Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study

NCT02023502 | Completed

• 1 other identifier: EK 1788/2013
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The primary objective of the study is the comparison of protein concentrations between patients with stress urinary incontinence (SUI) and healthy controls. Aim: This pilot study aims to determine a possible altered protein profile in women suffering from SUI, compared to healthy women and therefore to discriminate a potential protein biomarker for SUI. Main outcome measure: mass spectrometric measuring of urinary proteomic secretome in diseased and healthy subjects (sequence coverage and number of identified proteins) Trial design: Prospective case- control study Setting: Department of Gynecology and Obstetrics of the Medical University of Vienna in co- operation with the Core Facilities Proteomics of the Medical University of Vienna Population: Twenty female patients with SUI and twenty healthy patients who attend the outpatient clinic of the Department of Obstetrics and Gynaecology, Medical University of Vienna (sample size calculation FDR 0.05, power of 80%, assumed proportion of true H0 0.95, assumed standardized effect size of 1) Methods: Examinations to be carried out: patient history, provocative stress test, ICIQ short form questionnaire, residual urine volume (ultrasound) and urine analysis (dipstick testing). A urine sample is obtained from the patient after spontaneous micturition, to which protease inhibitor will be added immediately. Two serum blood vials (each 9ml) are taken from a peripheral vein of the patient for routine laboratory and further research. Proteomics analysis will be performed using chromatographic separation (LC) with mass spectrometric detection (MS).

Conditions

Female Stress Urinary Incontinence

Keywords

female stress urinary incontinence; proteomics; biomarker

Outcome Measures

Primary Outcomes (1)

• mass spectrometric measuring of urinary proteomic secretome in diseased and healthy subjects (sequence coverage and number of identified proteins)

  Comparison of protein concentrations based on number of identified proteins and mass spectrometric spectral count for patients with stress urinary incontinence and healthy controls.

  The primary outcome measure will be assessed for each participant in a time frame of 4-7 days after recruitment

Study Arms (2)

stress urinary incontinence

Patients presenting with stress urinary incontinence according to the inclusion and exclusion criteria

Other: collection of urine and blood sample

healthy controls

healthy women with the same inclusion and exclusion criteria as the case group, except for stress urinary incontinence

Other: collection of urine and blood sample

Interventions

collection of urine and blood sample OTHER

healthy controls; stress urinary incontinence

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the urogynaecology and general gynecology outpatient clinic of the Department of Obstetrics and Gynaecology at the Medical University of Vienna

You may qualify if:

• patients with stress urinary incontinence: a history of symptoms of stress urinary incontinence for at least 3 months (including anamnestic complaints of involuntary leakage on effort or exertion or on sneezing or coughing) and a positive provocative stress test (defined as an observed transurethral loss of urine that was simultaneous with a cough or Valsalva maneuver at a bladder volume of 300ml or less)
• patients capable of independent toiling
• patients who are able to fully understand all study procedures and to provide written informed consent to study participation
• age ≥ 18
• patients after vaginal delivery

You may not qualify if:

• patients who have previously been treated for SUI (both surgical or pharmacological treatment)
• patients who have a medical history of uncontrolled overactive bladder (OAB) or urinary incontinence other than SUI (including anamnestic complaints on involuntary urine leakage accompanied by or immediately preceded by urgency, not stress induced)
• patients with well established neurological disorder (e.g. Multiple Sclerosis, Parkinson's disease, Alzheimer's disease)
• patients with pelvic organ prolapse stage ≥ II (ICS classification)
• patients with a clinically significant bladder outlet obstruction and/or patients with a post void residual volume (PVR) \> 100ml
• patients with a history of acute urinary retention or history of repeated catheterizations due to acute urinary retention within the last 3 months prior to the day of informed consent
• patients with an indwelling catheter and patients practicing intermittent self- catheterization
• patients who have undergone a bladder biopsy or any other minor pelvic surgical intervention less than 30 days prior to the day of informed consent
• patients with a history of bladder cancer
• patients with acute or recurrent urinary tract infection and/or unexplained haematuria
• patients with stone(s) in the bladder or urethra and upper tract stone disease causing symptoms
• patients with evidence of renal insufficiency (creatinine \> 1.5x upper limit of normal)
• patients with evidence of hepatic disease (total bilirubin \>1.5x upper limit of normal, or AST or ALT or alkaline phosphatase \>2x upper limit of normal)
• patients with a history of alcohol and/or other drug abuse
• patients who are unable and/or unlikely to comprehend and follow the study procedures and instructions

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Obstetrics and Gynaecology

Vienna, 1090, Austria

Location

Related Publications (7)

• Mushkat Y, Bukovsky I, Langer R. Female urinary stress incontinence--does it have familial prevalence? Am J Obstet Gynecol. 1996 Feb;174(2):617-9. doi: 10.1016/s0002-9378(96)70437-4.

  PMID: 8623794 BACKGROUND

• Elia G, Bergman J, Dye TD. Familial incidence of urinary incontinence. Am J Obstet Gynecol. 2002 Jul;187(1):53-5. doi: 10.1067/mob.2002.124842.

  PMID: 12114888 BACKGROUND

• Chen B, Wen Y, Zhang Z, Guo Y, Warrington JA, Polan ML. Microarray analysis of differentially expressed genes in vaginal tissues from women with stress urinary incontinence compared with asymptomatic women. Hum Reprod. 2006 Jan;21(1):22-9. doi: 10.1093/humrep/dei276. Epub 2005 Aug 26.

  PMID: 16126751 BACKGROUND

• Hu S, Loo JA, Wong DT. Human body fluid proteome analysis. Proteomics. 2006 Dec;6(23):6326-53. doi: 10.1002/pmic.200600284.

  PMID: 17083142 BACKGROUND

• Ho L, Sharma N, Blackman L, Festa E, Reddy G, Pasinetti GM. From proteomics to biomarker discovery in Alzheimer's disease. Brain Res Brain Res Rev. 2005 Apr;48(2):360-9. doi: 10.1016/j.brainresrev.2004.12.025.

  PMID: 15850675 BACKGROUND

• Semmes OJ, Feng Z, Adam BL, Banez LL, Bigbee WL, Campos D, Cazares LH, Chan DW, Grizzle WE, Izbicka E, Kagan J, Malik G, McLerran D, Moul JW, Partin A, Prasanna P, Rosenzweig J, Sokoll LJ, Srivastava S, Srivastava S, Thompson I, Welsh MJ, White N, Winget M, Yasui Y, Zhang Z, Zhu L. Evaluation of serum protein profiling by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for the detection of prostate cancer: I. Assessment of platform reproducibility. Clin Chem. 2005 Jan;51(1):102-12. doi: 10.1373/clinchem.2004.038950.

  PMID: 15613711 BACKGROUND

• Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro VA, Steinberg SM, Mills GB, Simone C, Fishman DA, Kohn EC, Liotta LA. Use of proteomic patterns in serum to identify ovarian cancer. Lancet. 2002 Feb 16;359(9306):572-7. doi: 10.1016/S0140-6736(02)07746-2.

  PMID: 11867112 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Heinz Kölbl, Univ.-Prof.Dr.Dr.h.c.

  Medical University of Vienna, Department of Obstetrics and Gynaecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 30, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

AU (1)