Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Interstitial Cystitis Bladder Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ozone Therapy Group

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

Group Type EXPERIMENTAL

Intravesical Ozone Therapy

Intervention Type OTHER

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

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type OTHER

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

Control Group

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

Group Type OTHER

Control

Intervention Type OTHER

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

Interventions

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