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Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

NCT06863220 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-27

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (IC). Participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. The primary outcome was the change in O'Leary-Sant ICSI score. Secondary outcomes included VAS pain score, SF-36 physical health, and urinary frequency.

Conditions

  • Interstitial Cystitis
  • Bladder Pain Syndrome

Interventions

OTHER

Intravesical Ozone Therapy

Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.

OTHER

Placebo (Normal Saline)

Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.

OTHER

Control

Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.

Sponsors & Collaborators

  • Medipol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-04-01
Completion
2026-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863220 on ClinicalTrials.gov