GAG Replacement vs URethral DIlAtatioN

Recurrent Urinary Tract Infection Clinical Trial

— GUARDIAN  

Official title:

To Investigate and Compare The Efficacy of Urethral Dilatation Versus Glycosaminoglycan Layer Replacement in The Management Of Women With Recurrent Urinary Tract Infections

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03861260
• Other study ID #: 2018-FAM-99
• Status: Withdrawn
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: October 28, 2019

Study information

• Verified date: September 2021
• Source: Hampshire Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Hampshire Hospitals NHS Foundation Trust	Basingstoke	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Hampshire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of Urinary tract infections in the 12 months following treatment	Number of symptomatic UTI episodes in 12 months following treatment	12 months
Secondary	The time to first urinary tract infection after completion of treatment.	Time (in days) to first symptomatic UTI episode after completion of treatment.	12 month study period
Secondary	The change in the Quality of life (QoL) between the time of treatment and at 3, 6 and 12 months following initiation of treatment.	Following treatment is there any recorded change in the QoL questionnaire (SF-12) score from pre-treatment baseline	3, 6 and 12 months
Secondary	The number of adverse events recorded following treatment during the 12-month study period	A record of the number, recorded in groups by their nature, of adverse events following treatment during the 12 month study.	12 months
Secondary	The change in the Patient Satisfaction at 3, 6 and 12 months following initiation of treatment	Following treatment is there any recorded change in the Patient Satisfaction report from pre-treatment baseline	3, 6 and 12 months
Secondary	The change in female sexual function index (FSFI) questionnaire at 3, 6 and 12 months	Following treatment is there any recorded change in the FSFI questionnaire score (out of 36) from pre-treatment baseline	3, 6 and 12 months
Secondary	The change in Hospital anxiety and depression scale (HADS) questionnaire at 3, 6 and 12 months	Following treatment is there any recorded change in the HADS questionnaire score (out of 21 for anxiety and 21 for depression) from pre-treatment baseline	3, 6 and 12 months