The present pilot study demonstrates that quality of life of patients with advanced stage of genital prolapse was improved by surgery and indicates that the PFIQ-7 is the most appropriate questionnaire to identify patients that could benefit from surgery.
The aim of genital prolapse surgery is not only anatomical correction but also to improve functional symptoms and quality of life. A recent Cochrane review of the surgical management of genital prolapse noted that the impact of surgery on associated pelvic floor symptoms and quality of life were poorly reported explaining why it is difficult to identify good candidates for this functional surgery [20
]. After failure of perineal rehabilitation and the use of pessaries, current recommendations suggest that surgery should be an option for women with advanced stages of genital prolapse. But the use of exclusive anatomical criteria seems questionable as no strict relation exists between anatomical correction and improvement in symptoms and quality of life [21
]. Visual analogue scales assessing the intensity of symptoms associated with genital prolapse could be used but to date there are no guidelines as to the threshold at which surgery is recommended. Moreover, particularly for patients with endometriosis, a low correlation between evaluation of symptoms by visual analogue scale and changes in quality of life after surgery has been shown [23
]. On the other hand, the usefulness of quality of life questionnaires for selecting patients who could derive benefit from surgery has already been demonstrated [23
]. Recently, several reports have demonstrated the very good psychometric properties of quality of life questionnaires to evaluate the impact of genital prolapse with a Cronbach's alpha greater than 0.70 for all items, confirming that questionnaires are able to detect changes in quality-of-life after treatment [24
]. However, to our knowledge, no study has attempted to assess the contribution of quality of life questionnaires specific to genital prolapse to identify good candidates for surgery.
Analysis of the pre- and postoperative values of the PFDI-20 showed that all 16 patients of this pilot study experienced an improvement in quality of life. These results are consistent with those of previous reports showing the positive impact of genital prolapse surgery [26
]. In a review of the literature on laparoscopic treatment of genital prolapse, Ganatra et al. reported a patient satisfaction of 94.4% with a median follow-up of 24.6 months [26
]. In addition, our data are consistent with those of retrospective studies demonstrating a significant improvement in quality of life after surgical cure of genital prolapse by both vaginal route and laparoscopy [22
]. Moreover, unlike retrospective series, our study shows an improvement in anorectal symptoms assessed by the sub-questionnaire CRADI-8 [32
]. Similar results were noted using the PFIQ-7 questionnaire. In this pilot study, even if all the patients had advanced genital prolapse stages, a wide spectrum of quality of life questionnaire scores was observed. Scores from the PFDI-20 questionnaire ranged from 33 to 235 (on a scale of 0 to 300). Similarly, the preoperative PFIQ-7 questionnaire scores ranged from 0 to 162. It is important to note that some patients did not report impairment in quality of life related to genital prolapse. The apparent low impact of genital prolapse on sexual quality of life observed in this study suggests that the PISQ-12 questionnaire is not a useful tool to select candidates for genital prolapse surgery. This is in agreement with previous studies showing no improvement or deterioration in the sexual quality of life after genital prolapse cure [21
]. Moreover, the PISQ-12 questionnaire can only be used for sexually active patients.
However, even if postoperative improvement in quality of life has been demonstrated in series of patients, it remains difficult to predict impact on an individual basis. To date, no nomogram or recursive partitioning model to select patients for surgery has been developed. Our results are too preliminary to determine which questionnaire could be used to construct a nomogram predicting good outcome after surgery. However, the PFDI-20 questionnaire has the advantage of giving a wide distribution of preoperative values but with a ratio of pre-over postoperative mean values of 3 (98.5 preoperatively vs 31.8 postoperatively). The PFIQ-7 questionnaire gives preoperative values that are relatively scattered but the pre-over postoperative mean value ratio was 7 (54.5 vs 7.4) suggesting a higher power of discrimination compared to the PFDI-20. Moreover, the PFIQ-7 can identify patients who are not likely to benefit from surgery. Indeed, two of the three patients with a preoperative PFIQ-7 less than or equal to 20 had no improvement in quality of life after surgery while the remaining 13 patients with a preoperative PFIQ-7 above 20 were improved. Our results are in accordance with those of Lawndy et al. [33
] showing that even if no difference was observed in anatomical results, some patients reported the absence of symptoms improvement.
This pilot study therefore gives some important pointers to calculate sample size for a study to build a predictive model of quality of life improvement after genital prolapse cure. Taking into account that two of the 16 patients had no improvement using the PFIQ-7 questionnaire and that at least 50 patients with no improvement are required to built a predictive model, at least 400 patients would be required for such a study.
The limitations of this pilot study should be highlighted. First, the low number of patients may be a potential source of bias. Despite this disadvantage, our pilot study underlined the wide spectrum of preoperative values to quality of life questionnaires in patients with genital prolapse. Even if all our patients had advanced genital prolapse stage, they represented a heterogeneous population underlining that anatomical abnormalities associated with genital prolapse are insufficient to select patients for surgery. Second, two routes for genital prolapse cure were used. It is possible that the type of surgery could influence changes in quality of life. Finally, the short follow-up cannot exclude the risk of overestimating the benefit of surgery.