Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01568918|
Recruitment Status : Recruiting
First Posted : April 2, 2012
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Urinary Retention||Drug: Tamsulosin hydrochloride Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Drug: Tamsulosin hydrochloride
Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Placebo Comparator: Placebo
Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge.
The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
- Incidence of postoperative urinary retention [ Time Frame: 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.
- Duration of postoperative urinary retention [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568918
|Contact: Sandy K Twaitesemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michelle Clarke, MD||Mayo Clinic|