NCT02034890

Brief Summary

Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

January 10, 2014

Last Update Submit

April 22, 2019

Conditions

Urinary Tract Infection

Keywords

orthotopic neobladderurinary tract infectionintravesical instillationhyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • positive urinary culture

    6 months

Secondary Outcomes (1)

  • urinary tract infection

    6 months

Study Arms (2)

hyaluronic acid

EXPERIMENTAL

intravesical instillation of 40 mg of hyaluronic acid at 6 specific time points: 1,2,3 and 4 weeks postoperatively 2 and 3 months postoperatively

Drug: Hyaluronic Acid

retrospective control patients

NO INTERVENTION

retrospective control patients

Interventions

Hyaluronic AcidDRUG

intravesical instillation of 40 mg of hyaluronic acid in 6 specific time points: 1,2,3 and 4 weeks postoperatively (After radical cystectomy and orthotopic neobladder reconstruction) 2 and 3 months postoperatively

hyaluronic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing radical cystectomy and orthotopic neobladder reconstruction

You may not qualify if:

  • patients \<18 years and unwilling to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department, Rabin Medical Center

Petach Tiqva, 49100, Israel

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Hanan Goldberg, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

July 1, 2015

Primary Completion

March 1, 2017

Last Updated

April 24, 2019

Record last verified: 2016-04

Locations

IL(1)