HODI: Hormonal Influences on Diuresis
Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT04891926
Collaborator
(none)
70
1
41
Study Details
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Influence of Hormonale Changes on Diuresis and LUTS in the Gynaecological Population
Study Start Date
:
May 1, 2015
Actual Primary Completion Date
:
Sep 30, 2018
Actual Study Completion Date
:
Sep 30, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hormonal therapy Patients choosing to start hormoanl treatment using ural or transdermal estrogen. |
Diagnostic Test: ICIQ FLUTS Questionaires
Questionnaire observing the impact on voiding disfunctions
Diagnostic Test: Frequency Volume Chart
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
Diagnostic Test: Renal Function Profile
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.
Diagnostic Test: Blood Analysis
Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.
|
Outcome Measures
Primary Outcome Measures
- Change of HT on nocturnal frequency [6 months]
Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.
Secondary Outcome Measures
- Effect on nocturnal urine production [6 months]
Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml)
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Ghent
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT04891926
Other Study ID Numbers:
- EC2014/1241
First Posted:
May 19, 2021
Last Update Posted:
May 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: