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Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy

NCT03633994 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-10-10

No results posted yet for this study

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

Interventions

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%.

DRUG

Normal saline

Normal saline bladder instillation

Sponsors & Collaborators

  • The Christ Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2019-12-31
Completion
2020-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633994 on ClinicalTrials.gov