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

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ClinicalTrials.gov Identifier: NCT03516292
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : December 13, 2021
Sponsor:
Information provided by (Responsible Party):
Sofia Tsiapakidou, Aristotle University Of Thessaloniki

Brief 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.

Condition or disease Intervention/treatment
Overactive Bladder Diagnostic Test: Urinary Nerve Growth Factor

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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Potential Biomarkers in the Study of Overactive Bladder in Women
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
OAB-POP group
As an Observational Case-Control Study, the participants will divided in two groups depending whether they suffer from overactive bladder symptoms or not. All participants will have POP.
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.
Other Names:
  • Bladder Wall Thickness
  • Bladder Neck Mobility
  • Clinical Assessment of Subjective Vaginal and Urinary Symptoms

POP only group
As an Observational Case-Control Study, the participants will divided in two groups depending whether they suffer from overactive bladder symptoms or not. All participants will have POP.
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.
Other Names:
  • Bladder Wall Thickness
  • Bladder Neck Mobility
  • Clinical Assessment of Subjective Vaginal and Urinary Symptoms




Primary Outcome Measures :
  1. Urinary NGF as a biomarker for OAB symptoms in women with POP [ Time Frame: Two samples will be taken at the time of recruitment (Month 0) at three months post-operatively (Month 3). ]
    Determination of urinary NGF levels' change as a reliable prognostic factor for the treatment of OAB in women with POP before and after surgical repair

  2. Urinary NGF as a biomarker for OAB symptoms in women with POP [ Time Frame: Two samples will be taken at the time of recruitment (Month 0) and at the 1 years follow up appointment post-operatively (Month 12) ]
    Determination of urinary NGF levels' change as a reliable prognostic factor for the treatment of OAB in women with POP before and after surgical repair.


Secondary Outcome Measures :
  1. BWT as a biomarker for OAB symptoms in women with POP [ Time Frame: Ultrasound will take place before surgery repair (Month 0) at three months post-operatively (Month 3). ]
    Determination of BWT's change as a reliable prognostic factor for the treatment of OAB in women with POP.


Biospecimen Retention:   Samples Without DNA
Urine sample of female patients with POP and POP with OAB


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women that visited outpatients Gynecology Department, 1st Department Obstetrics and Gynecology, Aristotle University of Thessaloniki, General Hospital Papageorgiou of Thessaloniki, complaining for vaginal prolapse and possible concomitant urinary problems.
Criteria

Inclusion Criteria:

  • Adult women that are able to communicate and understand comprehensively Greek Language and present vaginal prolapse problems.

Exclusion Criteria:

  • Male patients as well children will be excluded.
  • Women that have already operated once for pelvic organ prolapse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516292


Contacts
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Contact: Sofia Tsiapakidou, PhDc 6946321158 ext +30 sofiatsiapakidou@gmail.com

Locations
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Greece
Aristotle University of Thessaloniki Recruiting
Thessaloníki, Central Macedonia, Greece, 54124
Contact: Sofia Tsiapakidou    6946321158    sofiatsiapakidou@gmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Study Director: Themistoklis Mikos, MD PhD Aristotle University Of Thessaloniki
Publications:
Cruz F, Heesakkers J, Khullar V, Tubaro A. Bladder Wall Thickness in Overactive Bladder: Does It Have a Role? Eur Urol Suppl. 2009; 8(9):769-71

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Responsible Party: Sofia Tsiapakidou, Principal Investigator, PhD Candidate, Resident Doctor in Obstetrics & Gynecology,, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03516292    
Other Study ID Numbers: 411/29.03.2018
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofia Tsiapakidou, Aristotle University Of Thessaloniki:
overactive bladder
biomarker
nerve growth factor
vaginal prolapse
urinary incontinence
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action