Female Stress Urinary IncontinenceNCT02023502
Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study
An observational study of Female Stress Urinary Incontinence, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- collection of urine and blood sample
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- patients who are pregnant or lactating
- patients with serious medical conditions who, in the opinion of the investigators, should not participate in this study
- The control group is represented by patients with the same inclusion and exclusion criteria as the case group, except stress urinary incontinence.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Obstetrics and Gynaecology
Vienna, 1090
About this study
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.
Read more
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).
Read the detailed description
Methods:
Sample preparation and analysis will include:
- Sample collection and immediate addition of protease inhibitor cocktail (Roche, Complete Protease Inhibitor Cocktail).
- Urine centrifugation and filtration for removal of cell debris.
- Protein precipitation by applying methanol/chloroform separation for removal of all possible non-proteinic substances.
- Protein digestion applying in-solution trypsin, pepsin, and Glu-C.
- Peptide separation using nano HPLC and different chromatographic approaches.
- Reversed phase (RP) separation of peptides and MS detection
- Separation of peptides using HILIC (hydrophilic Interaction Liquid Chromatography) for discrimination of polar peptides.
- In addition to RP and HILIC directly coupled to MS, digested peptides will be separated using multidimensional approaches. Weak anion exchange columns operated under HILIC conditions will be used to separate peptides carrying posttranslational modifications such as phosphorylation or acetylation, thus, increasing the dynamic range of detection. During this separation, fractions will be collected and re-injected onto the RP and HILIC with MS detection.
- All nano HPLC separations will be performed using biocompatible separation system.
Mass spectrometric analysis of digested peptides will be performed using two different detection methods: ion-trap and the time-of-flight (qToF) MS. qToF mass spectrometric detection and analysis will also be used for the label-free quantitation of peptides and proteins detected in samples. All measurements will be performed in triplicate to provide corrections for technical variability of separation and ionization.
General database search will be performed using the Human SwissProt Database in its actual version at the time of analysis. Data search will be performed using Mascot (http://www.matrixscience.com/) and X!Tandem (http://www.thegpm.org/tandem/) search machines, and the final data allocation and filtering by using Scaffold (www.proteomsoftware.com).
Statistical analysis:
Data analysis will be conducted with the bioconductor package limma. Before data analysis, data will be filtered by excluding proteins with measurements with a low interquartile range. Groups will be compared by moderated paired t-statistics adjusting for age. Adjustment for multiple testing will be done by Benjamini-Hochberg correction controlling the FDR at 0.05.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- collection of urine and blood sample
- Keywords
- female stress urinary incontinence, proteomics, biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of urine and blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| stress urinary incontinence | Patients presenting with stress urinary incontinence according to the inclusion and exclusion criteria Receives: 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 Receives: Other: collection of urine and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome measure will be assessed for each participant in a time frame of 4-7 days after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Koch, Medical University of Vienna
- Investigators
- Heinz Kölbl, Univ.-Prof.Dr.Dr.h.c., Principal investigator, Medical University of Vienna, Department of Obstetrics and Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023502
- Sponsor's protocol ID
- EK 1788/2013
- Status last verified
- Mar 2024
- First submitted
- 18 Nov 2013
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8623794Elia 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.
PubMed 12114888Chen 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.
PubMed 16126751Hu S, Loo JA, Wong DT. Human body fluid proteome analysis. Proteomics. 2006 Dec;6(23):6326-53. doi: 10.1002/pmic.200600284.
PubMed 17083142Ho 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.
PubMed 15850675Semmes 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.
PubMed 15613711Petricoin 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.
PubMed 11867112
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study
- ClinicalTrials.gov ID
- NCT02023502
- Acronym / sponsor ID
- EK 1788/2013
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- female stress urinary incontinence, proteomics, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Methods:
Sample preparation and analysis will include:
- Sample collection and immediate addition of protease inhibitor cocktail (Roche, Complete Protease Inhibitor Cocktail).
- Urine centrifugation and filtration for removal of cell debris.
- Protein precipitation by applying methanol/chloroform separation for removal of all possible non-proteinic substances.
- Protein digestion applying in-solution trypsin, pepsin, and Glu-C.
- Peptide separation using nano HPLC and different chromatographic approaches.
- Reversed phase (RP) separation of peptides and MS detection
- Separation of peptides using HILIC (hydrophilic Interaction Liquid Chromatography) for discrimination of polar peptides.
- In addition to RP and HILIC directly coupled to MS, digested peptides will be separated using multidimensional approaches. Weak anion exchange columns operated under HILIC conditions will be used to separate peptides carrying posttranslational modifications such as phosphorylation or acetylation, thus, increasing the dynamic range of detection. During this separation, fractions will be collected and re-injected onto the RP and HILIC with MS detection.
- All nano HPLC separations will be performed using biocompatible separation system.
Mass spectrometric analysis of digested peptides will be performed using two different detection methods: ion-trap and the time-of-flight (qToF) MS. qToF mass spectrometric detection and analysis will also be used for the label-free quantitation of peptides and proteins detected in samples. All measurements will be performed in triplicate to provide corrections for technical variability of separation and ionization.
General database search will be performed using the Human SwissProt Database in its actual version at the time of analysis. Data search will be performed using Mascot (http://www.matrixscience.com/) and X!Tandem (http://www.thegpm.org/tandem/) search machines, and the final data allocation and filtering by using Scaffold (www.proteomsoftware.com).
Statistical analysis:
Data analysis will be conducted with the bioconductor package limma. Before data analysis, data will be filtered by excluding proteins with measurements with a low interquartile range. Groups will be compared by moderated paired t-statistics adjusting for age. Adjustment for multiple testing will be done by Benjamini-Hochberg correction controlling the FDR at 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stress urinary incontinence | – | Other: collection of urine and blood samplePatients presenting with stress urinary incontinence according to the inclusion and exclusion criteria |
| healthy controls | – | Other: collection of urine and blood samplehealthy women with the same inclusion and exclusion criteria as the case group, except for stress urinary incontinence |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of urine and blood sample | Other | healthy controls, stress urinary incontinence |
Primary outcome
mass spectrometric measuring of urinary proteomic secretome in diseased and healthy subjects (sequence coverage and number of identified proteins)
Time frame: The primary outcome measure will be assessed for each participant in a time frame of 4-7 days after recruitment
Comparison of protein concentrations based on number of identified proteins and mass spectrometric spectral count for patients with stress urinary incontinence and healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 8623794Mushkat 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.
- Background: PubMed 12114888Elia 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.
- Background: PubMed 16126751Chen 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.
- Background: PubMed 17083142Hu S, Loo JA, Wong DT. Human body fluid proteome analysis. Proteomics. 2006 Dec;6(23):6326-53. doi: 10.1002/pmic.200600284.
- Background: PubMed 15850675Ho 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.
- Background: PubMed 15613711Semmes 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.
- Background: PubMed 11867112Petricoin 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.
Related trials for Female Stress Urinary Incontinence
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinz Kölbl, Univ.-Prof.Dr.Dr.h.c. principal investigator
Medical University of Vienna, Department of Obstetrics and Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Stress Urinary Incontinence, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mass spectrometric measuring of urinary proteomic secretome in diseased and healthy subjects (sequence coverage and number of identified proteins) (time frame: The primary outcome measure will be assessed for each participant in a time frame of 4-7 days after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023502, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.