Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

Medipol University

Status: Begins enrollment this month

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Other: Control; Other: Placebo (Normal Saline); Other: Intravesical Ozone Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06863220

340434043404

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Ozone Therapy Group

Experimental group

Description:

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

Treatment:

Other: Intravesical Ozone Therapy

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (Normal Saline)

Control Group

Other group

Description:

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

Treatment:

Other: Control