Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35+
SponsorMayo Clinic

About this trial

The purpose of this research is to see if the use of tamsulosin can decrease both the incidence and duration of urinary retention, as well as hospital length of stay following spine surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cervical Laminectomy

Cervical Posterior Fusion

Cervical Anterior/Posterior Fusion

Lumbar Laminectomy

Disqualifiers

Cervical Anterior Discectomy and Fusion

Cervical Anterior Corpectomy

Cervical Posterior Discectomy

Cervical Foraminotomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Uroselective alpha-1-adrenergic receptor antagonist

    Drug

    Subjects will receive Tamsulosin (0.4 mg daily) beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)

  • Placebo

    Other intervention

    Subjects will receive placebo beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of incidences of POUR (Postoperative urinary retention)

Total number of incidences of POUR (Postoperative urinary retention). POUR is defined as any of the following: estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; or patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml.

Time frame
Post-operatively through end of hospital stay, approximately 8-12 days

Secondary outcomes

1

Duration of POUR (Postoperative urinary retention)

Duration subjects experience postoperative urinary retention, reported in days

Time frame
Post-operatively through end of hospital stay, approximately 8-12 days
2

Number of intermittent catheterizations in those with urinary retention

Total number of catheterizations performed in subjects who experience urinary retention

Time frame
Post-operatively through end of hospital stay, approximately 8-12 days
3

Incidence of UTI (urinary tract infection)

Number of subjects to be diagnosed with a UTI (urinary tract infection) post-operatively

Time frame
Post-operatively through end of hospital stay, approximately 8-12 days
4

Duration of hospital stay

Total length of time subjects remain inpatient post-procedure, reported in days.

Time frame
Post-operatively through end of hospital stay, approximately 8-12 days

Other outcomes

Sponsors and contacts

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