Urinalysis Collection and Results in Pelvic Organ Prolapse
Urinalysis Collection and Results in Pelvic Organ Prolapse
Using a prospective study design, data were collected from 72 consecutive women who presented to an outpatient urogynecologic center with advanced urogenital prolapse between May and September 2011. Institutional Review Board (IRB) approval was obtained, and written consent was secured from all participants prior to the initiation of any study-related activity. Each potential participant provided a detailed health history, underwent a physical examination, and completed the Pelvic Organ Prolapse Quantification (POP-Q) evaluation. POP-Q is a standardized system used to measure the extent of pelvic organ prolapse in patients undergoing urogynecologic evaluation for prolapse. POP-Q has been proven to have strong reproducibility among observers. One study showed statistically significant correlations (p = 0.0008 to < 0.0001) between observers on all nine measurements of the POP-Q evaluation (Hall et al., 1996).
Patients were screened for eligibility by using inclusion and exclusion criteria. If eligible to enroll, the nature and purpose of the study was explained to the patient. Inclusion criteria included being over the age of 18 years, having the ability to provide informed consent, and where the leading edge of their prolapse was to or beyond the vaginal hymen on pelvic examination, this correlates to Stage 2 or greater pelvic organ prolapse. Individuals who were pregnant, or who had a pessary, history of pelvic radiation, or any impairment preventing the ability to perform the MSCC technique were excluded from study participation. Written informed consent was obtained from all 72 potential patients who were solicited for study participation.
No patient refused to be part of the study. All participants were given instructions on how to perform the MSCC technique, and bactericidal wipes were provided. Each participant used the wipes to cleanse the urethra, vagina, and perineum from front to back; spread the labia; and collect a midstream sample into a sterile container. Participants then underwent sterile straight catheterization, and both urine samples were sent for microscopic urinalysis (UA). The urethra was cleansed with antiseptic solution, and a sterile catheter was placed into the urethra and bladder to obtain a urine specimen. There was one clinician who performed sterile straight catheterization. For each participant, the MSCC specimen was compared to the catheterized specimen for all components of the microscopic UA.
The primary outcome variables were the components of a urinalysis. The critical measurements were white blood cell count (WBC), red blood cell count (RBC), bacteria, leukocyte esterase, squamous epithelial cells, and nitrites. WBC, RBC, bacteria, leukocytes esterase, and squamous epithelial cells were ordinal variables. Nitrite was treated as a binary outcome (positive or negative).
The study sample size was 72, which is based on the following argument. According to Cicchetti and Fleiss (1977), the minimal sample size required for the valid application of weighted kappa is 2k, where k is the number of categories. This formula ensures that the calculation, confidence intervals, and p-values. Agreement between urine collection techniques was calculated using weighted and Cohens' kappa (k) for ordinal and binary outcomes respectively. The above analysis was repeated and stratified by type of pelvic organ prolapse; namely, anterior, posterior, and apical.
Significant agreement was determined if the kappa was greater than or equal to 0.75, in accordance with Fleiss (1981). The Wilcoxon signed-rank (WSR) test was used as a paired difference test between urine collection techniques. All analysis was conducted in SAS Version 9.2 (Cary, NC: SAS Institute, 2002–2008).
Methods
Using a prospective study design, data were collected from 72 consecutive women who presented to an outpatient urogynecologic center with advanced urogenital prolapse between May and September 2011. Institutional Review Board (IRB) approval was obtained, and written consent was secured from all participants prior to the initiation of any study-related activity. Each potential participant provided a detailed health history, underwent a physical examination, and completed the Pelvic Organ Prolapse Quantification (POP-Q) evaluation. POP-Q is a standardized system used to measure the extent of pelvic organ prolapse in patients undergoing urogynecologic evaluation for prolapse. POP-Q has been proven to have strong reproducibility among observers. One study showed statistically significant correlations (p = 0.0008 to < 0.0001) between observers on all nine measurements of the POP-Q evaluation (Hall et al., 1996).
Patients were screened for eligibility by using inclusion and exclusion criteria. If eligible to enroll, the nature and purpose of the study was explained to the patient. Inclusion criteria included being over the age of 18 years, having the ability to provide informed consent, and where the leading edge of their prolapse was to or beyond the vaginal hymen on pelvic examination, this correlates to Stage 2 or greater pelvic organ prolapse. Individuals who were pregnant, or who had a pessary, history of pelvic radiation, or any impairment preventing the ability to perform the MSCC technique were excluded from study participation. Written informed consent was obtained from all 72 potential patients who were solicited for study participation.
No patient refused to be part of the study. All participants were given instructions on how to perform the MSCC technique, and bactericidal wipes were provided. Each participant used the wipes to cleanse the urethra, vagina, and perineum from front to back; spread the labia; and collect a midstream sample into a sterile container. Participants then underwent sterile straight catheterization, and both urine samples were sent for microscopic urinalysis (UA). The urethra was cleansed with antiseptic solution, and a sterile catheter was placed into the urethra and bladder to obtain a urine specimen. There was one clinician who performed sterile straight catheterization. For each participant, the MSCC specimen was compared to the catheterized specimen for all components of the microscopic UA.
The primary outcome variables were the components of a urinalysis. The critical measurements were white blood cell count (WBC), red blood cell count (RBC), bacteria, leukocyte esterase, squamous epithelial cells, and nitrites. WBC, RBC, bacteria, leukocytes esterase, and squamous epithelial cells were ordinal variables. Nitrite was treated as a binary outcome (positive or negative).
The study sample size was 72, which is based on the following argument. According to Cicchetti and Fleiss (1977), the minimal sample size required for the valid application of weighted kappa is 2k, where k is the number of categories. This formula ensures that the calculation, confidence intervals, and p-values. Agreement between urine collection techniques was calculated using weighted and Cohens' kappa (k) for ordinal and binary outcomes respectively. The above analysis was repeated and stratified by type of pelvic organ prolapse; namely, anterior, posterior, and apical.
Significant agreement was determined if the kappa was greater than or equal to 0.75, in accordance with Fleiss (1981). The Wilcoxon signed-rank (WSR) test was used as a paired difference test between urine collection techniques. All analysis was conducted in SAS Version 9.2 (Cary, NC: SAS Institute, 2002–2008).