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Mindfulness-based stress reduction as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial.

ABSTRACT: Mindfulness-based stress reduction (MBSR) is a standardized meditation program that may be an effective therapy for interstitial cystitis/bladder pain syndrome (IC/BPS), a condition exacerbated by stress. The aims of this study were to explore whether MBSR improved IC/BPS symptoms and the feasibility/acceptability of MSBR among women with IC/BPS.This randomized controlled trial included women with IC/BPS undergoing first- or second-line therapies. Women were randomized to continuation of usual care (UC) or an 8-week MBSR class?+?usual care (MBSR). Participants completed baseline and 8-week post-treatment questionnaires, including the O'Leary-Sant Symptom Problem Index (OSPI), the visual analog pain scale (VAS), the Short Form Health Survey (SF-12), the Female Sexual Function Index (FSFI), and the Pain Self-Efficacy Questionnaire (PSEQ). The Global Response Assessment (GRA) was completed post-treatment. Analyses were performed using Student's t test, Chi-squared, and MANOVA where appropriate.Eleven women were randomized to UC and 9 to MBSR, without differences in group characteristics. More MBSR participants' symptoms were improved on the GRA (7 out of 8 [87.5 %] vs 4 out of 11 [36.4 %], p?=?0.03). The MBSR group showed greater improvement in the OSPI total (p?=?0.0498) and problem scores (p?=?0.036); the OSPI symptom score change did not differ. PSEQ scores improved in MBSR compared with UC (p?=?0.035). VAS, SF-12, and FSFI change did not differ between groups. Eighty-six percent of MBSR participants felt more empowered to control symptoms, and all participants planned to continue MBSR.This trial provides initial evidence that MBSR is a promising adjunctive therapy for IC/BPS. Its benefit may arise from patients' empowerment and ability to cope with symptoms.

SUBMITTER: Kanter G

PROVIDER: S-EPMC5067184 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Mindfulness-based stress reduction as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial.

Kanter Gregory G Komesu Yuko M YM Qaedan Fares F Jeppson Peter C PC Dunivan Gena C GC Cichowski Sara B SB Rogers Rebecca G RG

International urogynecology journal 20160426 11

<h4>Introduction and hypothesis</h4>Mindfulness-based stress reduction (MBSR) is a standardized meditation program that may be an effective therapy for interstitial cystitis/bladder pain syndrome (IC/BPS), a condition exacerbated by stress. The aims of this study were to explore whether MBSR improved IC/BPS symptoms and the feasibility/acceptability of MSBR among women with IC/BPS.<h4>Methods</h4>This randomized controlled trial included women with IC/BPS undergoing first- or second-line therapi ...[more]

PMID: 27116196

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Project description:Purpose of the Meeting:Bladder pain syndrome/interstitial cystitis is a prevalent but underserved disease. At the Global Interstitial Cystitis/Bladder Pain Syndrome Society (GIBS) meeting, the organization and participants were committed to delivering word-class expertise and collaboration in research and patient care. Under the umbrella of GIBS, leading research scholars from different backgrounds and specialties, as well as clinicians, from across the globe interested in the science and art of practice of Bladder Pain Syndrome (BPS)/Interstitial Cystitis (IC) were invited to deliberate on various dimensions of this disease. The meeting aimed to have global guidelines to establish firm directions to practicing clinicians and patients alike on the diagnosis and treatment of this disease entity. Chronic Pelvic Pain Syndrome (CPPS) is defined by pain in the pelvic area that can have different etiologies. This can be due to urologic, gynecologic, musculoskeletal, gastrointestinal, neurologic, and autoimmune or rheumatologic diseases. At the GIBS meeting held in Mumbai, India, in August 2019, a multidisciplinary expert panel of international urologists, gynecologists, pain specialists, and dietitians took part in a think tank to discuss the development of evidence-based diagnostic and treatment algorithms for BPS/IC. Summary of Presented Findings:The diagnosis of BPS/IC is difficult in daily clinical practice. Patients with BPS/IC present with a variety of signs and symptoms and clinical test results. Hence, they might be misdiagnosed or underdiagnosed, and the correct diagnosis might take a long time. A good history and physical examination, along with cystoscopy, is a must for the diagnosis of IC/BPS. For the treatment, besides lifestyle management and dietary advice, oral medication and bladder instillation therapy, botulinum toxin, and sacral neuromodulation were discussed. The innovation in bladder instillation applicators, as well as battery-free neuromodulation through the tibial nerve, was discussed, as well. Recommendation for Future Research:As BPS/IC is complex, for many patients, several treatments are necessary at the same time. This was presented at GIBS 2019 as the piano model. In this way, a combination of treatments is tailored to an individual patient depending on the symptoms, age, and patients' characteristics. In the art of medicine, especially when dealing with BPS/IC patients, pressing the right key at the right time makes the difference.

Project description:This study was designed to evaluate the efficacy and safety of fulranumab, a fully human monoclonal antibody directed against nerve growth factor (NGF), for pain relief in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).In this multicenter, double-blind study, adults with IC/BPS (i.e., interstitial cystitis symptom index [ICSI] total score ?8) accompanied by chronic, moderate-to-severe pain were randomized to fulranumab 9 mg or matching placebo, administered subcutaneously at weeks 1, 5, and 9. The primary efficacy endpoint was change from baseline to study endpoint (week 12 or at withdrawal) in average daily pain intensity score. Key secondary endpoints included change from baseline to study endpoint in worst pain intensity score, ICSI total score, Pelvic Pain and Urgency/Frequency total score, Patient Perception of Bladder Condition score, and global response assessment.This study was terminated prematurely based on concern that this class may be associated with rapidly progressing osteoarthritis or osteonecrosis. Thirty-one patients (of the targeted 70 patients) were randomized, 17 to placebo and 14 to fulranumab, with 15 and 10 patients, respectively, receiving all 3 doses of double-blind treatment. In ANOVA analyses, there was no statistically significant difference between treatment groups for the primary endpoint (LS mean difference [95% CI] vs. placebo, -0.2 [-1.52, 1.10]) or any of the secondary endpoints. Fulranumab was well tolerated, with no patient discontinuing due to an adverse event or experiencing a joint-related serious adverse event over a 26-week follow-up period. No events related to the neurologic or motor systems were reported.Efficacy was not demonstrated in the present study with the single dose tested and a limited sample size, leading to lack of statistical power. These findings do not exclude the possibility that fulranumab would provide clinical benefit in a larger study and/or specific populations (phenotypes) in this difficult to treat pain condition.NCT01060254 , registered January 29, 2010.

Dataset Information

Mindfulness-based stress reduction as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial.

Publications

Mindfulness-based stress reduction as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial.

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