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Alpha-1 Blocker

Tamsulosin for Urinary Retention After Pelvic Surgery

Q: What is the total number of participants for this research endeavor?

Participants are not being sought for this clinical trial at present. The study was initially advertised on 18th December 2019 and had its last edit on 5th October 2022. If you're seeking alternative trials, there currently exist 53 research studies actively recruiting patients with pelvic floor disorders and 13 investigations searching for participants to test preoperative tamsulosin.

Q: What past research has been conducted concerning the efficacy of Preoperative Tamsulosin?

Currently, 13 different research initiatives are analyzing the efficacy of preoperative tamsulosin. Of these studies 3 have reached phase three and many take place in Baden Aargau. Nonetheless, across the world there are still a total of thirteen sites running trials for this drug.

Q: Is the recruitment of participants still in progress for this investigation?

As of October 5th 2022, the clinical trial has ceased recruitment. Originally posted on December 18th 2019, this study is currently closed to new patients. Other studies that may be relevant include 53 trials actively enrolling participants with pelvic floor disorders and 13 studies for Preoperative Tamsulosin recruiting individuals.

Q: What is the typical use case for Preoperative Tamsulosin?

Preoperative Tamsulosin is an effective treatment for bladder outlet obstruction, ureteral calculus and Benign Prostatic Hyperplasia (<a href="https://www.withpower.com/clinical-trials/bph">BPH</a>).

Phase < 1

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 hours after surgery while patient is in post-anesthesia care unit

Awards & highlights

Study Summary

This trial will test whether the drug Tamsulosin can reduce the rates of POUR in female patients after surgery for pelvic floor disorders.

Who is the study for?

This trial is for female patients undergoing surgery for pelvic floor disorders, including various vaginal, laparoscopic, and robotic surgeries. Candidates must not have preoperative urinary retention, cancer, neurological diseases or spinal cord injuries. They also can't be allergic to Tamsulosin or need long-term post-surgery bladder drainage.Check my eligibility

What is being tested?

The study tests if taking Tamsulosin before surgery reduces the chances of having difficulty urinating after pelvic floor disorder surgery. Participants will either receive Tamsulosin or a placebo tablet without knowing which one they are getting.See study design

What are the potential side effects?

Tamsulosin may cause dizziness, headache, sleepiness, nausea, low blood pressure upon standing up (which can make you feel faint), and in rare cases a painful erection that won’t go away.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had surgery for pelvic organ prolapse or incontinence.

Select...

I am having surgery for prolapse, possibly with a sling procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 hours after surgery while patient is in post-anesthesia care unit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 hours after surgery while patient is in post-anesthesia care unit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 hours after surgery while patient is in post-anesthesia care unit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tamsulosin Effect

Secondary outcome measures

Effect of Tamsulosin on postoperative blood pressure

Postoperative Narcotic Use

Side effects data

From 2013 Phase 4 trial • 742 Patients • NCT01294592

Retrograde ejaculation

Respiratory tract infection

Colon cancer

Atrial fibrillation

Diverticulitis

Prostate cancer

Prostatitis

Erectile dysfunction

100%

80%

60%

40%

20%

Study treatment Arm

Watchful Waiting All: Escalated Yes and No

Dutasteride Plus Tamsulosin

Watchful Waiting Escalated=Yes

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Preoperative TamsulosinExperimental Treatment1 Intervention

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

Group II: Preoperative PlaceboPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,365,976 Total Patients Enrolled

4 Trials studying Urinary Retention

881 Patients Enrolled for Urinary Retention

Media Library

Tamsulosin 0.4Mg Capsule (Alpha-1 Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04232683 — Phase < 1

Urinary Retention Research Study Groups: Preoperative Tamsulosin, Preoperative Placebo

Urinary Retention Clinical Trial 2023: Tamsulosin 0.4Mg Capsule Highlights & Side Effects. Trial Name: NCT04232683 — Phase < 1

Tamsulosin 0.4Mg Capsule (Alpha-1 Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04232683 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants for this research endeavor?

"Participants are not being sought for this clinical trial at present. The study was initially advertised on 18th December 2019 and had its last edit on 5th October 2022. If you're seeking alternative trials, there currently exist 53 research studies actively recruiting patients with pelvic floor disorders and 13 investigations searching for participants to test preoperative tamsulosin."

Answered by AI

What past research has been conducted concerning the efficacy of Preoperative Tamsulosin?

"Currently, 13 different research initiatives are analyzing the efficacy of preoperative tamsulosin. Of these studies 3 have reached phase three and many take place in Baden Aargau. Nonetheless, across the world there are still a total of thirteen sites running trials for this drug."

Answered by AI

Is the recruitment of participants still in progress for this investigation?

"As of October 5th 2022, the clinical trial has ceased recruitment. Originally posted on December 18th 2019, this study is currently closed to new patients. Other studies that may be relevant include 53 trials actively enrolling participants with pelvic floor disorders and 13 studies for Preoperative Tamsulosin recruiting individuals."

Answered by AI