NocturiaHODINCT04891926
Hormonal Influences on Diuresis
A study testing ICIQ FLUTS Questionaires, Frequency Volume Chart and Renal Function Profile in people with Nocturia and Menopause, run by University Hospital, Ghent.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- ICIQ FLUTS Questionaires, Frequency Volume Chart and Renal Function Profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)
Who cannot join
- -
About this study
Official title: Influence of Hormonale Changes on Diuresis and LUTS in the Gynaecological Population
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
- Being tested
- ICIQ FLUTS Questionaires, Frequency Volume Chart, Renal Function Profile, Blood Analysis
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICIQ FLUTS QuestionairesDiagnostic test
Questionnaire observing the impact on voiding disfunctions
Frequency Volume ChartDiagnostic 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 ProfileDiagnostic 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 AnalysisDiagnostic test
Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.
| Study group | Role | What they receive |
|---|---|---|
| Hormonal therapy | Experimental | Patients choosing to start hormoanl treatment using ural or transdermal estrogen. Receives: Diagnostic Test: ICIQ FLUTS Questionaires; Diagnostic Test: Frequency Volume Chart; Diagnostic Test: Renal Function Profile; Diagnostic Test: Blood Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HT on nocturnal frequency
Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.
Measured: 6 months
Secondary outcomes (1)
Effect on nocturnal urine production
Change of the nocturnal urine production by hormonal treatment by the volume of one micturition (+- 200ml)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 May 2015
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891926
- Sponsor's protocol ID
- EC2014/1241
- Acronym
- HODI
- Status last verified
- Apr 2021
- First submitted
- 4 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35550708
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hormonale Changes on Diuresis and LUTS in the Gynaecological Population
- ClinicalTrials.gov ID
- NCT04891926
- Acronym / sponsor ID
- HODI / EC2014/1241
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 May 2015
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormonal therapy | Experimental | Diagnostic Test: ICIQ FLUTS Questionaires, Diagnostic Test: Frequency Volume Chart, Diagnostic Test: Renal Function Profile, Diagnostic Test: Blood AnalysisPatients choosing to start hormoanl treatment using ural or transdermal estrogen. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in a postmenopausal state wo wanted to start treatment for menopausal symptoms (hot flushes etc)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICIQ FLUTS QuestionairesQuestionnaire observing the impact on voiding disfunctions | Diagnostic test | Hormonal therapy |
| Frequency Volume ChartFrequency 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 | Hormonal therapy |
| Renal Function ProfileThe 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 | Hormonal therapy |
| Blood AnalysisBlood analysis in order to observ postmenopausal state, osmolalitity and sodium. | Diagnostic test | Hormonal therapy |
Primary outcome
Change of HT on nocturnal frequency
Time frame: 6 months
Change of nocturnal frequency by 1 nocturnal void after 6 months of hormonal treatment.
1 secondary outcome
Effect on nocturnal urine production
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 35550708Pauwaert 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.
- Individual participant dataSharing planned: Undecided
Related trials for Nocturia
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer
Recruiting
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
Benign Prostatic Hyperplasia
Not yet recruitingPhase 4
How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS)
Nocturia
RecruitingPhase 4
Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH
Nocturia
Recruiting
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Over Active Bladder, Urinary Incontinence (UI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ICIQ FLUTS Questionaires, Frequency Volume Chart and Renal Function Profile in people with Nocturia and Menopause, run by University Hospital, Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HT on nocturnal frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.