Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy

Data Collection

Subject demographics and history information will be obtained from The Christ Hospital
Medical Center's electronic medical record. In addition, preoperative diagnosis,
postoperative diagnosis, procedure performed, total operative time, estimated blood loss,
intraoperative complications, anterior prolapse repair, use of cystoscopy, preoperative
urinalysis, postoperative complications, uterine size, and any urine cultures collected
within the 2 week postoperative period will also obtained from the electronic medical record.

The post-operative lower urinary tract symptoms assessments will be collected, the paper
records will be secured in a locker labeled with the study identification number, which will
then be entered into EXCEL on a password secured database and the paper copy will be disposed
of in the secure destruction station.

Descriptive Analysis

Simple statistics and demographics will be done across the two cohorts. Categorical variables
will be analyzed using Chi-square while continuous variables (e.g. UTISA scores) will be
analyzed using t-test so long as the distribution of the data are normal. Additional analyzes
as appropriate will be done to identify group differences based on patient demographics (e.g.
age, concomitant procedures, surgeon, estrogen use, foley catheter placement, etc).

Data Analysis and Data Monitoring

The UTISA survey and VAS pain scale both result a continuous variable that between the two
cohorts will be compared using a t-Test provided the results distribution is normal.
Antibiotic use or self-reported UTI rates are nominal variables that across the cohorts would
be compared using a X2.

Data analysis will be performed using statistical software (JMP 13.2.0, SAS Institute Inc.,
Cary NC, USA). The data will be assembled into a password protected EXCEL (Microsoft, Redmond
WA, USA) spreadsheet. A separate password protected spreadsheet will link the study ID and
the enrolled patient's MRN. Analysis would be done only on the de-identified data.

Data Storage and Confidentiality

Study data will be managed in a password-protected EXCEL (Microsoft, Redmond WA, USA)
spreadsheet on a password-protected computer. A separate password protected spreadsheet
linking the study ID and MRN will be kept on a separate password-protected secure drive. This
"key" file will be securely destroyed when the data has been fully analyzed. Paper records
including consent will be in a locked research drawer, in the designated locked office. The
investigators will dispose of any paper documents after data has been analyzed using the
CINTAS Secure Destruction Station.

Sample Size

The symptom with the highest sensitivity and specificity to predict a UTI is dysuria. A study
in 2013 demonstrated a 50% reduction in UTIs among heparin treated patients, the
investigators estimated an effect size of 0.6, assuming mean UTISA dysuria scores of 2 and 1
among the untreated and treated cohorts assessed on post-operative day 1. Assuming an α of
0.05 and 80% power, the investigators estimate requiring 45 subjects per study arm totaling
90 patients. Assuming at least 15% attrition in each arm, the investigators estimate needing
to enroll at least 52 patients per study arm to a total of 104 patients.

Plans for recruitment of subjects

No advertisement will be used. The recruitment will take at the time of surgical consent, via
phone after patient is identified at the time of preoperative visit, or on the day of
surgery.

Inclusion Criteria:

- 18 to 85-years old

- scheduled to undergo a benign hysterectomy

Exclusion Criteria:

- non-English speakers

- current use of anticoagulants or thrombolytic agents

- known adverse reaction or hypersensitivity to heparin

- history of or active genitourinary tract cancer (bladder, uterine, cervical, ovarian
or vaginal)

- history of neurogenic bladder

- pelvic irradiation

- chemical cystitis

- pregnancy

- antibiotic use within the past 30 days

- Surgical procedures involving: anterior or posterior colporrhaphy, vaginal mesh
excision, fistula repair, diverticulum repair, urethral reconstruction, planned or
incidental cystotomy