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Hormonal Influences on Diuresis (HODI)

Primary Purpose

Nocturia, Menopause, LUTS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICIQ FLUTS Questionaires
Frequency Volume Chart
Renal Function Profile
Blood Analysis
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hormonal therapy

    Arm Description

    Patients choosing to start hormoanl treatment using ural or transdermal estrogen.

    Outcomes

    Primary Outcome Measures

    Change of HT on nocturnal frequency
    Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.

    Secondary Outcome Measures

    Effect on nocturnal urine production
    Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml)

    Full Information

    First Posted
    May 4, 2021
    Last Updated
    May 17, 2021
    Sponsor
    University Hospital, Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04891926
    Brief Title
    Hormonal Influences on Diuresis
    Acronym
    HODI
    Official Title
    Influence of Hormonale Changes on Diuresis and LUTS in the Gynaecological Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (undefined)
    Primary Completion Date
    September 30, 2018 (Actual)
    Study Completion Date
    September 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Ghent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to observe the effect of hormonal treatment (oral or transdermal substitution therapy) on diuresis (salt and water diuresis) and lower urinary tract symptoms (LUTS) in postmenopausal women

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nocturia, Menopause, LUTS, Diuresis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hormonal therapy
    Arm Type
    Experimental
    Arm Description
    Patients choosing to start hormoanl treatment using ural or transdermal estrogen.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ICIQ FLUTS Questionaires
    Intervention Description
    Questionnaire observing the impact on voiding disfunctions
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Frequency Volume Chart
    Intervention Description
    Frequency Volume Chart measures the voided volumes and fluid intake during 3 days in order to observe patients bladder capacity, total and nighttime voided volume and voiding frequency
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Renal Function Profile
    Intervention Description
    The RFP is a 24-hour urine analysis in which urine samples are collected at fixed time points every 3 hours, starting 3 hours after the first morning void. This RFP was collected on a separated day to the FVC. Daytime samples were taken between 10:00-11:30 (U1), 13:00-15:30 (U2), 16:00-17:30 (U3), 19:00-20:30 (U4), and 22:00-23:30 (U5). The night-time samples were taken between 1:00-2:30 (U6), 4:00-5:30 (U7) and 7:00-8:30 (U8), and the volume of each interim void, was noted to calculate the 24h, daytime and night-time urine volume and diuresis rate. On each of this 8 samples, creatinine, osmolality, sodium and urea concentration were analysed. Subsequently, the renal clearance of creatinine, solutes, sodium and potassium (Usubst x Uflow / Psubst) and FWC (urine flow - solute clearance) were calculated.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Blood Analysis
    Intervention Description
    Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.
    Primary Outcome Measure Information:
    Title
    Change of HT on nocturnal frequency
    Description
    Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Effect on nocturnal urine production
    Description
    Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml)
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Menopausal women
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc) Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35550708
    Citation
    Pauwaert K, Bruneel E, Van Laecke E, Depypere H, Everaert K, Goessaert AS. Does hormonal therapy affect the bladder or the kidney in postmenopausal women with and without nocturnal polyuria: Results of a pilot trial? Maturitas. 2022 Jun;160:61-67. doi: 10.1016/j.maturitas.2022.01.009. Epub 2022 Jan 29.
    Results Reference
    derived

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