Patient-reported outcomes in pelvic organ prolapse repair: the missing information needed to inform our understanding of what matters most to patients

Pelvic organ prolapse (POP) surgery is aimed at improving a woman’s quality of life and treating symptomatic vaginal bulge symptoms. There is no one size fits all surgery for prolapse, and the decision on route and type of surgery is made through shared decision-making with the patient. Increasingly patients’ role has switched from passive recipients of care to active participants, and in turn our ability to counsel and inform the patient of their surgical options is becoming increasingly important.

Our field has focused for some time on comparative effectiveness trials aimed at evaluating the “success” of different surgical approaches for prolapse, however, there has been sizable heterogeneity in the metrics used to define success. Most studies to date are powered to detect differences in objective anatomic measurements, not patient experiences or quality of life. But while loosely related, bother or other prolapse-related symptoms do not correlate directly with the degree of POP (1). Furthermore, studies have shown women with advanced prolapse are more likely to feel self-conscious and less sexually attractive than the controls (2). The decision to proceed with treatment for the condition is based on the magnitude of the prolapse’s impact on the patient’s; thus, it is imperative that measures assessing surgical success center around this outcome, not anatomic measures (3). Few quality measures exist, however, that specifically track patient-reported outcomes (PRO), thus we may be missing what matters most to a patient as we weigh surgical options with them in clinic. As numerous surgical approaches and non-surgical options are available to patients as treatment for POP, we need better information about these subjective, but critically important, PRO to better guide patients toward the right therapeutic approach for each individual.

As we move towards more minimally-invasive, lower risk surgeries, the differences in morbidity risks between surgery become less important than the patient’s perception of surgical recovery and return to function. In a study of patient’s perceptions on adverse events (AEs) following surgery for pelvic floor disorders, women reported dyspareunia as a serious AE, and categorized incontinence, constipation, nocturia, and pain as “very severe”, ranking these comparably to an intensive care unit (ICU) admission (4). In another focus group patients ranked prolapse outcomes in the following order of importance: (I) the resolution of vaginal bulge symptoms, (II) improvement in physical function; (III) improvement in sexual function; (IV) improvement in body image perception; and (V) improvement in social function (5). The International Urogynecological Association (IUGA) recently supported development of a guidance document as part of the International Urogynecological Consultation (IUC) on POP that provided recommendations for evaluating the success in prolapse repair (6). Citing the commonly observed disconnect between anatomic outcomes and symptoms, these recommendations focus on the absence of vaginal bulge symptoms as the most meaningful definition of treatment success. Improvement in vaginal bulge symptoms after prolapse repair, not anatomic measures, has the strongest relationship with a patient’s perception of their overall improvement after surgery (7). Conversely, symptomatic relief and improved quality of life is often achieved and maintained even in patients who have some residual or recurrent POP after repairs (8). Thus, to critically evaluate the surgical care provided, prolapse-related symptoms following surgery must be systematically and rigorously tracked.

In a recent study, Ruseckaite et al. evaluated existing PRO instruments for women undergoing POP procedures (9). After seven standardized symptom questionnaires (PFDI-20, PFIQ-7, P-QOL, PISQ-IR, ICIQ-VS, APFQ, PFBQ) were identified by clinical experts, the authors performed semi-structure qualitative interviews with 15 patients and 11 clinicians. Interview responses were analyzed with a goal of generating consensus on what best encapsulates the patient’s experience postoperatively. Patients expressed the desire for a tool that evaluated their postoperative social and emotional impact, impact on work-related activities, sexual function, bowel and bladder symptoms, while balancing questionnaire length, invasiveness and readability.

The Australian Pelvic Floor Questionnaire (APFQ) was found to be the best tool evaluated in the study, and work is being done to pilot its inclusion in the Australasian Pelvic Floor Procedure Registry (APFPR). The authors concluded that a simple, short, and comprehensive tool covering all aspects of life and daily experience is needed for bowel, bladder, prolapse and sexual function assessment. While their results may be biased by patient selection and the limitation of their analysis to the 7 instruments identified by clinical experts, these findings reflect the common urogynecologic experience that alleviation of the associated symptoms, not the anatomic degree of prolapse, drives patient satisfaction with repair. They have begun piloting the inclusion of the APFQ into the APFPR.

While this study aimed at evaluating existing instruments utility in PRO tracking, others have suggested creating novel tools specifically for PRO registries for POP. The American Urogynecologic Society (AUGS) highlighted the critical need for PRO measures for prolapse during a 2016 and 2019 consensus conference (10,11). Work has been done by this organization to develop a concise yet comprehensive assessment tool for surgical and non-surgical treatment of prolapse. Named AUGS PERFORM (12), this novel tool seeks to assess awareness and bother from prolapse, physical function, physical discomfort during sexual activity, pain, and urinary/defecatory symptoms over 11 questions. This group cautions against measuring outcomes beyond a surgeons’ control (e.g., emotional distress, sexual interest, engagement in social activities) as they are multifactorial and not directly related to the treatment of prolapse. Additionally capturing this data without knowing what the prevalence of these factors are in the general population may overestimate negative or positive consequences of prolapse surgery.

The increasing attention national Urogynecologic organizations have placed on collection of PRO is promising, as we hope to gain the necessary data to inform our patients moving forward. There seems to be universal agreement that subjective prolapse bother, physical and sexual function, and bladder and bowel symptoms should be routinely assessed. The tool for that assessment will likely vary by country and culture, but as long as we are capturing the data, we will not only be able to inform our patients better, but we will also be able to refine our surgical techniques.

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Gynecology and Pelvic Medicine. The article has undergone external peer review.

Peer Review File: Available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-49/prf

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-49/coif). M.T. reports consulting fees from Iota Bioscience and Exploramed development. M.T. also reports payment received for writing of Clinical Key on pelvic organ prolapse from Elsevier. A.L.A. reports grants from NIH (NIDDK K08DK118176), Department of Defense (PRMRP W81XWH2110644) and MicrogenDx (Industry Funded Clinical Trial) to institution, consulting fees from Abbvie, payments from AUA, Wood, Smith, Henning, & Berman, Swanson, Martin & Bell, LLP, support for travel from AUA/Urology Care Foundation, and stock options of Watershed Medical. A.L.A. also reports participation on unpaid Advisory Board of Desert Harvest and GlaxoSmithKline, unpaid committee role in SUFU and serving as unpaid committee chair in SIU. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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References

1. Lee U, Raz S. Emerging concepts for pelvic organ prolapse surgery: What is cure? Curr Urol Rep 2011;12:62-7. [Crossref] [PubMed]
2. Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol 2006;194:1455-61. [Crossref] [PubMed]
3. Mattsson NK, Karjalainen PK, Tolppanen AM, et al. Pelvic organ prolapse surgery and quality of life-a nationwide cohort study. Am J Obstet Gynecol 2020;222:588.e1-588.e10. [Crossref] [PubMed]
4. Dunivan GC, Sussman AL, Jelovsek JE, et al. Gaining the patient perspective on pelvic floor disorders' surgical adverse events. Am J Obstet Gynecol 2019;220:185.e1-185.e10. [Crossref] [PubMed]
5. Sung VW, Rogers RG, Barber MD, et al. Conceptual framework for patient-important treatment outcomes for pelvic organ prolapse. Neurourol Urodyn 2014;33:414-9. [Crossref] [PubMed]
6. Kowalski JT, Barber MD, Klerkx WM, et al. International urogynecological consultation chapter 4.1: definition of outcomes for pelvic organ prolapse surgery. Int Urogynecol J 2023;34:2689-99. [Crossref] [PubMed]
7. Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009;114:600-9. [Crossref] [PubMed]
8. Lee U, Wolff EM, Kobashi KC. Native tissue repairs in anterior vaginal prolapse surgery: examining definitions of surgical success in the mesh era. Curr Opin Urol 2012;22:265-70. [Crossref] [PubMed]
9. Ruseckaite R, Jayasinghe R, Bavor C, et al. Evaluation and acceptability of patient-reported outcome measures in women following pelvic organ prolapse procedures. BMC Health Serv Res 2023;23:624. [Crossref] [PubMed]
10. Siddiqui NY, Dunivan GC, Chermansky CJ, et al. Deciding Our Future: Consensus Conference Summary Report. Female Pelvic Med Reconstr Surg 2020;26:159-61. [Crossref] [PubMed]
11. Siddiqui NY, Gregory WT, Handa VL, et al. American Urogynecologic Society Prolapse Consensus Conference Summary Report. Female Pelvic Med Reconstr Surg 2018;24:260-3. [Crossref] [PubMed]
12. O'Shea M, Boyles S, Bradley CS, et al. AUGS-PERFORM: A New Patient-Reported Outcome Measure to Assess Quality of Prolapse Care. Female Pelvic Med Reconstr Surg 2022;28:468-78. [PubMed]