Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy (HILUTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633994
Recruitment Status : Unknown
Verified October 2019 by Hyde Yuen, The Christ Hospital.
Recruitment status was:  Recruiting
First Posted : August 16, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hyde Yuen, The Christ Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms (LUTS) and urinary tract infection (UTI) symptoms such as urinary frequency, urinary urgency, pain with urination, or difficulty voiding following hysterectomy (surgically removing the uterus). The investigators hypothesize that heparin bladder instillations will reduce LUTS, UTI symptoms, and improve patient satisfaction following hysterectomy.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Postoperative Urinary Tract Infection Drug: Heparin Drug: Normal saline Phase 2

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy: A Randomized Controlled Trial
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 Drug: 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%.
Placebo Comparator: 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.
 Drug: Normal saline
Normal saline bladder instillation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Lower urinary tract symptoms [ Time Frame: Postoperative day 14 ]
    lower urinary tract symptoms such as urgency, frequency, dysuria, and hematuria measured by the Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)


Secondary Outcome Measures :
  1. Postoperative antibiotic use [ Time Frame: Postoperative day 1 to 14 ]
    Obtained via phone interview

  2. Postoperative patient satisfaction [ Time Frame: Postoperative day 14 ]
    Surgical Satisfaction Questionnaire (SSQ-8) assessment conducted via phone interview


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients undergoing benign hysterectomy
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633994


Contacts
Layout table for location contacts
Contact: Hoi Tik H Yuen, MD (513) 463-2500 hoitik.yuen@thechristhospital.com
Contact: James Whiteside, MD (513) 475-8248

Locations
Layout table for location information
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Hoi Tik H Yuen, MD    513-463-2500    hoitik.yuen@thechristhospital.com   
Contact: James L Whiteside, MD       whitesje@ucmail.uc.edu   
Sponsors and Collaborators
The Christ Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Hyde Yuen, Female Pelvic Medicine and Reconstructive Surgery Fellow, The Christ Hospital
ClinicalTrials.gov Identifier: NCT03633994    
Other Study ID Numbers: TCH #18-12
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hyde Yuen, The Christ Hospital:
Randomized controlled trial
Heparin instillation
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Tract Infections
Lower Urinary Tract Symptoms
Infections
Urologic Diseases
Urological Manifestations
 Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action