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Pentosan Polysulfate Treatment's Effectiveness

Primary Purpose

Chronic Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pentosan Polysulphate
Sponsored by
Hisar Intercontinental Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Interstitial Cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Chronic interstitial cystitis Bladder Pain Syndrome Exclusion Criteria: Acute cystitis Bladder cancer Chronic prostatitis Bladder stone Stress incontinence

Sites / Locations

  • Basri Cakiroglu
  • Hisar Intercontinental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

With Hunner's ulcer

Without Hunner's ulcer

Arm Description

Pentosan Polysulfate 100 mg

Pentosan Polysulfate 100 mg

Outcomes

Primary Outcome Measures

bladder wall thickness
0.3 over 3 mm 1 under 3 mm,
improvement of lower urinary tract symptoms
1 if symptoms improved, 0 if not

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
February 15, 2023
Sponsor
Hisar Intercontinental Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05744908
Brief Title
Pentosan Polysulfate Treatment's Effectiveness
Official Title
Retrospective Evaluation of the Effectiveness of Oral Pentosan Polysulfate Treatment in the Improvement of Chronic Interstitial Cystitis Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hisar Intercontinental Hospital

4. Oversight

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

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Interstitial Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
two models: with and without Hunner's ulcer
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With Hunner's ulcer
Arm Type
Active Comparator
Arm Description
Pentosan Polysulfate 100 mg
Arm Title
Without Hunner's ulcer
Arm Type
Active Comparator
Arm Description
Pentosan Polysulfate 100 mg
Intervention Type
Other
Intervention Name(s)
Pentosan Polysulphate
Intervention Description
300mg 3 times a day
Primary Outcome Measure Information:
Title
bladder wall thickness
Description
0.3 over 3 mm 1 under 3 mm,
Time Frame
Three months
Title
improvement of lower urinary tract symptoms
Description
1 if symptoms improved, 0 if not
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chronic interstitial cystitis Bladder Pain Syndrome Exclusion Criteria: Acute cystitis Bladder cancer Chronic prostatitis Bladder stone Stress incontinence
Facility Information:
Facility Name
Basri Cakiroglu
City
Istanbul
ZIP/Postal Code
34768
Country
Turkey
Facility Name
Hisar Intercontinental Hospital
City
Istanbul
ZIP/Postal Code
34768
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Pentosan Polysulfate Treatment's Effectiveness

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