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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | 4 weeks | A bowel movement is considered a spontaneous bowel movement (SBM) if no laxative, enema, or suppository was taken in the preceding 24 hours. |
| Primary | Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | 4 weeks | If 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | 4 weeks | spontaneous bowel movements per week | MEAN | |
| PRIMARY | Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | 4 weeks | complete SBM per week | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | Control Placebo | 1.6 | Standard Error 0.3 | spontaneous bowel movements per week | |
| Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | Control Alfuzosin | 1.3 | Standard Error 0.1 | spontaneous bowel movements per week | |
| Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | Constipation Placebo | 1.6 | Standard Error 0.4 | spontaneous bowel movements per week | |
| Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | Constipation Alfuzosin | 1.3 | Standard Error 0.1 | spontaneous bowel movements per week | |
| Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | Control Placebo | 0.6 | Standard Error 0.1 | complete SBM per week | |
| Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | Control Alfuzosin | 0.7 | Standard Error 0.05 | complete SBM per week | |
| Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | Constipation Placebo | 0.7 | Standard Error 0.1 | complete SBM per week | |
| Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | Constipation Alfuzosin | 0.7 | Standard Error 0.1 | complete SBM per week |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Placebo | 18 | |
| Overall Study | STARTED | Control Alfuzosin | 20 | |
| Overall Study | STARTED | Constipation Placebo | 18 | |
| Overall Study | STARTED | Constipation Alfuzosin | 18 | |
| Overall Study | COMPLETED | Control Placebo | 17 | |
| Overall Study | COMPLETED | Control Alfuzosin | 19 | |
| Overall Study | COMPLETED | Constipation Placebo | 15 | |
| Overall Study | COMPLETED | Constipation Alfuzosin | 16 | |
| Overall Study | NOT COMPLETED | Control Placebo | 1 | |
| Overall Study | NOT COMPLETED | Control Alfuzosin | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Cardiac disorders | Control Placebo | 0 | 18 | 0 |
| other | Hypotension | Cardiac disorders | Control Alfuzosin | 1 | 20 | 1 |
| other | Hypotension | Cardiac disorders | Constipation Placebo | 0 | 18 | 0 |
| other | Hypotension | Cardiac disorders | Constipation Afluzosin | 0 | 18 | 0 |
| other | Headache | General disorders | Control Placebo | 0 | 18 | 0 |
| other | Headache | General disorders | Control Alfuzosin | 0 | 20 | 0 |
| other | Headache | General disorders | Constipation Placebo | 0 | 18 | 0 |
| other | Headache | General disorders | Constipation Afluzosin | 1 | 18 | 1 |
| other | Fatigue | General disorders | Control Placebo | 0 | 18 | 0 |
| other | Fatigue | General disorders | Control Alfuzosin | 0 | 20 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Placebo | 0 | 18 |
| Total, all-cause mortality | Control Alfuzosin | 0 | 20 |
| Total, all-cause mortality | Constipation Placebo | 0 | 18 |
| Total, all-cause mortality | Constipation Afluzosin | 0 | 18 |
| Total, other adverse events | Control Placebo | 0 | 18 |
| Total, other adverse events | Control Alfuzosin | 1 | 20 |
| Total, other adverse events | Constipation Placebo | 1 | 18 |
| Total, other adverse events | Constipation Afluzosin | 1 | 18 |
| Total, serious adverse events | Control Placebo | 0 | 18 |
| Total, serious adverse events | Control Alfuzosin | 0 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30130627 | RESULT |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01DK078924 | Pathophysiology of Anorectal Disorders | BHARUCHA, ADIL E. | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2023 | NIH RePORTER |
| UL1RR024150 | Mayo Clinic Center for Translational Science Activities | RIZZA, ROBERT A. | MAYO CLINIC ROCHESTER | NATIONAL CENTER FOR RESEARCH RESOURCES | 2006 to 2011 | NIH 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.
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