Health TrialsbyHealthPanel

Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery

ConditionPostoperative Urinary Retention (POUR)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTriHealth Inc.

About this trial

The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Any surgery involving a non-urogynecologist

Patients already on an alpha blocker

Baseline hypotension

History of syncope

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamsulosin

    Drug

    This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively.

  • Placebo

    Drug

    This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Study ArmActive comparator 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Voiding trial on postoperative day 0

Whether or not patients pass or fail their postoperative voiding trial

Time frame
Day of surgery

Secondary outcomes

1

Secondary postoperative urinary retention

Patients who develop urinary retention after discharge

Time frame
2 weeks following surgery
2

Postoperative urinary tract infection

Patients who develop a urinary tract infection after surgery

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TriHealth Inc.

Lead sponsor

Source ClinicalTrials.gov
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