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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03633994|
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Urinary Tract Symptoms Postoperative Urinary Tract Infection||Drug: Heparin Drug: Normal saline||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy: A Randomized Controlled Trial|
|Estimated Study Start Date :||August 20, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||March 1, 2020|
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.
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
- 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)
- Postoperative antibiotic use [ Time Frame: Postoperative day 1 to 14 ]Obtained via phone interview
- Postoperative patient satisfaction [ Time Frame: Postoperative day 14 ]Surgical Satisfaction Questionnaire (SSQ-8) assessment conducted via phone interview
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
|Contact: Hoi Tik H Yuen, MD||(513) email@example.com|
|Contact: James Whiteside, MD||(513) 475-8248|