Health TrialsbyHealthPanel

Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

ConditionUrinary Retention Postoperative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About this trial

The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

willing and able to provide informed consent

postoperative urinary retention as defined by a failed RGVT prior to hospital discharge

Ability to speak and read English

Disqualifiers

allergy/intolerance to Tamsulosin or sulfa drugs

preoperative history of urinary retention as defined by preoperative post void residual of >150mL

current use of alpha antagonist medication for hypertension

severe dementia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamsulosin

    Drug

    Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.

  • Placebo

    Drug

    Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: TamsulosinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To determine the impact of Tamsulosin on duration of urinary retention

The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.

Time frame
Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course

Secondary outcomes

1

To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).

The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 \^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures.

Time frame
Date of failed the retrograde voiding trial and up to 6 weeks.
2

To quantify the effect of Tamsulosin on patient quality of life.

Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems).

Time frame
Prior to discharge and again at 2 weeks follow up

Other outcomes

Sponsors and contacts

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

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead sponsor

Johns Hopkins University

Collaborator

Source ClinicalTrials.gov
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