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

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000015943
Enrollment
53
Registered
2020-01-14
Start date
2018-12-03
Completion date
2020-04-24
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Aristotle University of Thessaloniki
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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) .

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026