Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy
NCT ID: NCT03633994
Last Updated: 2019-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
104 participants
INTERVENTIONAL
2018-08-20
2020-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Heparin Bladder Instillation
At the completion of the scheduled benign hysterectomy, intravesicular bladder instillation containing 40,000U of heparin (40mL of 10,000U heparin/10mL) will be administered be introduced in a retrograde fashion by gravity via Foley catheter. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening.
Heparin
Heparin is a readily available glycosaminoglycan (GAG) chemically similar to hyaluronic acid and chondroitin sulfate that is currently used to treat chronic painful bladder or interstitial cystitis. Heparin intravesical treatment is an inexpensive second-line treatment for chronic painful bladder, characterized by urinary frequency, urgency and pain. Heparin has been shown to re-establish the bladder urothelial GAG layer and as already noted was shown to reduce recurrent urinary tract infections by 50%.
Normal Saline Bladder Instillation
Patients randomized to the control group will undergo intravesical instillation with 40mL of normal saline. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening.
Normal saline
Normal saline bladder instillation
Interventions
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Heparin
Heparin is a readily available glycosaminoglycan (GAG) chemically similar to hyaluronic acid and chondroitin sulfate that is currently used to treat chronic painful bladder or interstitial cystitis. Heparin intravesical treatment is an inexpensive second-line treatment for chronic painful bladder, characterized by urinary frequency, urgency and pain. Heparin has been shown to re-establish the bladder urothelial GAG layer and as already noted was shown to reduce recurrent urinary tract infections by 50%.
Normal saline
Normal saline bladder instillation
Eligibility Criteria
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Inclusion Criteria
* scheduled to undergo a benign hysterectomy
Exclusion Criteria
* 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
18 Years
85 Years
FEMALE
No
Sponsors
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The Christ Hospital
OTHER
Responsible Party
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Hyde Yuen
Female Pelvic Medicine and Reconstructive Surgery Fellow
Locations
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The Christ Hospital
Cincinnati, Ohio, United States
Countries
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Central Contacts
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James Whiteside, MD
Role: CONTACT
Facility Contacts
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References
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Other Identifiers
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TCH #18-12
Identifier Type: -
Identifier Source: org_study_id
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