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Trial · NCT01834729

Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions

NCT01834729, Phase 2, Completed, Mayo Clinic; results first posted 2019-01-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions. Trials, record NCT01834729. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01834729

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions
NCT number
NCT01834729
Status
Completed
Phases
Phase 2
Enrollment
74 participants, actual
Lead sponsor
Mayo Clinic
Conditions
Constipation
Interventions
Alfuzosin, Placebo
First posted
2013-04-18
Last updated
2019-01-29
Results first posted
2019-01-11
Limitations and caveats
Men were not studied; baseline bowel diary was not preceded by a run-in period; treatment phase only lasted 2 weeks.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryWeekly Rate of Spontaneous Bowel Movements at 4 Weeks4 weeksA bowel movement is considered a spontaneous bowel movement (SBM) if no laxative, enema, or suppository was taken in the preceding 24 hours.
PrimaryWeekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks4 weeksIf the subject indicates that the spontaneous bowel movement (SBM) was associated with a sensation of complete bowel emptying, the SBM will be counted as a complete spontaneous bowel movement (CSBM).

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYWeekly Rate of Spontaneous Bowel Movements at 4 Weeks4 weeksspontaneous bowel movements per weekMEAN
PRIMARYWeekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks4 weekscomplete SBM per weekMEAN

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Weekly Rate of Spontaneous Bowel Movements at 4 WeeksControl Placebo1.6Standard Error 0.3spontaneous bowel movements per week
Weekly Rate of Spontaneous Bowel Movements at 4 WeeksControl Alfuzosin1.3Standard Error 0.1spontaneous bowel movements per week
Weekly Rate of Spontaneous Bowel Movements at 4 WeeksConstipation Placebo1.6Standard Error 0.4spontaneous bowel movements per week
Weekly Rate of Spontaneous Bowel Movements at 4 WeeksConstipation Alfuzosin1.3Standard Error 0.1spontaneous bowel movements per week
Weekly Rate of Complete Spontaneous Bowel Movements at 4 WeeksControl Placebo0.6Standard Error 0.1complete SBM per week
Weekly Rate of Complete Spontaneous Bowel Movements at 4 WeeksControl Alfuzosin0.7Standard Error 0.05complete SBM per week
Weekly Rate of Complete Spontaneous Bowel Movements at 4 WeeksConstipation Placebo0.7Standard Error 0.1complete SBM per week
Weekly Rate of Complete Spontaneous Bowel Movements at 4 WeeksConstipation Alfuzosin0.7Standard Error 0.1complete SBM per week

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDControl Placebo18
Overall StudySTARTEDControl Alfuzosin20
Overall StudySTARTEDConstipation Placebo18
Overall StudySTARTEDConstipation Alfuzosin18
Overall StudyCOMPLETEDControl Placebo17
Overall StudyCOMPLETEDControl Alfuzosin19
Overall StudyCOMPLETEDConstipation Placebo15
Overall StudyCOMPLETEDConstipation Alfuzosin16
Overall StudyNOT COMPLETEDControl Placebo1
Overall StudyNOT COMPLETEDControl Alfuzosin1

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHypotensionCardiac disordersControl Placebo0180
otherHypotensionCardiac disordersControl Alfuzosin1201
otherHypotensionCardiac disordersConstipation Placebo0180
otherHypotensionCardiac disordersConstipation Afluzosin0180
otherHeadacheGeneral disordersControl Placebo0180
otherHeadacheGeneral disordersControl Alfuzosin0200
otherHeadacheGeneral disordersConstipation Placebo0180
otherHeadacheGeneral disordersConstipation Afluzosin1181
otherFatigueGeneral disordersControl Placebo0180
otherFatigueGeneral disordersControl Alfuzosin0200

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityControl Placebo018
Total, all-cause mortalityControl Alfuzosin020
Total, all-cause mortalityConstipation Placebo018
Total, all-cause mortalityConstipation Afluzosin018
Total, other adverse eventsControl Placebo018
Total, other adverse eventsControl Alfuzosin120
Total, other adverse eventsConstipation Placebo118
Total, other adverse eventsConstipation Afluzosin118
Total, serious adverse eventsControl Placebo018
Total, serious adverse eventsControl Alfuzosin020

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30130627RESULT

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource
R01DK078924Pathophysiology of Anorectal DisordersBHARUCHA, ADIL E.MAYO CLINIC ROCHESTERNATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES2008 to 2023NIH RePORTER
UL1RR024150Mayo Clinic Center for Translational Science ActivitiesRIZZA, ROBERT A.MAYO CLINIC ROCHESTERNATIONAL CENTER FOR RESEARCH RESOURCES2006 to 2011NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01834729

GET https://conductscience.org/api/trials/v1/NCT01834729/registered