Back to resultsHormonal 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
About this trial
This is an interventional treatment trial for Nocturia
Eligibility Criteria
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
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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Hormonal Influences on Diuresis
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