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Trial registered on ANZCTR

Registration number

ACTRN12620000015943

Ethics application status

Approved

Date submitted

27/08/2019

Date registered

14/01/2020

Date last updated

14/01/2020

Date data sharing statement initially provided

14/01/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

A study of clinical parameters and urinary biomarkers associated with pelvic ischemia in the human.

Scientific title

Comparison of lower urinary tract function and urinary biomarkers in patients with occlusion of the common iliac artery, before and after revascularization and normal population: a case control study.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1237-6576

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

lower urinary tract symptoms

occlusion of the common iliac artery

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Our research programme attempts to elucidate the obscure field of pelvic ischemia by investigating clinical and urinary markers in patients with common iliac artery obstruction. All the patients are surgical candidates for iliac artery revascularization and are separated in 2 groups,
Arm 1-those suffering from Lower urinary tract symptoms and
Arm 2-those solely with obstruction.
Revascularization will be performed in patients already scheduled for restoration of vascular obstruction according to vascular surgeons' indications.
A control group of healthy individuals is also considered.
All participants are examined clinically with the use of validated questionnaires, non-interventional uroflow and ultrasound. Blood tests and examination for molecular biomarkers of ischemia in free-flow urine are performed. Additionally, arm 1- undergoes urodynamic evaluation (UDS)-interventional- at baseline. UDS is performed by placement of a small catheter in the urinary bladder through the urethra and another catheter in the rectum. The urinary bladder if filled with saline and following that the patient is ask to urinate. Bladder pressures are recorded during the whole process. During bladder filling the patient is asked about the urge to void and the urination pattern is also recorded. A patient info sheet will be distributed to all participants and an informed consent will be acquired.The urodymanic studies will be performed by expert personnel of Neuro-urological laboratory of the 2nd Urological Department of Aristotle University of Thessaloniki.The study will take place in the General Hospital of Thessaloniki, Papageorgiou.
All patients (Arm-1 an Arm-2) are followed-up at 6 months after revascularization of common iliac artery obstruction. All participants are reexamined clinically with the use of validated questionnaires, non-interventional uroflow and ultrasound. Molecular biomarkers of ischemia in free-flow urine are performed, as well. Additionally, arm 1 undergoes urodynamic evaluation (UDS)-interventional- at 6 months follow-up.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

All participants in control group are examined clinically with the use of validated questionnaires, non-interventional uroflow and ultrasound. Blood tests and examination for molecular biomarkers of ischemia in free-flow urine are performed.

Control group

Active

Outcomes

Primary outcome [1]

Assessment of Lower urinary tract symptoms with the use of IPSS (International Prostate Symptoms Score) in patients before and after revascularization compared to healthy group.

Timepoint [1]

Baseline and after completion of 6-months follow up

Secondary outcome [1]

Comparison of sexual function changes with the use either of IIEF (International Index of Ererctile Function) questionnaire for men or of FSFI (Female Sexual Function Index) questionnaire for women, in patients with pelvic ischemia before and after revascularization compared to control group.

Timepoint [1]

Baseline and after completion of 6-months follow-up

Secondary outcome [2]

Changes in uroflow parameters of bladder function in patients before and after revascularization. This is a composite outcome since uroflow parameters include Voided volume, Qmax (maximum urine flow) and PVR (Post-void residual) urine. This is a non-invasive examination where the patient urinates in an machine (uroflow meter) and the volume of urine (in ml) per time (in sec) is recorded. Following that the residual urine in the urinary bladder are measured with the use of ultra sound.

Timepoint [2]

Baseline and after completion of 6-months follow-up

Secondary outcome [3]

Changes in urodynamics parameters before and after revascularization. This is a composite outcome, since urodynamic parameters include: 1. MCC (maximum cystomanometric capacity), 2. Pdet (detrusor pressure), 3. PVR (post void residual urine) in UDS, 4. presence of overactivity , 5 altered sensation, 6 presence of incontinence.
All the aforementioned parameters are extracted during a urodynamic evaluation (UDS). UDS is an invasive procedure were the bladder is filled with saline via a small catheter and the bladder pressure is recorded during filling and voiding. The volume of urine per time is also recorded. The post void residual is measure after completion of the study, and the evacuation of bladder before the removal of the catheter.

Timepoint [3]

Baseline and after completion of 6 months follow-up.

Secondary outcome [4]

Comparison of urinary biomarkers in all patients before and after revascularization and also between patients and controls. This is an exploratory outcome based on previous studies in animals.

Timepoint [4]

Baseline and after completion of 6 months follow-up for arm 1 and arm 2.

Secondary outcome [5]

Assessment of Lower urinary tract symptoms with the use of OAB-q (overactive bladder questionnaire) in patients before and after revascularization compared to healthy group.

Timepoint [5]

At baseline and at 6 months follow-up

Eligibility

Key inclusion criteria

1. Patients with pelvic obstructive vascular disease with mild to severe lower urinary tract symptoms (Luts) that are scheduled to be submitted to revascularization.
2. The control group will consist of people without peripheral vascular diseases and do not report Luts (IPSS score < 2 in each question) .

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients that cannot be submitted to revascularization.
2. Patients with a history of operation in lower urinary tract for LUTS or incontinence.
3. Patients with a history of bladder or prostate cancer.
4. Patients with current urinary tract infection.
5. Patients with history of major pelvic operation.
6. Patients with bladder stones.
7. Patients taking medication that affect urination for < 6 months.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Case control

Timing

Both

Statistical methods / analysis

Statistical analysis will include estimation of Cronbach's a for the questionnaires and examination of normality of the results. Following that bivariate analysis using the appropriate parametric and non-parametric test will take place. In detail paired t-test or Wilcoxon signed rank test will be performed in order to compare the results before and after revascularization. Spearman or Pearson test will be used in order to examine the correlation of clinical data with urinary biomarkers. Multivariate analysis will also be performed with IPSS score as an independent variable. Subgroup analysis will be performed when possible for further evaluation of the results
According to a previous similar study, a statistically significant change in IPSS score was noted after 6 months follow-up. In detail IPSS score reduction >4 was recorded in patients that underwent revascularization for iliac artery obstruction. Mean value for IPSS and IPSS-QoL was 13.7±8.4 and 3.3±1.0 initially while in 6 months it dropped at 8.1±6.9 (p<0.001) and 2.1±1.1 (p<0.001) respectively. In a study examining gender stratified normative values of IPSS, participants between 60-64 years old scored 7.16±6.73 while those between 65-69 years old scored 7.3±7.15. In order to achieve comparable results in our study, sample size was estimated at 60 participants (30 patients --arm 1 and 2- and 30 healthy individuals-control group). Doing so will allow comparisons before and after intervention in patients (both arm 1 and 2 ) and also controlling the results with normal population. The estimated power of the study will surpass 80%. Additionally, approximately 20% of the participants will possibly drop-out during the study. In order to overcome this advert event without lose in power of the study the total number of participants rises to 72 (N=36 in each group).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

3/12/2018

Date of last participant enrolment

Anticipated

24/04/2020

Actual

Date of last data collection

Anticipated

24/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Greece

State/province [1]

Thessaloniki

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Astellas Pharma AEBE

Address [1]

Agisilaou 6-8.
Marousi, Athens
postal code 15123

Country [1]

Greece

Primary sponsor type

University

Name

Aristotle University of Thessaloniki

Address

Aristotle University of Thessaloniki
University Campus
Postal Code 54124. Thessaloniki

Country

Greece

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Committee of Bioethics and Ethics of The Faculty of Health Sciences (FHS) of Aristotle University of Thessaloniki (AUTH)

Ethics committee address [1]

Aristotle University of Thessaloniki
University Campus
54124 Thessaloniki

Ethics committee country [1]

Greece

Date submitted for ethics approval [1]

Approval date [1]

21/11/2018

Ethics approval number [1]

1/21.11.2018

Summary

Brief summary

Pelvic ischemia is a rising entity in urology, with current knowledge remaining fundamental and studies on human population scarce. Our research programme attempts to elucidate the obscure field of pelvic ischemia by investigating clinical and urinary markers in patients with common iliac artery obstruction. All the patients are candidates for iliac artery revascularization and are separated in 2 groups, those suffering from LUTS and those solely with obstruction. A control group of young healthy individuals is also considered. All participants are examined clinically and urinary markers of pelvic ischemia, that are already analysed in animal models, are measured. Additionally, the group of patients with common iliac obstruction and LUTS undergo urodynamic evaluation and re-evaluated post-surgery. This study aspires to set light on lower urinary tract function of patients with iliac artery obstruction and pelvic ischemia in comparison with healthy individuals. Another target of the research is to investigate probable urinary markers of pelvic ischemia in humans and their association with LUTS. The last aim of the study is to examine iliac artery revascularization as a possible treatment of patients with LUTS and pelvic ischemia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Efstathios Papaefstathiou

Address

Aristotle University of Thessaloniki, 2nd Urological Department. GH of Thessaloniki Papageorgiou. Ring Road, Postal code 56403. Pavlos Melas, Thessaloniki

Country

Greece

Phone

+306937721077

Fax

[email protected]

Contact person for public queries

Name

Dr Efstathios Papaefstathiou

Address

Aristotle University of Thessaloniki, 2nd Urological Department. GH of Thessaloniki Papageorgiou. Ring Road, Postal code 56403. Pavlos Melas, Thessaloniki

Country

Greece

Phone

+306937721077

Fax

[email protected]

Contact person for scientific queries

Name

Dr Efstathios Papaefstathiou

Address

Aristotle University of Thessaloniki, 2nd Urological Department. GH of Thessaloniki Papageorgiou. Ring Road, Postal code 56403. Pavlos Melas, Thessaloniki

Country

Greece

Phone

+306937721077

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

all of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

No end date, available following publication

Available to whom?

Anyone who wishes to access it

Available for what types of analyses?

any purpose

How or where can data be obtained?

access subject to approvals by Principal Investigator - [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4089	Ethical approval			[email protected]
4090	Informed consent form			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Role of Pelvic Ischemia in Human Lower Urinary Tract Symptoms and Sexual Function Among Patients With Common Iliac Artery Obstruction Undergoing Revascularization Surgery	2023	https://doi.org/10.5213/inj.2346028.014

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically