GAG Replacement vs URethral DIlAtatioN (GUARDIAN)

National Health Service (NHS)

Status: Withdrawn

Conditions: Recurrent Urinary Tract Infection

Treatments: Procedure: Rigid cystoscopy with urethral dilatation; Procedure: Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)

Study type: Interventional

Funder types: Other

Identifiers

NCT03861260

2018-FAM-99

Details and patient eligibility

About

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.

Full description

Recurrence of a Urinary Tract Infection (UTI) is defined as infection, following complete resolution of a previous UTI.Recurrent UTI (rUTI) is defined as 3 or more microbiologically confirmed UTI within 12 months. rUTI is an economic problem for healthcare services. rUTI is also detrimental to the quality of life (QoL) of women who suffer the disease. 61% of women who suffer rUTI report symptoms of depression and an associated decrease in their reported QoL scores. QoL was found to improve significantly with successful treatment.

E-coli is the most common bacteria causing UTI and 10% are thought to be antibiotic resistant. Consequently, new treatment strategies are required.

The Glycosaminoglycans (GAG) layer is thought to be instrumental as a defence mechanism against uro-pathogens.

GAG's are polysaccharides forming a gel like substance on the apical surface of the bladder wall and act as a barrier to uro-pathogens. There is now strong evidence that a reduction in the impermeability of the GAG layer is linked to rUTI. Urethral dilatation is an alternative treatment to GAG replacement in the management of rUTI. It is a treatment option more widely adopted by Urologists, although there is a paucity of data to support its use.

Currently there is no standardised strategy for the management of women with rUTI. Treatments vary between GAG layer replacement (intravessical therapy with hyaluronic acid and chondroitin sulphate) or a cystoscopy and urethral dilatation. Evidence for each regime varies greatly and is of poor quality. This is a randomised study comparing GAG layer replacement with cystoscopy and urethral dilatation.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female

2. Pre-menopausal 3 - 3 episodes of cystitis in the last 12 months as defined by:

   1. 3 symptoms from dysuria, frequency, urgency, suprapubic tenderness, haematuria, polyuria
   2. Or less than 2 symptoms from the above list, but with cloudy urine 4 - Normal flow studies with bladder residual <150ml 5 - Normal renal tract on USS

Exclusion criteria

1. • Anatomical anomalies of urinary tract
2. • Neurological condition
3. • Diabetes mellitus
4. • Pregnancy
5. • Use of Immunosuppressants
6. • Symptomatic of UTI at time of treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Rigid Cystoscopy and Urethral dilatation

Other group

Description:

Rigid cystoscopy, performed under General Anaesthetic, followed by intervention of urethral dilatation with Hagar dilators.

Treatment:

Procedure: Rigid cystoscopy with urethral dilatation

Flexible cystoscopy and Glycosaminoglycan Layer replacement

Other group

Description:

Flexible cystoscopy, under Local Anaesthetic, followed by the intervention, which is 6 installations of Ialuril (a Glycosaminoglycan Layer replacement)

Treatment:

Procedure: Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)