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Assessment of Potential Biomarkers in Women With Symptoms of Overactive Bladder and Pelvic Organ Prolapse

NCT03516292 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2021-12-13

No results posted yet for this study

Summary

The objective of this study is to investigate the role of certain biomarkers in the initial assessment of women with overactive bladder (OAB). Nerve Growth Factor (NGF) levels, measured in urine samples, and bladder wall thickness (BWT), determined by two-dimensional transvaginal ultrasound, are two of those markers. The investigators hypothesize that the pre-operative determination of these biomarkers in women suffering from genital prolapse and overactive bladder could lead to a more accurate prognosis of the post-operative course of overactive bladder symptoms in women undergoing surgical treatment of prolapse.

Conditions

Interventions

DIAGNOSTIC_TEST

Urinary Nerve Growth Factor

The subjective patient's discomfort regarding the vaginal prolapse problems and urinary incontinency symptoms will be assessed through the following questionnaires: (a) ICIQ-OAB (b) ICIQ FLUTS (c) ICIQ-VS. Determination of the bladder neck of urethra in midsagittal plane using a transvaginal two-dimensional ultrasound machine at lithotomy position in rest (point OA) and on Valsalva maneuver (point OB). Bladder Neck Mobility is defined as the difference from point OA to OB. BWT is determined and measured as the hypoechoic layer between two hyperechoic layers that is recognized as the urothelium and the perivesical tissue using a transvaginal two-dimensional ultrasound machine at lithotomy position. The measurement is performed with a bladder volume \<30 ml and is taken place in 3 different bladder sites: (a) the thickest part of the bladder triangle, (b) the dome of the bladder in the midline, (c) the anterior wall of the bladder. NGF will be measured in urine sample.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Themistoklis Mikos, MD PhD · Aristotle University Of Thessaloniki

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2022-01-30
Completion
2022-12-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516292 on ClinicalTrials.gov