Evidence map›Paper›PMID 17694391›Full record

Trial reportWorld journal of urology2007

Prospective evaluation of candidate urine and cell markers in patients with interstitial cystitis enrolled in a randomized clinical trial of Bacillus Calmette Guerin (BCG).

Susan Keay, Jay E Reeder, Kristopher Koch, Chen-Ou Zhang, Daivd Grkovic, Kenneth Peters, Yawei Zhang, John W Kusek, Lee M Nyberg, Christopher K Payne and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 23% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. 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

11 authors at 1 institution in 1 country.

Susan KeayDepartment of Medicine, University of Maryland School of Medicine, 10 N. Greene Street, Baltimore, MD 21201, USA. skeay@medicine.umaryland.edu
Jay E Reeder
Kristopher Koch
Chen-Ou Zhang
Daivd Grkovic
Kenneth Peters
Yawei Zhang
John W Kusek
Lee M Nyberg
Christopher K Payne
Kathleen J Propert
University of Maryland, Baltimore · US

Funding

Zonulin Antibodies in Intestinal Permeabilitiy in IDDMM01RR016500 · NCRR · UNIVERSITY OF MARYLAND BALTIMORE · PI OSWALD, LYNN M · 2002 to 2009
$20.2M
DCC--INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUPU01DK054127 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI LANDIS, J RICHARD · 1998 to 2003
$4.3M
INTERSTITIAL CYSTITIS TRIALS GROUPU01DK054133 · NIDDK · TUFTS MEDICAL CENTER · PI SANT, GRANNUM R · 1998 to 2003
$1.5M
MARYLAND INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUPU01DK054125 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI WARREN, JOHN W · 1998 to 2003
$1.2M
BEAUMONT/FORD INTERSTITIAL CYSTITIS CLINICAL CENTERU01DK054108 · NIDDK · WILLIAM BEAUMONT HOSPITAL RESEARCH INST · PI DIOKNO, ANANIAS C · 1998 to 2003
$891k
INTERSTITIAL CYSTITIS PHASE II TRIALSU01DK054158 · NIDDK · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI CULKIN, DANIEL JOSEPH · 1998 to 2003
$696k
INTERSTITIAL CYSTITIS TREATMENT PROTOCOLSU01DK054138 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI WEIN, ALAN J · 1998 to 2003
$583k
NCRR NIH HHS M01 RR 16500NIDDK NIH HHS U01 DK54108NIDDK NIH HHS U01 DK54125NIDDK NIH HHS U01 DK54127NIDDK NIH HHS U01 DK54133NIDDK NIH HHS U01 DK54138NIDDK NIH HHS U01 DK54158
6 · The paper itself

Abstract

We measured candidate urine biomarkers and bladder cell DNA cytometry in interstitial cystitis (IC) patients randomized to receive intravesical Bacillus Calmette Guerin (BCG) or placebo in a multicenter trial. Participants received 6 weekly instillations and were followed for 34 weeks. Urine was collected at baseline, prior to fourth treatment, and at study end. Antiproliferative factor (APF) activity was determined by 3H-thymidine incorporation assay; heparin-binding epidermal growth factor-like growth factor (HB-EGF) and epidermal growth factor-like growth factor (EGF) levels were determined by ELISA. Cellular DNA content was measured by image analysis to determine the mean hyperdiploid fraction (HDF) of the urine cell pellet. Associations between marker levels, and treatment or symptoms, were examined. Baseline APF positivity rate and mean levels of the other biomarkers were similar to previous smaller studies. During the week 34 follow-up, mean HDF decreased (P = 0.0003) and HB-EGF increased (P < 0.0001); both correlated weakly with decreased urgency. There was no difference in any biomarker between symptom responders and non-responders, but the percentage of responders was low and not significantly different for BCG versus placebo. APF positivity, decreased HB-EGF, increased EGF, and increased HDF were confirmed at baseline in IC patients. Changes in HDF and HB-EGF levels correlated weakly with changes in urgency, but the low BCG response rate prevented identification of additional associations between biomarker changes and treatment or symptoms.

Indexed as

Administration, IntravesicalAdultBiomarkersCystitis, InterstitialDouble-Blind MethodEpithelial CellsFemaleHumansMaleMiddle AgedMycobacterium bovisProspective StudiesUrinary BladderBiomarkers

Identifiers

PMID17694391
OpenAlexW2030971982

What OpenQuestion holds

Textmetadata
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.