Clinical trial NCT03861260: GAG Replacement vs URethral DIlAtatioN
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Urinary Tract Infection
Lead sponsor: Hampshire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of Urinary tract infections in the 12 months following treatment
timeFrame: 12 months
Secondary outcomes:
measure: The time to first urinary tract infection after completion of treatment.
timeFrame: 12 month study period
measure: The change in the Quality of life (QoL) between the time of treatment and at 3, 6 and 12 months following initiation of treatment.
timeFrame: 3, 6 and 12 months
measure: The number of adverse events recorded following treatment during the 12-month study period
timeFrame: 12 months
measure: The change in the Patient Satisfaction at 3, 6 and 12 months following initiation of treatment
timeFrame: 3, 6 and 12 months
measure: The change in female sexual function index (FSFI) questionnaire at 3, 6 and 12 months
timeFrame: 3, 6 and 12 months
measure: The change in Hospital anxiety and depression scale (HADS) questionnaire at 3, 6 and 12 months
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
state: Hampshire
Study officials:
affiliation: Hampshire Hospitals NHS Foundation Trust
name: Christian Phillips, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References: