Evidence map›Paper›PMID 28528859›Full record

Trial reportUrology2017

Efficacy, Side Effects, and Monitoring of Oral Cyclosporine in Interstitial Cystitis-Bladder Pain Syndrome.

Iryna M Crescenze, Barbara Tucky, Jianbo Li, Courtenay Moore, Daniel A Shoskes

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Urology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Observational
  8. Review
  9. [Treatment of intravesical instillation with fulguration-hydrodistention on female interstitial cystitis].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2023
    Article
  10. Article
  11. Review
  12. Article
  13. [Urodynamic and histological evaluation of cyclophosphamide-induced bladder pain syndrome in SD rats].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2022
    Article
  14. Article
  15. An update on treatment options for interstitial cystitis.Przeglad menopauzalny = Menopause review · 2020
    Review
  16. Transplant immunosuppressive drugs in urology.Translational andrology and urology · 2019
    Review
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Iryna M CrescenzeGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.
Barbara TuckyGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.
Jianbo LiGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.
Courtenay MooreGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.
Daniel A ShoskesGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH. Electronic address: dshoskes@mac.com.
Cleveland Clinic · US

Funding

Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of ActionR01DK100936 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI SHOSKES, DANIEL · 2013 to 2013
$365k
NIDDK NIH HHS R01 DK100936
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of oral cyclosporine A (CyA) in the treatment of refractory interstitial cystitis-bladder pain syndrome (IC-BPS) and to assess safety using drug level and renal function monitoring. MATERIALS AND

methodsPatients with IC-BPS who failed at least 2 prior treatments were enrolled in an open-label study of oral CyA. Medication was started at 3 mg/kg divided twice daily for 3 months. Dose was adjusted based on side effects and the drug level was measured 2 hours after the morning dose (C2). The primary end point was moderate or marked improvement of global response assessment or >50% improvement on the Interstitial Cystitis Symptom Index (ICSI) or Interstitial Cystitis Problem Index at 3 months.

resultsTwenty-two of 26 patients completed the 3-month follow-up; 18 completed the poststudy evaluation. The median symptom duration was 66 months (12-336). At 3 months, 31% (8/26) improved by global response assessment, 15% (4/26) had >50% improvement in the ICSI score, and 19% (5/26) had an improvement in the Interstitial Cystitis Problem Index score. Hunner lesions (HLs) predicted an improvement in the ICSI score (odds ratio = 15.4, 95% confidence interval: 1.7-224.6, P = .01), with 75% (3/4) of the responders having HL. Two patients withdrew because of hypertension or elevated serum glucose. The mean nuclear glomerular filtration rate declined at 3 months (98.9 ± 31.6 vs 84.2 ± 25.5 mL/min/1.73 m

conclusionPer American Urological Association guidelines, CyA can be effective in a proportion of patients with refractory IC-BPS. Patients with HL are more likely to benefit. Monitoring of C2 rather than trough levels can lead to dose reduction, thereby minimizing toxicity.

Indexed as

Administration, OralAdolescentAdultAgedAged, 80 and overCyclosporineCystitis, InterstitialDose-Response Relationship, DrugDrug MonitoringFemaleFollow-Up StudiesHumansImmunosuppressive AgentsMaleMiddle AgedPainCyclosporineImmunosuppressive Agents

Identifiers

PMID28528859
PMCPMC5595648
OpenAlexW2615894655

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.