Trial · NCT01568918
Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
NCT01568918, Phase 3, Terminated, Mayo Clinic; results first posted 2024-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery. Trials, record NCT01568918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01568918
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
- NCT number
- NCT01568918
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Postoperative Urinary Retention
- Interventions
- Tamsulosin hydrochloride, Placebo
- First posted
- 2012-04-02
- Last updated
- 2024-05-30
- Results first posted
- 2024-05-30
- Limitations and caveats
- Terminated study due to slow recruitment and enrollment.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Postoperative Urinary Retention | participants will be followed for the duration of the hospital stay, an expected average of 5 days | Post operative urinary retention (POUR) will be defined as any of the following: 1\) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml. |
| Secondary | Duration of Postoperative Urinary Retention | participants will be followed for the duration of the hospital stay, an expected average of 5 days | The neurosurgical team will decide if an indwelling urinary catheter will be used. Time of indwelling catheter removal after surgery will serve as time zero for beginning calculation of postoperative urinary retention duration if the patient later requires in and out straight catheterization. For patients without an indwelling catheter, the time patients leave the operating room will serve as time zero. Urinary retention will be considered resolved after two consecutive post-void residual urine scans have demonstrated less than 300 ml residual urine volume in a patient spontaneously voiding. |
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 | Incidence of Postoperative Urinary Retention | participants will be followed for the duration of the hospital stay, an expected average of 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Postoperative Urinary Retention | participants will be followed for the duration of the hospital stay, an expected average of 5 days | days | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Postoperative Urinary Retention | Tamsulosin | 11 | Participants | ||
| Incidence of Postoperative Urinary Retention | Placebo | 20 | Participants | ||
| Duration of Postoperative Urinary Retention | Tamsulosin | 3.42 | Standard Deviation 0.932 | days | |
| Duration of Postoperative Urinary Retention | Placebo | 3.52 | Standard Deviation 1.210 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tamsulosin | 39 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | COMPLETED | Tamsulosin | 39 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | Tamsulosin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Lower Extremity Edema | General disorders | Tamsulosin | 0 | 39 | 0 |
| other | Lower Extremity Edema | General disorders | Placebo | 1 | 51 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tamsulosin | 0 | 39 |
| Total, all-cause mortality | Placebo | 0 | 51 |
| Total, other adverse events | Tamsulosin | 0 | 39 |
| Total, other adverse events | Placebo | 1 | 51 |
| Total, serious adverse events | Tamsulosin | 0 | 39 |
| Total, serious adverse events | Placebo | 0 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tamsulosin vs Placebo: deaths from any cause | Trial comparisons |
| Tamsulosin vs Placebo: Incidence of Postoperative Urinary Retention | Trial comparisons |
| Tamsulosin vs Placebo: serious adverse events | Trial comparisons |
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/NCT01568918
GET https://conductscience.org/api/trials/v1/NCT01568918/registered