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Development of a Patient-Centered Pelvic Floor Complication Scale

Fitzgerald, Jocelyn MD*; Siddique, Moiuri MD, MPH*; Miranne, Jeannine Marie MD, MS; Saunders, Pamela PhD; Gutman, Robert MD*

Female Pelvic Medicine & Reconstructive Surgery: March 14, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/SPV.0000000000000705
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Objective The aim of the study was to evaluate patient responses on a survey of knowledge, perceptions, concerns, and fears about complications related to pelvic reconstructive surgery (PRS). This is the first step to create a simplified, patient-centered Pelvic Floor Complication Scale that evaluates complications from both the patient and surgeon perspective.

Methods Subjects for this prospective study included women older than 18 years planning surgery within 12 weeks or who had undergone PRS more than 6 months ago. Patients were asked open-ended questions about postoperative complications as well as to rank the severity of potential PRS complications (as mild, moderate, severe). Using thematic analysis, responses were coded and analyzed using Dedoose (Version 8.0.35).

Results Thirty-three women (16 preop, 17 postop) participated in telephone interviews (n = 26) and focus groups (n = 7). There were no differences in age, race, education, marital status, and previous surgery. Specific complications such as a single urinary tract infection, short-term constipation (<2 weeks), persistent constipation (present preop), bladder injury not requiring repair or catheterization, vascular injury without sequelae, and extra office visits were considered minor. New recurrent urinary tract infections, new persistent constipation, worsening postop constipation (present preop), blood transfusion, readmission, and reoperation were considered severe complications.

The most common themes included the following: fears of surgical failure, anesthesia, mesh erosion, discharge with a catheter, and pain. Patients were overall very trusting of their female pelvic medicine and reconstructive surgery surgeons and potential risks did not impact surgical decisions.

Conclusions Our research findings provide significant insight into patient perceptions of complications related to PRS that will aid in future development of a patient-centered Pelvic Floor Complication Scale.

From the *Georgetown University/MedStar Washington Hospital Center, Washington, DC;

Harvard Medical School/Brigham and Women’s Hospital, Boston, MA; and

Georgetown University, Washington, DC.

Correspondence: Jocelyn Fitzgerald, MD, Georgetown University/MedStar Washington Hospital Center, 106 Irving St NW, 405 S, Washington, DC 20010. E-mail: jocelyn.j.fitzgerald@medstar.net.

R.E.G. works as a Boston Scientific Site PI for Uphold LITE 522 FDA trial and Strategic Advisory Board Member; Pelvalon Clinical Events Committee Chair (LIBERATE Trial).

This study has been funded in whole or in part with Federal funds Georgetown University and National Center for Advancing Translational Sciences, National Institutes of Health, through the Clinical and Translational Science Awards Program (CTSA) – Pilot and Collaborative Studies Program (Matched Grant funding with MedStar Health Research Institute). Identifying Number: TR000101-04, IRB 2014-0974.

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