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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04232683
• Other study ID #: FLA 19-073
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: December 18, 2019
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: February 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Urinary Retention

Intervention

Drug:
• Tamsulosin 0.4Mg Capsule
Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
• Placebo oral tablet
Placebo pill given preoperatively

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tamsulosin Effect	Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.	Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Secondary	Postoperative Narcotic Use	Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams)	Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Secondary	Effect of Tamsulosin on postoperative blood pressure	A side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure	Up to 4 hours after surgery while patient is in post-anesthesia care unit