Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 158 for:    interstitial cystitis

Clinical Features and Histologic Findings in Bladder Pain Syndrome/Interstitial Cystitis (HistologyIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03069053
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Daniele Porru, IRCCS Policlinico S. Matteo

Brief Summary:

Objectives- to find out whether a correlation exists between denudation of urothelium and diagnosic delay in patients with BPS / IC, secondary aim was to search a correlation between impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with BPS-IC.

Patients and Methods- Fifty-seven consecutive patients underwent cystoscopy under anaesthesia to classify those cases suspected of BPS/IC. As for the evaluation of the ICSI-ICPI scores we considered significant relevant values those ≥ 12. Patients underwent cystoscopy with hydrodistension under general (90%) or locoregional anaesthesia. Bladder biopsies were taken, including detrusor muscle, from those areas with the most apparent bladder wall lesions. All biopsies were then fixed in 4% formalin and sent to the Pathologist for examination.


Condition or disease
Interstitial Cystitis, Chronic Painful Bladder Syndrome

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 14 Years
Official Title: Clinical Features and Histologic Findings in Bladder Pain Syndrome/Interstitial Cystitis (BPS/IS): New Findings on Useful Correlations
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : February 20, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. correlation between denudation of urothelium and diagnosic delay [ Time Frame: 11 years ]
    to find out whether a correlation exists between denudation of urothelium and diagnosic delay in patients with BPS / IC


Secondary Outcome Measures :
  1. correlation between impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with IC [ Time Frame: 11 years ]
    to search a correlation between impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with IC


Biospecimen Retention:   Samples Without DNA
bladder biopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Fifty-seven consecutive patients underwent cystoscopy under anaesthesia to classify those cases suspected of BPS/IC
Criteria

Inclusion Criteria:

  • Patients reported long-lasting irritative bladder symptoms, including urgency, daytime frequency of seven or more episodes, nocturia, and pain in the lower abdomen, lower back, vagina or perineum during filling or after micturition.

Exclusion Criteria:

  • Alternative diagnoses such as urinary tract infection (UTI) were excluded. Confusable diseases were ruled out by thorough history, clinical examination, urine analysis and imaging.

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): NCT03069053


Locations
Layout table for location information
Italy
Clinical Epidemiology and Biometric Unit, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Histology and Pathology Service, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Obstetric and Gynecological Clinic, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Urology Department Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Layout table for investigator information
Principal Investigator: DANIELE PORRU, MD FONDAZIONE IRCCS POLICLINICO SAN MATTEO, PAVIA, ITALY

Additional Information:

Layout table for additonal information
Responsible Party: Daniele Porru, Principal Invesigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT03069053     History of Changes
Other Study ID Numbers: IRCCSPSMATTEO
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases