Hormonal Influences on Diuresis

NCT ID: NCT04891926

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2018-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Nocturia Menopause LUTS Diuresis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hormonal therapy

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

Group Type EXPERIMENTAL

ICIQ FLUTS Questionaires

Intervention Type DIAGNOSTIC_TEST

Questionnaire observing the impact on voiding disfunctions

Frequency Volume Chart

Intervention Type DIAGNOSTIC_TEST

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

Renal Function Profile

Intervention Type DIAGNOSTIC_TEST

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.

Blood Analysis

Intervention Type DIAGNOSTIC_TEST

Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.

Interventions

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ICIQ FLUTS Questionaires

Questionnaire observing the impact on voiding disfunctions

Intervention Type 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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Blood Analysis

Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 35550708 (View on PubMed)

Other Identifiers

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EC2014/1241

Identifier Type: -

Identifier Source: org_study_id

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