Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

NeuroTherapia, Inc.

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Urinary Retention

Treatments: Drug: Tamsulosin 0.4Mg Capsule; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04232683

FLA 19-073

Details and patient eligibility

About

Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

Full description

This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

Enrollment: 100 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.

ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Exclusion criteria

i. Diagnosis of urinary retention preoperatively (post void residual >150ml)

ii. Malignancy

iii. History of neurological disease

iv. History of spinal cord injuries

v. Allergy to Tamsulosin

vi. Perioperative complications requiring prolonged postoperative bladder drainage

vii. Incontinence procedures other than mid-urethral slings

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Preoperative Tamsulosin

Experimental group

Description:

The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.

Treatment:

Drug: Tamsulosin 0.4Mg Capsule

Preoperative Placebo

Placebo Comparator group

Description:

The control group will receive one oral dose of placebo pill prior to surgery.

Treatment:

Drug: Placebo oral tablet