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. Author manuscript; available in PMC: 2017 Jul 1.
Published in final edited form as: Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):182–189. doi: 10.1097/SPV.0000000000000270

Table 4.

Other Study Measures Captured in the SUPeR Study

  1. Urinary function including: duration of post-op catheterization, de novo voiding dysfunction rates. A post void residual (PVR) was assessed by catheterization or bladder scan at the 6 week visit and an elevated PVR was defined as a volume > 150 ml that was not present preoperatively.

  2. De novo incontinence rates and severity- assessed by the Urogenital Distress Inventory-6 (UDI-6)14, Incontinence Severity Index (ISI)35, and Adverse Event survey.

  3. Quality of life measured in terms of functional activity by administration of the Functional Activity Assessment Scale36, general quality of life as measured by the Short Form -12(SF-12)37, and pelvic function-specific quality of life as measured by the Pelvic Floor Impact Questionnaire Short Form.20

  4. Mesh-related complications: mesh exposure in the vagina or mesh erosion into another organ and the classification of the intervention: a) None or non-surgical medical intervention only, b) Minor or intra-office surgical intervention, c) Outpatient surgery, d) Inpatient surgery

  5. Rates, location, and severity of pelvic pain- using the modified Surgical Pain instrument38, pain medication use, AE survey, and a pain mapping instrument

  6. Pelvic infection

    1. Perioperative infections- defined as requiring antibiotics.

    2. Urinary tract infections- defined as culture proven or antibiotics given

    3. Vaginal infections with flora uncommon to the vaginal canal

  7. Neuromuscular problems (including groin and leg pain) with the use of a pain mapping instrument

  8. Vaginal scarring, Vaginal shortening, de novo dyspareunia, and worsening dyspareunia with AE survey.

  9. Sexual function measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)39

  10. Body image measured by a modified body image scale40

  11. Cost effectiveness analysis - conducted from a payer perspective and expressed as incremental cost required to produce one additional unit of quality-adjusted life year (QALY) based on data collected on: 1) each participant’s use of medical and non-medical resources related to urologic or gynecologic conditions, 2) direct and indirect costs of the treatment of each of the study surgeries, and 3) participants preference for health states for improvement in pelvic organ prolapse.

  12. Post-operative bowel function as measured by the colorectal subscale of the Pelvic Floor Distress Inventory.14