NCT05744908

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
Last Updated

May 22, 2025

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

January 10, 2023

Last Update Submit

May 19, 2025

Conditions

Chronic Interstitial Cystitis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Pentosan PolysulphateOTHER

300mg 3 times a day

With Hunner's ulcerWithout Hunner's ulcer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic interstitial cystitis
  • Bladder Pain Syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basri Cakiroglu

Istanbul, 34768, Turkey (Türkiye)

Location

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Pentosan Sulfuric Polyester

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfuric AcidsSulfur AcidsSulfur CompoundsOrganic ChemicalsPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: two models: with and without Hunner's ulcer
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 27, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

January 10, 2023

Last Updated

May 22, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)