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NCT Number: NCT06863220

Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

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.

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Key information

Conditions

Interstitial Cystitis Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Patients received either 50 mL ozonated saline (20-40 µg/mL), normal saline (placebo), or continued standard care twice weekly for 3 weeks. Assessments were conducted at baseline, week 3, and week 6. The study aimed to determine if ozone therapy reduces interstitial cystitis symptoms compared to placebo and standard care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years
  • Histopathologically or clinically confirmed IC (per AUA guidelines)
  • Symptoms for at least 6 months
  • Willing to provide informed consent

Exclusion criteria

  • Active urinary tract infection
  • Bladder malignancy
  • Pregnancy or breastfeeding
  • Known ozone allergy
  • Intravesical therapy within 3 months
  • G6PD deficiency

Treatment and study plan

Intravesical Ozone Therapy

Other

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

Placebo (Normal Saline)

Other

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

Control

Other

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

Primary outcomes

  1. Change in O'Leary-Sant ICSI Score

    Time frame: Baseline to Week 3

    Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).

Secondary outcomes

  1. VAS pain score

    Time frame: baseline to week 3

    Reduction in pelvic pain measured by Visual Analog Scale (range 0-10).

  2. Change in Daily Urinary Frequency

    Time frame: baseline to week 3

    Reduction in average daily voiding frequency via 3-day voiding diary.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali İhsan Memmi

CONTACT

[email protected]

90 0537 922 0997

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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