Associate Professor, Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Washington University School of Medicine, St. Louis, MO

Dr. Ghetti reports no financial relationships relevant to this field of study.

SYNOPSIS: Patients see poor functional outcomes as severe adverse events following pelvic floor surgery.

SOURCE: Dunivan GC, et al. A longitudinal qualitative evaluation of patient perspectives of adverse events after pelvic reconstructive surgery. Int Urogynecol J 2019 Jun 11. doi: 10.1007/s00192-019-03998-7. [Epub ahead of print].

The objective of this study was to describe how patients view adverse events related to pelvic floor surgery and how these perspectives change over the perioperative period. This was a mixed method study that utilized semi-structured patient interviews and patient surveys. All English-speaking women planning to have pelvic floor surgery (urinary incontinence and/or prolapse surgery) were eligible to participate. Each subject completed three separate semi-structured interviews (one preoperatively up to 12 weeks prior to surgery, one six to eight weeks postoperatively, and the third at three months postoperatively). All participants received standard preoperative counseling prior to surgery. At each interview, participants were asked to list anticipated or experienced adverse events. In addition, participants were given a list of events providers categorize as adverse events, and at follow-up interviews were provided their personal initial adverse event list and asked to reflect on any changes. Interviews were audiotaped, transcribed, coded, and analyzed using qualitative iterative process.

Twenty subjects participated in the study. Each subject underwent surgery and completed three interviews. Participants had a mean age of 44 years, half were non-Hispanic white, one-quarter were Hispanic, and 25% were American Indian. Seventy-five percent had a college degree or higher. Subjects underwent a range of major to minor pelvic floor-related procedures including mid-urethral slings, neuromodulation, hysterectomy, and vaginal native tissue repairs.

Subjects’ perceptions of AEs evolved over time. In pre-operative interviews, women listed surgery-related concerns, such as surgical or anesthetic complications, pain, and immediate post-op bladder drainage, as adverse events. At the initial post-operative interview, subjects’ concerns related primarily to functional outcomes, in particular activities of daily living, sexuality, and symptoms relief. At the six-month interview, subjects identified failure to achieve functional goals of surgery, persistent incontinence, and sexual dysfunction as severe adverse events. Women voiced the need to receive additional information regarding what to expect during the perioperative period as well as long-term success and impact of surgery.

COMMENTARY

The main finding of this study is that women’s concept of adverse events changes over time and that the failure to achieve their expected functional goals after surgery represents severe adverse events. This study builds on prior work by authors.¹ Dunivan et al completed focus groups of women preoperatively, within three months postoperatively, and one to five years postoperatively and reported on women’s perspective of adverse events. However, the current study followed subjects longitudinally over preoperative and postoperative time points and therefore explores the evolution of women’s perspectives over time.

Although this study included a small sample, each subject underwent three individual interviews and thematic saturation was achieved. The authors reported that women desired additional information regarding the perioperative expectations and long-term success and effect of surgery. Presenting data separately for subjects undergoing minor vs. major procedures or by indication for surgery could have strengthened the study. In addition, detailed information on standard perioperative counseling, the consent process, and postoperative information provided to subjects would allow readers to better understand findings and consider implementation into clinical practice.

This study confirms findings of prior studies and the importance of functional outcomes for women undergoing pelvic floor surgery in a diverse population. Researchers and clinicians are fortunate to have several validated condition-specific quality of life measures pertinent to the field of female pelvic medicine and reconstructive surgery.^2,3,4 Qualitative studies such as this can provide significant insight into the patient perspective that cannot be gleaned by quantitative measures alone. This study highlights the importance of patient-surgeon communication, thorough patient counseling with clarifying, and setting of clear expectations for patients undergoing reconstructive pelvic surgery.

REFERENCES

1. Dunivan GC, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Gaining the patient perspective on pelvic floor disorders’ surgical adverse events. Am J Obstet Gynecol 2019;220:185.e1-185.e10.
2. Barber MD, et al. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 2001;185:1388-1395.
3. Rogers RG, et al. A new measure of sexual function in women with pelvic floor disorders (PFD): The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J 2013;24:1091-103.
4. Lowder JL, et al. Body image in the Pelvic Organ Prolapse Questionnaire: development and validation. Am J Obstet Gynecol 2014;211:174.e1-9.