NCT03023241

Brief Summary

To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

16 years

First QC Date

January 13, 2017

Last Update Submit

March 30, 2022

Conditions

Bladder Pain SyndromeInterstitial CystitisOveractive Bladder

Keywords

BPS/ICOAB

Outcome Measures

Primary Outcomes (1)

  • Identification of new diagnostic markers for BPS/IC

    2 days

Secondary Outcomes (1)

  • Identification of molecular details that lead to BPS/IC (pathogenesis).

    2 days

Study Arms (1)

all study patients

EXPERIMENTAL

Same intervention for all subjects: anamnesis, questionnaires and biological samples (bladder biopsy, bladder washing, blood and urine) are collected at one single visit.

Procedure: biopsy

Interventions

biopsyPROCEDURE

cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection

all study patients

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with diagnosed BPS/IC, OAB or healthy controls
  • included healthy controls must have another pelvic surgery planned (e.g. hysterectomy)
  • being able to act and judge

You may not qualify if:

  • unstable endocrinological situation
  • severe illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital Frauenfeld

Frauenfeld, Thurgau, 8501, Switzerland

Location

Related Publications (5)

  • Gamper M, Viereck V, Geissbuhler V, Eberhard J, Binder J, Moll C, Rehrauer H, Moser R. Gene expression profile of bladder tissue of patients with ulcerative interstitial cystitis. BMC Genomics. 2009 Apr 28;10:199. doi: 10.1186/1471-2164-10-199.

    PMID: 19400928RESULT

  • Gamper M, Viereck V, Eberhard J, Binder J, Moll C, Welter J, Moser R. Local immune response in bladder pain syndrome/interstitial cystitis ESSIC type 3C. Int Urogynecol J. 2013 Dec;24(12):2049-57. doi: 10.1007/s00192-013-2112-0. Epub 2013 May 14.

    PMID: 23670165RESULT

  • Gamper M, Regauer S, Welter J, Eberhard J, Viereck V. Are mast cells still good biomarkers for bladder pain syndrome/interstitial cystitis? J Urol. 2015 Jun;193(6):1994-2000. doi: 10.1016/j.juro.2015.01.036. Epub 2015 Jan 14.

    PMID: 25596361RESULT

  • Gamper M, Moser R, Viereck V. Have we been led astray by the NGF biomarker data? Neurourol Urodyn. 2017 Jan;36(1):203-204. doi: 10.1002/nau.22882. Epub 2015 Sep 18. No abstract available.

    PMID: 26384156RESULT

  • Regauer S, Gamper M, Fehr MK, Viereck V. Sensory Hyperinnervation Distinguishes Bladder Pain Syndrome/Interstitial Cystitis from Overactive Bladder Syndrome. J Urol. 2017 Jan;197(1):159-166. doi: 10.1016/j.juro.2016.06.089. Epub 2016 Jul 1.

    PMID: 27378135RESULT

MeSH Terms

Conditions

Cystitis, InterstitialUrinary Bladder, Overactive

Interventions

Biopsy

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Volker Viereck, Prof. Dr.

    Cantonal Hospital Frauenfeld, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 18, 2017

Study Start

December 1, 2004

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)