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Trial record 3 of 8 for:    ialuril

Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis (HATPIN)

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ClinicalTrials.gov Identifier: NCT03981458
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
The Urology Foundation, UK
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:

In post-menopausal women, the condition atrophic vaginitis results from the loss of oestrogen and is characterised by dyspareunia (pain during intercourse), vaginal dryness, and vaginal irritation. It is often diagnosed alongside recurrent urinary tract infections (rUTIs) and may increase susceptibility to rUTI. Topical vaginal oestrogen can be used to re-condition the vaginal epithelium and also reduces the incidence of rUTIs. However, patients often express concerns about using oestrogen, a hormonal treatment. Studies also report side-effects including vaginal bleeding, discharge, burning and itching that underpin significant (28%) drop-out rates. Hence, alternative non-hormonal, non-antibiotic based therapies that treat the vaginal atrophy, but also reduce the incidence of rUTI are needed.

Recurrent UTI in adult women is common. Bacteria from the gut can colonise the vulvar epithelia and then the bladder, causing uncomfortable urinary symptoms (cystitis). The lifetime risk of a UTI is around 40% in adult women which increases in post-menopausal women. Annually, UTI incidence is 3%. Of those affected, 5% will suffer rUTI, rising to 13% in the over 60 population. This equates to over 300,000 of the adult female UK population annually affected by rUTI. The most frequent treatment for rUTIs is low dose antibiotics, but this treatment causes the bacteria carried by such women to become antibiotic resistant, which exacerbates the clinical problem. The prevalence of antimicrobial multi-resistance within post-menopausal women suffering from rUTI is around 25% and was shown to rise to more than 80% following prolonged antibiotics. These data support the use of non-antibiotic treatment strategies that prevent rUTI and the emergence of drug resistant micro-organisms.

This study will compare two groups with differing treatment strategies. One group will be primarily treated for atrophic vaginitis with topical vaginal hyaluronate and the other will be primarily treated for their recurrent UTI with intravesical hyaluronate.


Condition or disease Intervention/treatment Phase
Atrophic Vaginitis Urinary Tract Infections Device: Hyalofemme Device: Ialuril Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Atrophic vaginitis and recurrent urinary tract infection are often found concurrently in post-menopausal women. The argument over which condition appeared first, or if one is caused by the other, is prevalent in clinical settings and there is no official guidance as to which should be treated first. We propose two arms to this study - one treating the atrophic vaginitis via use of Hyalofemme cream (hyaluronate cream), and the other treating recurrent UTI by use of Ialuril (hyaluronate bladder instillation). We intend to investigate the effect on the incidence of UTI in the patients with both treatments, as well as focusing on some markers of the immune response in the urine and vaginal douche samples from these participants.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hyalofemme
Hyalofemme is a cream/gel containing hyaluronic acid, designed to be applied vaginally. This is primarily used in treatment of atrophic vaginitis and is applied by the patient once every three days. We intend treatment to continue for 6 months.
Device: Hyalofemme
Gel made with hyaluronic acid to be applied vaginally to treat atrophic vaginitis.
Other Names:
  • Hyaluronic acid gel
  • Hyaluronate gel

Active Comparator: Ialuril
Ialuril is a bladder instillation designed to be delivered to the bladder via catheter. This is primarily used in patients suffering from recurrent UTI and acts to help rebuild the lining of the bladder, reducing irritation. Ialuril is applied weekly for 6 weeks, followed by every 2 weeks for 6 weeks, then once monthly for maintenance. Treatment will be continued for 6 months.
Device: Ialuril
Bladder instillation of hyaluronic acid to treat recurrent UTI.
Other Names:
  • Hyaluronic acid instillation
  • Hyaluronate instillation




Primary Outcome Measures :
  1. Reduced incidence of medically confirmed urinary tract infection [ Time Frame: Number of UTIs will be assessed at both 6 months (end of treatment) and 9 months (end of follow-up period) ]
    Occurrence of symptomatic UTI with prescription and taking of a treatment course of antibiotics for UTI. Applicable for both treatment arms in comparison to baseline established in the previous 12 months.


Secondary Outcome Measures :
  1. Number of microbiologically-proven UTIs [ Time Frame: 6 and 9 months ]
    Occurrence of symptomatic UTI and the demonstration of a positive urine culture, rather than UTI symptoms potentially caused by interstitial cystitis without bacterial infection.

  2. Effect on vaginal atrophy [ Time Frame: 3, 6 and 9 months ]

    The two treatment arms will be compared to baseline to discover whether any improvement in vaginal atrophy symptoms are seen with either treatment. This will be assessed via questionnaires to determine symptoms experienced and their severity at 0 (baseline), 3, 6 and 9 months. Symptoms that participants will be asked to assess are as follows:

    • Frequency of urination
    • Urgency of urination
    • Pain or burning during urination
    • Partial bladder emptying
    • Fever or shivers
    • Pain in the lower abdomen or pelvis
    • Lower back pain
    • Blood in the urine Participants will rank the severity of these symptoms from "Did not have" to "Severe", and how troublesome they were from "Not at all" to "A lot" by marking a line to indicate where the participant feels their symptoms lie. Upon analysis of the questionnaires, placement of this mark will be measured and used to determine differences in symptoms from baseline throughout the study.

  3. Uropathogen identification [ Time Frame: 9 months ]
    Urine samples will be analysed for the presence of bacteria. If any are found they will be cultured, identified and potentially undergo molecular typing to discover whether particular strains are more prevalent in patients suffering from concurrent rUTI and atrophic vaginitis.

  4. Innate immune response in urine and vaginal douche samples measured by ELISA for cytokines and antimicrobial peptides (e.g. interleukin-8, beta-defensin 2). [ Time Frame: 9 months ]
    Urine and vaginal douche samples will be collected at baseline and at 3-monthly intervals. These will be analysed by ELISA for the presence of innate immune markers and cytokines, such as defensins, interleukin-8 and lipocalin. A potential change in expression may indicate that this is partly how the treatments help to prevent against UTI.

  5. Analysis of polymorphisms in receptor proteins known to be involved in UTI [ Time Frame: 9 months ]
    Patient blood samples will be collected at baseline and DNA extracted. These will be examined for SNPs in genes such as TLR5, which encodes a receptor protein known to affect patient response to bacteria in cases of UTI.

  6. Participant quality of life - does either treatment increase overall quality of life by decreasing symptoms from UTI and/or atrophy? [ Time Frame: 3, 6 and 9 months ]
    Participants will be asked to complete questionnaires (EQ-5D) pertaining to their overall health and quality of life at baseline and at 3-monthly intervals to determine whether treatments are improving their overall health and general wellbeing at 0, 3, 6 and 9 months. This is a validated questionnaire commonly used in healthcare to determine general health and includes assessments of mobility, self-care, ability to carry out normal activity, pain/discomfort levels and anxiety/depression. This also asks participants to assess their overall health state by marking on a scale from 0-100, with higher numbers representing the best imaginable state of health.

  7. Reduction in antibiotic use for UTI as a result of hyaluronate treatment by either route of administration [ Time Frame: Results will be analysed at both end of treatment (6 months) and end of follow-up (9 months) ]
    Incidences of antibiotic use, in general and specifically for UTI, will be recorded to observe whether the treatments result in fewer courses of antibiotics being prescribed.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Postmenopausal women not receiving hormonal supplementation.

    • Women with atrophic vaginitis and rUTI who, in consultation with a clinician, have decided that either hyaluronate treatment (intravesical or vaginal) is an appropriate option.
    • Women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last 6 months.
    • Able to attend a urology clinic for catheterisation on a regular basis (initially weekly) to initiate intravesical bladder instillation treatment.
    • Able to apply vaginal hyaluronate gel at home every 3 days.
    • Able to give informed consent for participation in study.
    • Able and willing to adhere to a 9-month study period.

Exclusion Criteria:

  • • Postmenopausal women receiving hormonal supplementation (e.g. HRT or oestrogen creams).

    • Women unable to use hyaluronate e.g. due to previous sensitivity issues.
    • Women with urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI.
    • Presence of symptomatic UTI - this will be treated and symptoms resolved prior to randomisation.
    • Women currently using hyaluronate for either treatment of atrophic vaginitis or prevention of recurrent UTI or women who have used either study treatment in the preceding 12 months.
    • Women receiving prophylactic antibiotics.
    • Catheter usage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981458


Contacts
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Contact: Christopher Harding, MD 0191 2337321 chris.harding@nuth.nhs.uk
Contact: Judith Hall, PhD 0191 2088346 judith.hall@ncl.ac.uk

Locations
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United Kingdom
Freeman Hospital Recruiting
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Contact: Christopher Harding, MA MB BChir MD    0191 233 6161 ext 37597    chris.harding@nuth.nhs.uk   
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
The Urology Foundation, UK
Investigators
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Principal Investigator: Christopher Harding, MD Newcastle-upon-Tyne Hospitals NHS Trust

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03981458     History of Changes
Other Study ID Numbers: HATPIN
8904 ( Other Identifier: R&D Number Newcastle Hospitals )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Vaginitis
Atrophic Vaginitis
Atrophy
Urologic Diseases
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents