Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-04-30
2019-10-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rigid Cystoscopy and Urethral dilatation
Rigid cystoscopy, performed under General Anaesthetic, followed by intervention of urethral dilatation with Hagar dilators.
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 Glycosaminoglycan Layer replacement
Flexible cystoscopy, under Local Anaesthetic, followed by the intervention, which is 6 installations of Ialuril (a Glycosaminoglycan Layer replacement)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. \- Neurological condition
3. \- Diabetes mellitus
4. \- Pregnancy
5. \- Use of Immunosuppressants
6. \- Symptomatic of UTI at time of treatment
FEMALE
No
Sponsors
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Hampshire Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Christian Phillips, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
Hampshire Hospitals NHS Foundation Trust
Locations
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Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom
Countries
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Other Identifiers
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2018-FAM-99
Identifier Type: -
Identifier Source: org_study_id
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