Chronic Pelvic Pain, Quality of Life, and Patient Satisfaction After Robotic Sacrocolpopexy for Pelvic Organ Prolapse

Background and objective When evaluating repair outcomes in robotic sacrocolpopexy (RSC) for the treatment of pelvic organ prolapse (POP), it has become evident that surgeons usually focus on anatomical improvements and neglect equally important parameters of patient satisfaction and quality of life (QoL). Investigating these factors would aid in achieving a more patient-centered approach to treatment. This study aimed to examine QoL and satisfaction outcomes in women after RSC. Methods This study analyzed self-reported patient data regarding RSC for POP performed between October 2009 and February 2017 by fellowship-trained urologists in female pelvic medicine and reconstructive surgery. These patients participated in a survey to assess overall satisfaction and QoL, as well as contributing factors, such as changes in bladder and bowel function, vaginal bulge, and vaginal pain on a 7-point Likert scale (ranging from markedly worse to markedly improved). Data were examined using multivariate regression analysis. Positive treatment response was defined as scores of 6 or 7, whereas negative response was defined as scores of 1 to 5. Results The response rate was 41% (156/380), and the median age of the participants was 70 years [interquartile range (IQR): 63, 73]. Of note, 98.7% were Caucasian, with 73% currently in a significant relationship. The median duration since RSC was 2.12 years (IQR: 1.2, 3.7). Overall, 93 (66.9%), patients (23.0%), and 123 patients (88.5%) had a positive treatment response for bladder function, bowel function, and vaginal bulge, respectively. Furthermore, 66% of women had improved QoL, 84% reported improved overall satisfaction, and 91.4% stated that they would recommend RSC to a friend. After controlling for significant covariates, results of a multivariate analysis demonstrated positive treatment response for bladder function [odds ratio (OR): 14.6; p < 0.0001], bowel function (OR: 9.72; p = 0.003), and vaginal bulge (OR: 41.7; p < 0.0001), significantly associated with increased odds of having improved QoL, whereas positive treatment response for vaginal bulge (OR: 26.9; p = 0.023) and recommending RSC to a friend (OR: 175; p = 0.0009) were associated with positive overall satisfaction. Conclusions Our findings endorse using RSC surgery for patients with POP based on both QoL improvement and overall post-procedure satisfaction perspective. This study may help encourage surgeons and clinicians to employ a surgical modality that incorporates each patient’s unique treatment desires and goals and provide patients with realistic post-procedure goals and expectations regarding treatment.


Introduction
Pelvic organ prolapse (POP) occurs when the uterus or vagina descends from its normal anatomical position, and it is associated with a lifetime risk of up to 12% for women by the age of 80 years [1][2][3][4]. Almost one-third of patients with POP complain about their quality of life (QoL) worsening due to the condition [5]. The POP incidence rate is expected to increase in the next 40 years, with as many as five million women estimated to be affected by 2050, with a reoperation rate of 30% [1,6]. Every year, approximately 200,000 procedures are performed for POP, which is calculated to increase by 46% by 2050 [7][8][9]. Age, parity, obesity, pelvic floor injury, connective tissue disorders, hysterectomy, estrogen deficiency, intestinal pathologies, chronic pulmonary disease, and genetics have been previously shown to be risk factors for POP [2,[10][11][12][13][14][15]. The treatment modality to repair POP can be either abdominal or vaginal surgery, with the former approach further sub-classified into open, laparoscopic, and robotic. Surgeons usually choose a treatment modality depending on their comfort level and the patient's comorbidities, age, type of reconstructive procedure, POP extent, the extent of obliterative procedures, and potential complications [16,17].
Since its introduction in 2004, robotic sacrocolpopexy (RSC) has been used to treat POP. Over the years, it has become a widespread and popular treatment option for POP [18]. Compared to other modalities, RSC is less invasive and leads to less perioperative blood loss, lower postoperative pain, quicker return to a normal lifestyle, and reduced complications [19]. Past studies of RSC, which have focused on objective outcomes based on POP-Q stage 1 or less, estimate current anatomical cure rates to be 98.6% [17,20]. To date, research on RSC POP repair has primarily focused on anatomical outcomes; however, little research exists regarding the impact of RSC on functional outcomes [21]. Existing research has focused less on patient satisfaction and QoL and more on quantifiable measures, such as pad weight for incontinence and pelvic organ prolapse quantification (POP-Q) measurements for prolapse. Of late, there has been a greater interest in subjective outcomes due to the emergence of a more patient-centered approach to medicine. Conditions such as POP can limit a patient's interpersonal relationships socially, physically, and psychologically [22]. However, the subjective success of the treatment is not clearly defined. Several studies have used validated questionnaires, such as Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), and Urinary Distress Inventory with a view to quantify patient's symptoms and evaluate subjective success.
However, these validated questionnaires are also problematic in many ways. For instance, many questionnaires are too lengthy for patients to complete, and shorter versions often only identify one symptomatic domain. Clinicians may not accurately understand the patient's overall QoL without additional surveys focusing on various potential POP-related symptoms. Furthermore, the reliability of survey responses may become questionable when the patient population drastically changes or an untested surgical modality is used compared to the initially studied population [15].
This study aims to analyze women's overall satisfaction and QoL following RSC surgery to treat POP. In addition, the influence of symptoms on patients' overall QoL and post-surgery satisfaction will also be assessed.
This article was previously presented as a meeting abstract at the Neurology and Urodynamics Conference in February 2018 [23].

Materials And Methods
This retrospective questionnaire-based study was conducted in the Urology Department of Beaumont Hospital in association with the Michigan Institute of Urology in Royal Oak, Michigan. Institutional Review Board (IRB) approval through Beaumont Hospital was obtained before contacting patients who had undergone RSC treatment for POP (IRB approval number: 2016374). Patients with POP underwent RSC via the standard approach involving the Da Vinci surgical system, performed by fellowship-trained urologists in female pelvic medicine and reconstructive surgery. Concomitant robotic hysterectomy or surgical repair was performed when appropriate. All patients met the criteria for symptomatic vaginal bulge necessitating treatment.
Currently living patients who had been 18 years or older at the time of surgery and who underwent RSC between October 2009 and February 2017 were mailed an investigator-created questionnaire to assess selfreported improvements in QoL and overall satisfaction after RSC. A 7-point Likert Scale measured the degree of improvement in patients' subjective health status after undergoing RSC, including bladder function, bowel function, vaginal bulge, pelvic/vaginal pain, QoL, and overall satisfaction ( Table 1).  Patients were categorized as having a positive treatment response if they indicated that RSC moderately improved or markedly improved their subjective health status. In addition to assessing improvements in subjective health status, the questionnaire further asked patients about demographic information, subsequent surgical history, and whether the patient would recommend RSC to a friend.

7-Point Likert
Data are presented as medians and interquartile ranges (IQR) for continuous variables, while frequencies and percentages show categorical variables. Odds ratios (OR) with corresponding 95% confidence intervals and p-values were generated using univariate Firth logistic regressions to find significant predictors of positive treatment response in terms of QoL and overall satisfaction. Firth logistic regression was used instead of standard logistic regression due to a high prevalence of patients with positive treatment responses for the outcomes of this study. A p-value <0.05 was considered statistically significant. Data analysis was performed using SAS 9.4 (SAS Institute Inc., Cary, NC). The full questionnaire is available from the authors upon request.

Results
Of the 380 patients who were mailed the questionnaire, 156 responded and returned the completed questionnaire (response rate: 41%). Of the 156 returned questionnaires, 17 were excluded from the final data analysis due to incomplete data. The final sample size was 139 patients. The median age of the respondents was 70 years (IQR: 63, 73), while the median duration since RSC was 2.1 years (IQR: 1.2 years, 3.7 years). In addition, 16 patients (11.5%) had undergone at least one related surgery between RSC and responding to the survey ( Table 2).  One patient had an entangled bowel following RSC, requiring emergency surgery and ICU admission for nine days. Overall, 93 (66.9%), 32 (23.0%), and 123 patients (88.5%) had a positive treatment response for bladder function, bowel function, and vaginal bulge, respectively. Of the 57 patients who self-reported pre-RSC pelvic/vaginal pain, 35 patients (61.4%) had a positive treatment response post-procedure. Most patients (91.4%) said they would recommend RSC to a friend. Self-reported patient demographics were stratified according to positive treatment response and non-positive treatment response for QoL and overall satisfaction ( Table 3).

FIGURE 1: Forest Plot for Positive Treatment Response for Quality of Life
Among patients with pelvic/vaginal pain, 87.9% had positive treatment responses for QoL, and this association was also statistically significant (OR: 18.7; p = < 0.0001) (Figure 2).

Response for Overall Satisfaction
Red line: positive treatment response; blue line: non-positive treatment response Current relationship status, education level, and other subsequent surgeries were not associated with positive treatment response for either QoL or overall satisfaction (all p > 0.05). Current employment status was significantly associated with positive treatment response for QoL but not with positive treatment response for overall satisfaction. Patients recommending RSC to friends had significantly increased odds of having positive treatment responses for both QoL and overall satisfaction (p < 0.05).

Discussion
RSC has come to be routinely used for POP; however, subjective measures of surgical satisfaction, including QoL and overall satisfaction, have yet to be evaluated as a primary aim. Our questionnaire was developed to ascertain patients' subjective symptoms after RSC and its influence on their QoL and overall satisfaction. POP affects women's QoL, and it is thus essential to measure QoL when considering a treatment option [24]. QoL was defined as a patient's overall wellbeing with or without distress from their POP, whereas overall satisfaction pertains to how content patients were with RSC surgery when completing their questionnaire.
One important finding was that positive treatment response for bowel function was significantly associated with positive treatment response for QoL and overall satisfaction. Our results show that positive treatment response for bowel function continues for a median duration of 2.1 years, whereas previously published literature had a median one-year follow-up after RSC surgery [25][26][27]. In addition, our results show that only 23% of patients reported positive treatment responses for bowel function, whereas the majority had no changes in bowel function. This suggests that RSC surgery dramatically affects the QoL of a minority of patients, who are symptomatic of bowel dysfunction caused by their POP.
Positive treatment response for vaginal bulge significantly influences QoL and overall satisfaction. This finding supports a previous study, which showed that subjective cure, the absence of bulge symptoms, occurred in 92.1% of patients, compared to 88.5% [28]. The improvement in vaginal bulge symptoms is essential to women's QoL and overall satisfaction, as nearly every patient with positive treatment response in our study also had a positive treatment response for QoL. Likewise, the patient's pelvic/vaginal pain significantly affects her QoL and overall surgical satisfaction. Previous publications have elucidated that RSC is associated with greater inter-and postoperative pain compared to other surgical modalities [29,30]. However, these findings should be interpreted with caution, since our study indicates that only 38.6%