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

NCT03069053 | Completed

• 1 other identifier: IRCCSPSMATTEO
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 4

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.

Conditions

Interstitial Cystitis, Chronic; Painful Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• correlation between denudation of urothelium and diagnosic delay

  to find out whether a correlation exists between denudation of urothelium and diagnosic delay in patients with BPS / IC

  11 years

Secondary Outcomes (1)

• correlation between impact of symptoms evaluated with ICSI-ICPI and number of comorbid conditions associated with IC

  11 years

Eligibility Criteria

• Age: 19 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fifty-seven consecutive patients underwent cystoscopy under anaesthesia to classify those cases suspected of BPS/IC

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (4)

Clinical Epidemiology and Biometric Unit, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Histology and Pathology Service, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Obstetric and Gynecological Clinic, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Urology Department Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

bladder biopsy

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• DANIELE PORRU, MD

  Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 14 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesigator

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: July 1, 2016
• Primary Completion: December 15, 2016
• Study Completion: February 20, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)