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GAG Replacement vs URethral DIlAtatioN

NCT03861260 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-27

No results posted yet for this study

Summary

The aim of this randomised parallel trial is to compare the efficacy of Glycosaminoglycan layer replacement against cystoscopy and urethral dilatation in the treatment of recurrent urinary tract infection in pre-menopausal women.

The women will be randomised to 1 of 2 arms.Arm 1 patients will receive standard treatment from the Urologists. This will involve rigid cystoscopy and urethral dilatation, under general anaesthetic.

Arm 2 patients will receive standard treatment from the Gynaecologists.

Conditions

  • Recurrent Urinary Tract Infection

Interventions

PROCEDURE

Rigid cystoscopy with urethral dilatation

Patients will have a general anaesthetic and a rigid cytoscopic examination of the bladder dilated with sterile water. The urethra will be dilated from FR20 in incremental diameter increases of 2 to French 32 if possible.

PROCEDURE

Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)

Patients will undergo flexible cystoscopy and intravesical installations of Hyaluronic acid (HA) + Chondroitin Sulphate (CS) (GAGs) weekly for 4 weeks and then at 8 weeks and 12 weeks.

Sponsors & Collaborators

  • Hampshire Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Christian Phillips, MBBS MD · Hampshire Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2019-10-28
Completion
2019-10-28

Countries

  • United Kingdom

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 NCT03861260 on ClinicalTrials.gov