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Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

M

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

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

Trial contacts and locations

1

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Central trial contact

Ali İhsan Memmi

Data sourced from clinicaltrials.gov

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