Pentosan Polysulfate Treatment's Effectiveness | NCT05744908

Studies
Pentosan Polysulfate Treatment's Effectiveness

NCT05744908

Sponsor

Hisar Intercontinental Hospital

Status

Completed

Last Update Posted

May 22, 2025Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Chronic Interstitial Cystitis

Interventions

Pentosan Polysulphate

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Jan 10, 2023Actual

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Feb 15, 2023

First Posted Date

Feb 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2025

Last Update Posted Date

May 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Basri Cakiroglu, Principal Investigator, Hisar Intercontinental HospitalPrincipal Investigator

Lead Sponsor

Hisar Intercontinental HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With Hunner's ulcer	Active Comparator	Pentosan Polysulfate 100 mg	Other: Pentosan Polysulphate
Without Hunner's ulcer	Active Comparator	Pentosan Polysulfate 100 mg	Other: Pentosan Polysulphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pentosan Polysulphate	Other	300mg 3 times a day	With Hunner's ulcer Without Hunner's ulcer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic interstitial cystitis
Bladder Pain Syndrome

Exclusion Criteria:

Acute cystitis
Bladder cancer
Chronic prostatitis
Bladder stone
Stress incontinence

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Basri Cakiroglu		Istanbul		34768	Turkey (Türkiye)
Hisar Intercontinental Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010426	Pentosan Sulfuric Polyester

Ancestor Terms

ID	Term
D013464	Sulfuric Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided