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Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

Primary Purpose

Bladder Pain Syndrome, Interstitial Cystitis, Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
biopsy
Sponsored by
Cantonal Hospital, Frauenfeld
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Pain Syndrome focused on measuring BPS/IC, OAB

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • unstable endocrinological situation
  • severe illness

Sites / Locations

  • Cantonal Hospital Frauenfeld

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all study patients

Arm Description

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

Outcomes

Primary Outcome Measures

Identification of new diagnostic markers for BPS/IC

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2017
Last Updated
March 30, 2022
Sponsor
Cantonal Hospital, Frauenfeld
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1. Study Identification

Unique Protocol Identification Number
NCT03023241
Brief Title
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis
Official Title
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital, Frauenfeld

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial cystitis (BPS/IC) for diagnosis of this disease.
Detailed Description
Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing, and immunohistochemistry techniques. Differences between patient groups are statistically evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Pain Syndrome, Interstitial Cystitis, Overactive Bladder
Keywords
BPS/IC, OAB

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all study patients
Arm Type
Experimental
Arm Description
Same intervention for all subjects: anamnesis, questionnaires and biological samples (bladder biopsy, bladder washing, blood and urine) are collected at one single visit.
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection
Primary Outcome Measure Information:
Title
Identification of new diagnostic markers for BPS/IC
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Identification of molecular details that lead to BPS/IC (pathogenesis).
Time Frame
2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: unstable endocrinological situation severe illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Viereck, Prof. Dr.
Organizational Affiliation
Cantonal Hospital Frauenfeld, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital Frauenfeld
City
Frauenfeld
State/Province
Thurgau
ZIP/Postal Code
8501
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19400928
Citation
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.
Results Reference
result
PubMed Identifier
23670165
Citation
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.
Results Reference
result
PubMed Identifier
25596361
Citation
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.
Results Reference
result
PubMed Identifier
26384156
Citation
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.
Results Reference
result
PubMed Identifier
27378135
Citation
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.
Results Reference
result

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Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis

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