Recruiting
Phase 2

Heparin

Sponsor:

The Christ Hospital

Code:

NCT03633994

Conditions

Lower Urinary Tract Symptoms

Postoperative Urinary Tract Infection

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Heparin

Normal saline

Study Details

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.

Conditions

Lower Urinary Tract Symptoms

Postoperative Urinary Tract Infection

Study ID

NCT03633994

Start date

Aug 20, 2018

Status verified date

Oct, 2019

Completion date

Mar 1, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Lower urinary tract symptoms [ Time Frame: Postoperative day 14 ]

Central Contacts and Locations

Central contacts

Hoi Tik H Yuen, MD

(513) 463-2500hoitik.yuen@thechristhospital.com

James Whiteside, MD

(513) 475-8248

Locations

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Hoi Tik H Yuen, MD

513-463-2500hoitik.yuen@thechristhospital.com

James L Whiteside, MD

whitesje@ucmail.uc.edu

More Information

Sponsor

The Christ Hospital

Last update posted

Oct 10, 2019

Last verified

Oct, 2019

Keywords

  • Randomized controlled trial
  • Heparin instillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Christ Hospital on 2019-10-10.