Chronic Interstitial CystitisNCT05744908
Pentosan Polysulfate Treatment's Effectiveness
A study testing Pentosan Polysulphate in people with Chronic Interstitial Cystitis, run by Hisar Intercontinental Hospital at 2 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Interstitial Cystitis
- What is being tested?
- Pentosan Polysulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic interstitial cystitis
- Bladder Pain Syndrome
Who cannot join
- Acute cystitis
- Bladder cancer
- Chronic prostatitis
- Bladder stone
- Stress incontinence
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Basri Cakiroglu
Istanbul, 34768
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Interstitial Cystitis
- Being tested
- Pentosan Polysulphate
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentosan PolysulphateOther
300mg 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| With Hunner's ulcer | Active comparator | Pentosan Polysulfate 100 mg Receives: Other: Pentosan Polysulphate |
| Without Hunner's ulcer | Active comparator | Pentosan Polysulfate 100 mg Receives: Other: Pentosan Polysulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder wall thickness
0.3 over 3 mm 1 under 3 mm,
Measured: Three months
improvement of lower urinary tract symptoms
1 if symptoms improved, 0 if not
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- two models: with and without Hunner's ulcer
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744908
- Sponsor's protocol ID
- 10.01.2023/37
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Effectiveness of Oral Pentosan Polysulfate Treatment in the Improvement of Chronic Interstitial Cystitis Symptoms
- ClinicalTrials.gov ID
- NCT05744908
- Acronym / sponsor ID
- 10.01.2023/37
- Conditions
- Chronic Interstitial Cystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two models: with and without Hunner's ulcer
| Arm | Type | Receives |
|---|---|---|
| With Hunner's ulcer | Active comparator | Other: Pentosan PolysulphatePentosan Polysulfate 100 mg |
| Without Hunner's ulcer | Active comparator | Other: Pentosan PolysulphatePentosan Polysulfate 100 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic interstitial cystitis
- Bladder Pain Syndrome
Key exclusion criteria (5 listed)
- Acute cystitis
- Bladder cancer
- Chronic prostatitis
- Bladder stone
- Stress incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentosan Polysulphate300mg 3 times a day | Other | With Hunner's ulcer, Without Hunner's ulcer |
Primary outcome
bladder wall thickness
Time frame: Three months
0.3 over 3 mm 1 under 3 mm,
improvement of lower urinary tract symptoms
Time frame: Three months
1 if symptoms improved, 0 if not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Interstitial Cystitis
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentosan Polysulphate in people with Chronic Interstitial Cystitis, run by Hisar Intercontinental Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder wall thickness (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.