Pentosan Polysulfate Treatment's Effectiveness

Retrospective Evaluation of the Effectiveness of Oral Pentosan Polysulfate Treatment in the Improvement of Chronic Interstitial Cystitis Symptoms.

To examine the relationship between symptoms and quality of life before and after oral pentosan polysulfate (PPS) treatment in cases diagnosed with interstitial cystitis/painful bladder syndrome (IC/BPS).

Study Overview

• Status: Completed
• Conditions: Chronic Interstitial Cystitis
• Intervention / Treatment: Other: Pentosan Polysulphate

Detailed Description

Demographic characteristics, medical history, clinical conditions, and laboratory and cystoscopic data of patients who applied to our clinic between January 2018 and December 2021 and were diagnosed with IC/BPS were retrospectively analyzed. Adult male and female patients with IC/BPS who received 300 mg/day PPS at least six months ago with complaints of pain, urge, frequency, and nocturia not associated with urinary tract infection were included in the study. In addition, pre- and post-treatment symptoms, ICSI scores, quality of life (scored between 1-4), and satisfaction were compared.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34768
    • Hisar Intercontinental Hospital
  • Istanbul, Turkey, 34768
    • Basri Cakiroglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic interstitial cystitis
• Bladder Pain Syndrome

Exclusion Criteria:

• Acute cystitis
• Bladder cancer
• Chronic prostatitis
• Bladder stone
• Stress incontinence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With Hunner's ulcer; Pentosan Polysulfate 100 mg	Other: Pentosan Polysulphate; 300mg 3 times a day
Active Comparator: Without Hunner's ulcer; Pentosan Polysulfate 100 mg	Other: Pentosan Polysulphate; 300mg 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bladder wall thickness	0.3 over 3 mm 1 under 3 mm,	Three months
improvement of lower urinary tract symptoms	1 if symptoms improved, 0 if not	Three months

Collaborators and Investigators

• Sponsor: Hisar Intercontinental Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Anticoagulants; Pentosan Sulfuric Polyester
• Other Study ID Numbers: 10.01.2023/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No