Dataset Information

Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index.

ABSTRACT:

Introduction and hypothesis

A prospective clinical, preliminary study was performed in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) who were nonresponders to conventional treatment and received intravesical ozone as a therapeutic alternative.

Methods

Sixteen patients received six applications of intravesical ozone at a concentration of 41 μg/mL. We evaluated therapeutic efficacy by the percentage reduction of Interstitial Cystitis Symptom and Problem Index scores (ICSI/ICPI-the O'Leary-Sant symptom index), recurrence rate, nonresponse, and side effects in scores collected on admission (pre-treatment), at the end of the therapeutic protocol (post-treatment), and 180 days (follow-up) after the last ozone application.

Results

The mean age of women was 52.9 years (SD: 15.5), and the duration of symptoms was 5.7 years (SD: 7.1). The median ICSI on admission was 17 (IQR: 14.25-19.5) and at follow-up was 0.5 (IQR: 0-2), with a reduction of 97.5% (CI: 85.7-100). The median ICSI/ICPI on admission was 31.5 (IQR: 29-35.2) and at follow-up was 2.0 (IQR: 0-3.75), with a reduction of 92.3% (CI: 88.8-100). The recurrence rate was only 6.25%, and no patients were nonresponders to the treatment.

Conclusions

The application of intravesical ozone was effective in the treatment of patients with IC/BPS who were nonresponders to conventional therapy, showing a progressive and safe effect, at least in the short term.

SUBMITTER: Pires MV

PROVIDER: S-EPMC9569001 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index.

Pires Maria Verônica MV de Lima Carlos José CJ Carvalho Henrique Cunha HC Moreira Lívia Helena LH Fernandes Adriana Barrinha AB

International urogynecology journal 20221015 7

<h4>Introduction and hypothesis</h4>A prospective clinical, preliminary study was performed in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) who were nonresponders to conventional treatment and received intravesical ozone as a therapeutic alternative.<h4>Methods</h4>Sixteen patients received six applications of intravesical ozone at a concentration of 41 μg/mL. We evaluated therapeutic efficacy by the percentage reduction of Interstitial Cystitis Symptom and Problem Index sc ...[more]

PMID: 36242631

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Project description:Interstitial cystitis/bladder pain syndrome (IC/BPS) is a painful recurrent condition characterized by the discomfort of the bladder, and current treatment options have limited effectiveness. Prolotherapy is a well-known treatment that involves the injection of non-biologic solutions to reduce pain and/or promote proliferation of soft tissue, and dextrose is the most common injectate. This study investigated the effects of dextrose prolotherapy in a rat model of IC/BPS and patients with IC/BPS. We used cyclophosphamide to induce IC/BPS in rats, and intravesical instillation of 10% dextrose solution was performed. After 1 week, we conducted a urodynamic test, bladder staining, and ECM-related gene expression analysis to examine the treatment's efficacy. We found that dextrose treatment could recover the instability of the bladder, reduce frequent urination, and improve the glycosaminoglycan layer regeneration and the bladder wall thickness along with a significant intense expression of CD44 receptors. Furthermore, we enrolled 29 IC/BPS patients with previous hyaluronic acid/Botox treatment for more than 6 months with remained unchanged condition. In this study, they received intravesical injections of 10% dextrose solution followed by assessments for up to 12 weeks. Patient characteristics and a 3-day voiding diary before treatment were recorded. Patient responses were examined using IC/BPS-related questionnaires. Moreover, expressions of growth factors and cytokines were analyzed. The results demonstrated that dextrose prolotherapy in patients with IC/BPS reduced the frequency of treatment over time, with the mean number of treatments being 3.03 ± 1.52, and significantly reduced the incidence of nocturia and questionnaire scores associated with symptoms. Dextrose prolotherapy significantly enhanced EGF level and, in contrast, reduced the level of HGF, PIGF-1, and VEGF-D after several weeks following treatment. The cytokine analysis showed that the expressions of IL-12p70 and IL-10 were significantly up-regulated after dextrose prolotherapy in IC/BPS patients. The levels of most growth factors and cytokines in IC/BPS patients had no significant difference and showed a similar tendency as time progressed when compared to healthy controls. Overall, the alteration of growth factors and cytokines exhibited safe treatment and potential stimulation of tissue remodeling. In summary, our study demonstrated that dextrose prolotherapy is a promising treatment strategy for IC/BPS disease management.

Project description:ImportanceInterstitial cystitis (IC) is a debilitating condition. Although viral infection is a potential etiological cause, few studies have detected the effect of antiviral treatment.ObjectiveTo determine the efficacy and safety of intravesical interferon instillation compared with hyaluronic acid in female patients with IC.Design, setting, and participantsThis double-masked, randomized phase 2/3 clinical trial with parallel group design was implemented from October 2022 to April 2023 and had a 6-month follow-up period. The study was conducted at a single center. Eligible participants were female patients aged 18 to 70 years with a diagnosis of IC for more than 6 months. The last visit took place in October 2023. Data were analyzed between October and November 2023.InterventionPatients were randomized 1:1 to receive either intravesical instillation of interferon or hyaluronic acid.Main outcomes and measuresThe primary end point was change in visual analog scale pain score. Secondary end points included changes in voiding frequency, functional bladder capacity, symptom index, and global response assessment. Adverse events were closely monitored.ResultsAmong the 52 patients, the mean (SD) age was 50.0 (14.1) years and they were randomized to either the interferon group (26 [50%]) or hyaluronic acid (26 [50%]). The visual analog pain score showed the interferon group decreased more significantly than hyaluronic acid (-1.3; 95% CI, -2.3 to -0.3; P = .02) at month 6, with 20 patients (77%) exhibiting a 30% or higher reduction in pain compared with baseline. Secondary end points of voiding frequency, functional bladder capacity, and nocturia episodes showed no significant difference between 2 therapies. However, interferon showed a significantly higher reduction in the Interstitial Cystitis Symptom Index (-3.0; 95% CI, -5.3 to -0.7; P = .01) and the Problem Index (-2.5; 95% CI, -4.5 to -0.4; P = .02) at month 6, with 22 patients (85%) presenting as moderately or markedly improved. The frequencies of adverse events were similar between 2 groups. Only 1 patient discontinued hyaluronic acid because of poor effectiveness.Conclusions and relevanceIn this randomized clinical trial, female patients with IC could benefit from intravesical interferon therapy, without serious adverse events. These results offered hope for antiviral approaches in IC, but larger-scale, multicenter trials and long-term follow-up should be considered.Trial registrationClinicalTrials.gov Identifier: NCT05912946.

Dataset Information

Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index.

Introduction and hypothesis

Methods

Results

Conclusions

Publications

Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index.

Similar Datasets

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