
13.1 22.0 [0] (0–73) 7.5 3.3 [10.0] (0–10)
3.4 9.6 [0] (0–48) 0.7 1.9 [0] (0–9)
6.3 17.0 [0] (0–74) 1.0 2.4 [0] (0–10)
0.02 A B < 0.05 B C > 0.05 0.05
*
Kruskal–Wallis () test: mean standard deviation []: median, (–): range.
present study, this previous study evaluated the effects of surgery on quality of life and the associated symptoms [1]. Similar to our study, the authors found improvement in bladder, vaginal and bowel symptoms after surgery. There was no difference in the questionnaire scores or POP staging between three and six months after surgical repair, indicating the stability of the surgical results in the first six months after surgical repair. In other studies evaluating the effects of surgical fascial repair on the quality of life, the patients were studied for the following periods of time: three months after surgery [20] and six months after surgery [1]. Long-term studies should be performed to evaluate the permanence of the benefits of fascial surgical repair for POP. The present study has some limitations. The small sample size and the variability of the surgical interventions in addition to the two different anti-incontinence procedures (Sling or Burch) are the major weaknesses of this study. However, the aim of this study was evaluate the extent to which fascial repair (with any surgical technique) could improve QoL and symptoms. Moreover, the questionnaires we used were designed to be self-administered. However, due to the high rate of illiteracy in the population we studied, we chose to read the questionnaires to all of the patients. The researchers who conducted the interviews were trained to maintain uniformity in the mode of application. The high number of sexually inactive women led to difficulties in the assessment of their sexual function. Recent studies have shown improvement in sexual function after POP surgery [21,22], especially when hysterectomy was not performed [22]. Although the sexual complaint scores in the ICIQ-VS and the ‘‘personal relationships’’ domain scores from the P-QoL (which contained questions on sexual function) have shown significant improvement after surgery, we evaluated few sexually active women. The postoperative evaluation period was relatively short, and the long-term results, both anatomical and subjective, must be established. Future studies in a larger population, including more sexually active women, are needed to confirm the permanence of the benefits of fascial surgery to POP patients and the potential utility of other questionnaires that are easy to administer [23]. Bladder, vaginal and bowel symptoms and QoL in women with POP were assessed using the P-QoL and ICIQ-VS, and it was found that these factors improved after fascial surgical repair during the study period. These results demonstrate that POP surgery with fascial repair is effective for patients with pelvic floor dysfunction. This study also highlights the importance of using QoL instruments in the evaluation of surgical treatment outcomes of women with POP. In the present study, the responsiveness of the Portuguese version of the P-QoL has been demonstrated; therefore, this questionnaire can be used to assess treatment outcomes in Brazilian women.
References [1] Fayyad AM, Redhead E, Awan N, et al. Symptomatic and quality of life outcomes after site-specific fascial reattachment for pelvic organ prolapse repair. Int Urogynecol J 2008;19:191–7. [2] Nygaard I, Barber MD, Burgio KL, et al. Pelvic floor disorders network prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008;300(11): 1311–6. [3] Maher C. ICI 2012: pelvic organ prolapse surgery. Int Urogynecol J 2013;24(11):1781. [4] Doaee M, Moradi-Lakeh M, Nourmohammadi A, et al. Management of pelvic organ prolapse and quality of life: a systematic review and meta-analysis. Int Urogynecol J 2014;25(2):153–63. [5] Lensen ETM, Withagen MIJ, Kluivers KB, et al. Surgical treatment of pelvic organ prolapse: a historical review with emphasis on the anterior compartment. Int Urogynecol J 2013;24:1593–602. [6] Gerten KA, Richter HE. Pelvic floor surgery in the older women. Clin Obstet Gynecol 2007;50(3):826–43. [7] Fayyad A, Hill S, Gurung V, et al. How accurate is symptomatic and clinical evaluation of prolapse prior to surgical repair. Int Urogynecol J 2007;18:1179–83. [8] Boer TA, Gietelink DA, Vierhout ME. Discrepancies between physician interview and a patient self-assessment questionnaire after surgery for POP. Int Urogynecol J 2008;19:1349–52. [9] Dua A, Radley S, Jones G, Farkas A. The personal impact of pelvic floor symptom and their relationship to age. Int Urogynecol J 2014;25(1):117–21. [10] Price N, Jackson SR, Avery K, et al. Development and psycometric evaluation of the ICIQ vaginal symptoms questionnaire: the ICIQ-VS. BJOG 2006;113(6):700–12. [11] Oliveira MS, Tamanini JTN, Cavalcanti GA. Validation of the prolapse qualityof-life questionnaire (P-QoL) in Portuguese version in Brazilian women. Int Urogynecol J 2009;20:1191–202. [12] Tamanini JTN, Almeida FG, Girotti ME, Riccetto CLZ, Palma PCR, Rios LAS. The Portuguese validation of the international consultation on incontinence questionnaire-vaginal symptoms (ICIQ-VS) for Brazilian women with pelvic organ prolapse. Int Urogynecol J 2008;19(10):1385–91. [13] Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7. [14] Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J Pelvic Floor Dysfunct 2010;21(1):5–26. [15] Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989;27:178–89. [16] Crosby RD, Kolotkin RL, Rhys Willisams G. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003;56:395–407. [17] Parker-Autry CY, Barber MD, Kenton K, Richter HE. Measuring outcomes in urogynecological surgery: perspective is everything. Int Urogynecol J 2013;24:15–25. [18] Claerhout F, Moons P, Ghesquiere S, et al. Validity, reliability and responsiveness of a Dutch version of the prolapse quality of life (P-QoL) questionnaire. Int Urogynecol J 2010;21:569–79. [19] Guldberg R, Kesmodel US, Hansen JK, et al. Patient reported outcome measures in women undergoing surgery for urinary incontinence and pelvic organ prolapse in Denmark, 2006–2011. Int Urogynecol J 2013;24:1127–34. [20] Dhital R, Otsuka K, Poudel KC, et al. Improved quality of life after surgery for pelvic organ prolapse in Nepalese women. BMC Women’s Health 2013;9:13–22. [21] Srikrishna S, Robinson D, Cardozo L, Gonzalez J. Can sex survive pelvic floor surgery. Int Urogynecol J 2010;21:1313–9. [22] Costantini E, Porena M, Lazzeri M, et al. Changes in female sexual function after pelvic organ prolapse repair: role of hysterectomy. Int Urogynecol J 2013;24:1481–7. [23] Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J 2010;21(5):523–8.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Fascial surgical repair for vaginal prolapse: effect on quality of life and related symptoms Ma´rcia Silva de Oliveira a,*, Geraldo de Aguiar Cavalcanti a, Aure´lio Antoˆnio Ribeiro da Costa b a b
Universidade de Pernambuco, Recife, Brazil Instituto de Medicina Integral Prof. Fernando Figueira—IMIP, Recife, Brazil
A R T I C L E I N F O
A B S T R A C T
Article history: Received 26 April 2014 Received in revised form 5 August 2014 Accepted 3 September 2014
Objective: The aim of this study was to evaluate the impact of surgical treatment for pelvic organ prolapse (POP) on quality of life and on bladder, vaginal and bowel symptoms using validated questionnaires such as the prolapse quality of life questionnaire (P-QoL). Study design: Sixty-five women underwent surgical POP repair. All were evaluated by physical examination and by the use of ICIQ-VS and P-QoL questionnaires before surgery as well as three and six months after surgery. Results: The preoperative scores of all domains on the ICIQ-VS and P-QoL questionnaires and the scores obtained from quantification of the urinary, sexual and bowel symptoms were higher than those at three and six months after surgery (p < 0.0001). There was no significant difference in the domain scores for the ICIQ-VS and P-QoL questionnaires at three and at six months after surgery (p > 0.05). The preoperative staging was higher than that at three and six months after surgery (p < 0.001), and there was no difference in staging between the two postoperative time points (p > 0.05). Conclusions: Surgery with fascial repair for the treatment of pelvic organ prolapse improved healthrelated quality of life, as assessed by the P-QoL and ICIQ-VS, as well as urinary, vaginal and intestinal symptoms. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Pelvic organ prolapse Quality of life Responsiveness Surgery
Introduction Pelvic organ prolapse is a common condition, and the demand for surgery to repair this condition has increased [1]. Data from the 2005–2006 National Health and Nutrition Examination Survey (NHANES) indicate that 10% of women aged 20 to 39 years and 50% of women older than 79 years experience at least one pelvic floor disorder [2]. The treatment options for prolapse depend on the patient’s expectations and the severity of the symptoms. Although conservative methods such as pelvic floor muscle training, biofeedback, and pessary use are available, surgical repair is a more frequently employed method. Surgery for POP has an important role in gynecological practice due to the increased life expectancy of the female population. This increased life expectancy in turn is due to decreases in hysterectomies and in cervical
* Corresponding author. Tel.: +55 8199225490. E-mail addresses: [email protected], [email protected] (M.S. de Oliveira). http://dx.doi.org/10.1016/j.ejogrb.2014.09.005 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.
interventions that occurred after the vaccine for human papilloma virus was introduced [3]. Several surgical procedures are used to correct POP, including the use of mesh and fascial repair [4,5]. POP surgical repair is associated with a moderate risk, with less than 5% perioperative mortality [6]. One of the most important tools for assessing the effects of POP treatments is quality of life (QoL) [4]. Validated questionnaires are used to evaluate the QoL in clinical studies [7] to assess the functional aspects of surgical outcomes [8]. Surgeons must consider the impact of surgery on the patient’s quality of life when making clinical decisions [9]. The objective of this study was to evaluate the effects of surgical repair of POP on related pelvic floor function, symptoms and patient QoL. Materials and methods This cohort study was conducted between May 2011 and August 2013. We enrolled 65 patients who were recruited from two urogynecology referral centers. All patients had relevant POP symptoms requiring surgical repair. Two patients did not undergo surgery and did not return for postoperative evaluation. Women
M.S. de Oliveira et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 182 (2014) 177–180
178
Table 1 Sociodemographic characteristics according to the feeling of bulge/lump from or in the vagina, obtained from P-QoL. Feeling a bulge/lump from or in the vagina Characteristics Mean (range)
No
A little
Moderate
A lot
p*
Age BMI Parity Vaginal delivery Cesarean section
53.5 (37–75) 26.6 (20.2–37.3) 3 (1–5) 2 (0–5) 1 (0–2)
64.0 (50–70) 27.1 (21.5–40.4) 4 (2–12) 4 (1–12) 0 (0–1)
58.0 (35–81) 28.4 (23.5–31.9) 3 (1–10) 2 (1–10) 0 (0–1)
67.0 (49–89) 25.1 (16.8–40.8) 5 (0–21) 5 (0–21) 0 (0–2)
0.03 1.00 0.04 0.01 0.02
*
Kruskal–Wallis test.
with any of the following were excluded from the sample: neurological or collagen diseases, HTLV 1 and 2 carrier status, anal incontinence, pregnancy or a history of childbirth or gynecological surgery within 12 months prior to participation in the study. Women with cognitive disabilities that would compromise their comprehension of the questionnaires were also excluded. The study was approved by the IRB (No. 1812). Within a week to 24 h before surgery, sixty-two patients completed the prolapse-quality of life (P-QoL) [9] and international consultation on incontinence-vaginal symptoms (ICIQ-VS) [10] questionnaires, which were previously translated and validated in Portuguese [11,12]. The P-QoL questionnaire included twenty questions representing nine QoL domains as well as questions regarding the patients’ urinary, bowel and sexual functions. The scores for each domain ranged from 0 to 100. The questions on the urinary, bowel and sexual symptoms were not scored in the same way and were instead quantified by means of an arithmetic sum of the responses to each question. Values from 1 to 4 were established for each question on the P-QoL in ascending order of severity. The ICIQ-VS evaluates several topics related to the pelvic floor, such as bowel and bladder problems and sexual dysfunction symptoms. It consists of 14 questions with three independent scores ranging from 0 to 53 (vaginal symptom score), 0 to 58 (sexual dysfunction score) and 0 to 10 (quality of life score). For both questionnaires, a high total score indicates a poor quality of life, while a low score indicates a good quality of life. The questionnaires were read to all patients. After completing the questionnaires, the patients were examined in the lithotomy position using the POP-Q system [13]. The terminology used in the present study was previously described by Haylen et al. [14]. The PQoL and ICIQ-VS questionnaires were applied, and the POP-Q was again assessed at three and six months after surgery. All patients were evaluated in the same position by the same researcher on three separate occasions. The women underwent a variety of surgical procedures for fascial repair. One or more surgical procedures were performed on the same patient. Patients with complaints of urinary incontinence underwent a transobturator sling or Burch colposuspension. Statistical analyses of the preoperative and postoperative data were performed with STATA version 11.0 for linear regression; GraphPad Instat 7.0 software was used to perform the non-parametric Kruskal–Wallis test. A significance level of 5% was employed. To analyze the change in the P-QoL, the pre- and post-treatment scores were compared. Subsequently, the effect size (ES) was measured, which is the mean change in scores divided by the standard deviation of the preoperative values [15]. A value of 0.5 to 0.7 represented moderate responsiveness, 0.8 to 1.0 indicated good responsiveness and higher than 1.0 indicated excellent responsiveness [16].
physical examination and assessment with POP-Q, 23.1% of the women had stage II prolapse, 46.1% had stage III prolapse and 30.8% had stage IV prolapse. Forty-nine (79.0%) women had never undergone procedures to correct prolapse, 58 (93.5%) were postmenopausal and 36 (58.0%) were sexually inactive. Of the women who were not sexually active, 29 (80.5%) were older than 60 years. Women who reported feeling a bulge/lump protruding from or within the vagina were older and had a higher parity than women with fewer symptoms (Table 1). Older women also had more advanced stages of prolapse. A total of 120 procedures were performed and are detailed in Table 2. For analysis of changes in the P-QoL, the data before surgery and six months after treatment were compared. The scores for each domain were lower after surgery than before surgery. Most domains had excellent responsiveness (Table 3). The ‘‘emotion’’ and ‘‘social limitations’’ domains showed good responsiveness (ES = 0.9), and the ‘‘sleep/energy’’ domains showed moderate responsiveness (ES = 0.6). The scores of all P-QoL domains, quantification of bladder, vaginal and bowel symptoms and ICIQ-VS scores were lower in both the third and sixth months after surgical correction than they were before surgery (Tables 4–6). There was no difference between the three- and six-month postoperative scores for either the questionnaires or the symptom measurements. The postoperative POP stage was lower than the POP stage before surgical repair. The median POP stages before surgery, three months after surgical repair and six months after surgical repair were 3 (range 2–4), 2 (range 0–3) and 2 (range 0–3), respectively (p < 0.0001). There was no significant difference between the POP stages observed at three and six months after surgery (p > 0.05). Comment In this cohort study, the impact of surgical treatment for POP was evaluated through the use of validated questionnaires. It was found that both quality of life and POP-related symptoms improved after surgery. Although the majority of validated questionnaires are reliable, their responsiveness (ability to detect changes) can vary [17]. The ICIQ-VS was previously validated in Portuguese, and its responsiveness has been demonstrated [12]. The P-QoL has been validated in ten languages; however, its responsiveness still needs to be established with several validations [17]. The present study demonstrates that the P-QoL can be used to measure changes in response after treatment, Table 2 Frequency of surgeries performed for prolapse—SCP: sacrocolpopexy.
Results All sixty-two women completed the questionnaire preoperatively and at three and six months after surgery. According to
N %
Anterior repair
Posterior repair
SCP
Vaginal hysterectomy
43 69.3
37 59.7
16 25.81
24 38.71
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179
Table 3 Responsiveness to change: mean change in P-QoL domain scores after surgical treatment and effect size (ES)—SD: Standard deviation.
Prolapse impact Role limitations Physical limitations Social limitations Personal relationships Emotion Sleep/energy Severity measures
Pre-treatment mean score
Post-treatment mean score (6 month)
76.92 46.67 48.46 30.94 60.75 43.08 25.90 28.97
8.06 2.69 2.69 2.15 10.29 6.63 6.99 3.09
confirming the responsiveness of this Portuguese version for Brazilian women. After fascial POP repair in this study, there was significant improvement in the scores for all domains of the P-QoL and ICIQVS. Improvement was also noted in bladder, sexual and bowel symptoms, which were also evaluated by the P-QoL, and in the staging of prolapse, which was assessed according to the POP-Q. This improvement was significant at three and six months after surgical correction of the prolapse when compared to the preoperative assessment. Other studies have also shown that surgery has a positive impact on the quality of life and symptoms associated with POP. A recent meta-analysis of the postoperative quality of life showed that surgery improves the quality of life in women with prolapse [4]. Another study using a similar methodology evaluated 43 women and identified significant improvement at six months after sacrocolpopexy in all areas of the P-QoL, except for the domain ‘‘social limitations’’ [18]. Another study evaluated 4652 women undergoing surgery for POP between 2006 and 2011; the authors compared preoperative ICIQ-VS scores with scores collected in a period ranging from three to six months after surgery and observed improved scores in 80% of the cases [19]. All these studies demonstrate the effectiveness of POP repair
Mean change in scores 68.86 43.98 45.77 28.79 50.46 36.45 18.91 25.88
SD
ES
31.14 39.99 40.26 32.48 38.62 40.61 31.18 23.94
2.2 1.1 1.1 0.9 1.3 0.9 0.6 1.1
surgery as well as the ability of the P-QoL and ICIQ-VS to assess changes after surgery. A longitudinal study involving 177 patients with stages 3 and 4 prolapse also showed improvement in the QoL scores for up to three months after surgery for POP [20]. Similar findings were also observed in another cohort, in which the results of surgery with anterior and posterior repair with or without hysterectomy fascial repair were evaluated. In that study, the P-QoL was used to assess the QoL before surgery and six months after surgery, and it was found that site-specific fascial repair improved the quality of life in most areas based on the questionnaire [1]. The agreement between the results in that cohort and those in this study emphasizes the benefit of surgical repair for POP patients. This study is the first to concurrently use questionnaires regarding symptoms and quality of life for evaluating the response of POP patients to treatment. The use of both questionnaires in the same group of patients may increase our understanding of the effect of treatment on the different aspects of the quality of life and symptoms associated with POP. A study conducted in England that included 192 women who underwent fascial surgery for symptomatic POP describes the use of the P-QoL preoperatively and six months after surgery. As in the
Table 4 Scores of domains of P-QoL preoperatively and, 3 and 6 months after surgical repair. Domains
Preoperative A
3 Months post-operative B
6 Months post-operative C
p Value*
General health perception Prolapse impact Role limitations Physical limitations Social limitations Personal relationships Emotion Sleep/energy Severity measures
42.4 19.8 [50.0] (25–100)
24.6 12.7 [25.0] (0–50)
25.4 15.9 [25.0] ( 25–75)
0.05
8.7 21.9 3.3 14.9 3.3 15.8 2.7 13.7 12.1 26.3
0.05
0.05 0.05 0.05
(): Mean standard deviation []: median, ( ): interval, P-Qol: prolapse-quality of life questionnaire. * Kruskal–Wallis test.
Table 5 Quantification of bladder symptoms. Vaginal and bowel P-QoL staging of prolapse (POP-Q) preoperatively and 3 and 6 months after surgical repair—P-Qol: prolapse-quality of life questionnaire.
Bladder symptoms Vaginal symptoms Bowel symptoms *
Preoperative A
3 Months post-operative B
6 Months post-operative C
p Value*
17.1 5.9 [18.0] (0–28) 13.9 4.8 [14.0] (0–23) 11.0 3.5 [11.0] (0–18)
9.0 4.4 [8.0] (0–23) 5.8 2.7 [5.0] (0–20) 7.8 3.6 [7.0] (0–16)
8.9 4.7 [7.0] (0–23) 5.7 2.8 [6.0] (0–20) 7.3 3.7 [6.5] (0–16)
0.05 0.05 0.05
Kruskal–Wallis () test: mean standard deviation; []: median, ( ): interval.
180
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Table 6 Scores of areas of the ICIQ-VS preoperatively and 3 and 6 months after surgical repair—ICIQ-VS: international consultation on incontinence questionnaire-vaginal symptoms. Domains
Preoperative A
3 Months post-operative B
6 Months post-operative C
p Value*
Vaginal symptoms score Sexual matter score Quality of life score
24.2 10.9 [24.0] (0–50)
2.5 7.4 [0] (0–50)
2.8 7.7 [0] (0–50)
0.05
13.1 22.0 [0] (0–73) 7.5 3.3 [10.0] (0–10)
3.4 9.6 [0] (0–48) 0.7 1.9 [0] (0–9)
6.3 17.0 [0] (0–74) 1.0 2.4 [0] (0–10)
0.02 A B < 0.05 B C > 0.05 0.05
*
Kruskal–Wallis () test: mean standard deviation []: median, (–): range.
present study, this previous study evaluated the effects of surgery on quality of life and the associated symptoms [1]. Similar to our study, the authors found improvement in bladder, vaginal and bowel symptoms after surgery. There was no difference in the questionnaire scores or POP staging between three and six months after surgical repair, indicating the stability of the surgical results in the first six months after surgical repair. In other studies evaluating the effects of surgical fascial repair on the quality of life, the patients were studied for the following periods of time: three months after surgery [20] and six months after surgery [1]. Long-term studies should be performed to evaluate the permanence of the benefits of fascial surgical repair for POP. The present study has some limitations. The small sample size and the variability of the surgical interventions in addition to the two different anti-incontinence procedures (Sling or Burch) are the major weaknesses of this study. However, the aim of this study was evaluate the extent to which fascial repair (with any surgical technique) could improve QoL and symptoms. Moreover, the questionnaires we used were designed to be self-administered. However, due to the high rate of illiteracy in the population we studied, we chose to read the questionnaires to all of the patients. The researchers who conducted the interviews were trained to maintain uniformity in the mode of application. The high number of sexually inactive women led to difficulties in the assessment of their sexual function. Recent studies have shown improvement in sexual function after POP surgery [21,22], especially when hysterectomy was not performed [22]. Although the sexual complaint scores in the ICIQ-VS and the ‘‘personal relationships’’ domain scores from the P-QoL (which contained questions on sexual function) have shown significant improvement after surgery, we evaluated few sexually active women. The postoperative evaluation period was relatively short, and the long-term results, both anatomical and subjective, must be established. Future studies in a larger population, including more sexually active women, are needed to confirm the permanence of the benefits of fascial surgery to POP patients and the potential utility of other questionnaires that are easy to administer [23]. Bladder, vaginal and bowel symptoms and QoL in women with POP were assessed using the P-QoL and ICIQ-VS, and it was found that these factors improved after fascial surgical repair during the study period. These results demonstrate that POP surgery with fascial repair is effective for patients with pelvic floor dysfunction. This study also highlights the importance of using QoL instruments in the evaluation of surgical treatment outcomes of women with POP. In the present study, the responsiveness of the Portuguese version of the P-QoL has been demonstrated; therefore, this questionnaire can be used to assess treatment outcomes in Brazilian women.
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