Recurrent Urinary Tract InfectionGUARDIANNCT03861260
GAG Replacement vs URethral DIlAtatioN
A study testing Rigid cystoscopy with urethral dilatation and Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril) in people with Recurrent Urinary Tract Infection, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Rigid cystoscopy with urethral dilatation and Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2019to 28 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Pre-menopausal 3 - 3 episodes of cystitis in the last 12 months as defined by:
- 3 symptoms from dysuria, frequency, urgency, suprapubic tenderness, haematuria, polyuria
- 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
Who cannot join
- - Anatomical anomalies of urinary tract
- - Neurological condition
- - Diabetes mellitus
- - Pregnancy
- - Use of Immunosuppressants
- - Symptomatic of UTI at time of treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, RG24 9NA
About this study
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
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.
Read the 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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Rigid cystoscopy with urethral dilatation, Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid cystoscopy with urethral dilatationProcedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Rigid Cystoscopy and Urethral dilatation | Other | Rigid cystoscopy, performed under General Anaesthetic, followed by intervention of urethral dilatation with Hagar dilators. Receives: Procedure: Rigid cystoscopy with urethral dilatation |
| Flexible cystoscopy and Glycosaminoglycan Layer replacement | Other | Flexible cystoscopy, under Local Anaesthetic, followed by the intervention, which is 6 installations of Ialuril (a Glycosaminoglycan Layer replacement) Receives: Procedure: Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Urinary tract infections in the 12 months following treatment
Number of symptomatic UTI episodes in 12 months following treatment
Measured: 12 months
Secondary outcomes (6)
The time to first urinary tract infection after completion of treatment.
Time (in days) to first symptomatic UTI episode after completion of treatment.
Measured: 12 month study period
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
Measured: 3, 6 and 12 months
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.
Measured: 12 months
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
Measured: 3, 6 and 12 months
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
Measured: 3, 6 and 12 months
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
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start30 Apr 2019
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Why it stopped: Withdrawn no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hampshire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Phillips, MBBS MD, Principal investigator, Hampshire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861260
- Sponsor's protocol ID
- 2018-FAM-99
- Acronym
- GUARDIAN
- Status last verified
- Sep 2021
- First submitted
- 3 May 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03861260
- Acronym / sponsor ID
- GUARDIAN / 2018-FAM-99
- Conditions
- Recurrent Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hampshire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigid Cystoscopy and Urethral dilatation | Other | Procedure: Rigid cystoscopy with urethral dilatationRigid cystoscopy, performed under General Anaesthetic, followed by intervention of urethral dilatation with Hagar dilators. |
| Flexible cystoscopy and Glycosaminoglycan Layer replacement | Other | Procedure: Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)Flexible cystoscopy, under Local Anaesthetic, followed by the intervention, which is 6 installations of Ialuril (a Glycosaminoglycan Layer replacement) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Pre-menopausal 3 - 3 episodes of cystitis in the last 12 months as defined by:
Key exclusion criteria (6 listed)
- - Anatomical anomalies of urinary tract
- - Neurological condition
- - Diabetes mellitus
- - Pregnancy
- - Use of Immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rigid cystoscopy with urethral dilatationPatients 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 or surgery | Rigid Cystoscopy and Urethral dilatation |
| 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. | Procedure or surgery | Flexible cystoscopy and Glycosaminoglycan Layer replacement |
Primary outcome
The number of Urinary tract infections in the 12 months following treatment
Time frame: 12 months
Number of symptomatic UTI episodes in 12 months following treatment
6 secondary outcomes
The time to first urinary tract infection after completion of treatment.
Time frame: 12 month study period
The change in the Quality of life (QoL) between the time of treatment and at 3, 6 and 12 months following initiation of treatment.
Time frame: 3, 6 and 12 months
The number of adverse events recorded following treatment during the 12-month study period
Time frame: 12 months
The change in the Patient Satisfaction at 3, 6 and 12 months following initiation of treatment
Time frame: 3, 6 and 12 months
The change in female sexual function index (FSFI) questionnaire at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The change in Hospital anxiety and depression scale (HADS) questionnaire at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
Related trials for Recurrent Urinary Tract Infection
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Recurrent Urinary Tract Infection
RecruitingPhase 1
Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
Recurrent UTIs, Cystitis Recurrent
Active, not recruitingPhase 4
Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
Recurrent Urinary Tract Infection, Hypoestrogenism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Phillips, MBBS MD principal investigator
Hampshire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid cystoscopy with urethral dilatation and Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril) in people with Recurrent Urinary Tract Infection, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of Urinary tract infections in the 12 months following treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.