What side effects are associated with this type of intervention?

Common treatments for urinary retention include the use of bladder scanners, catheterization, and medications such as alpha-blockers. Bladder scanners, which are non-invasive ultrasound devices, have minimal side effects, primarily related to user error or discomfort during the procedure. Catheterization can lead to urinary tract infections, discomfort, and, in rare cases, urethral injury. Medications like alpha-blockers may cause dizziness, fatigue, and hypotension. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for urinary retention, particularly related to benign prostatic hyperplasia (BPH). These include alpha-1-adrenergic antagonists like terazosin and tamsulosin, which help relax the muscles in the prostate and bladder neck to improve urine flow. Additionally, 5-alpha reductase inhibitors such as finasteride are used to shrink the prostate. For patients who do not respond to medication, surgical options like transurethral resection of the prostate (TURP) are available. While non-invasive devices like bladder scanners are used to measure bladder volume and detect urinary retention early, specific FDA approvals for these devices were not detailed in the provided context.

What other types of research exist?

Promising novel alternatives to the Bladder Scanner for urinary retention patients include uroflowmetry and pressure flow studies (PFS). Uroflowmetry is a non-invasive office-based procedure that measures the flow rate of urine, which can help identify obstructions. PFS, although more invasive, provides a detailed assessment of bladder function and can conclusively determine the cause of urinary symptoms. These methods offer valuable diagnostic information that can aid in the early detection and management of urinary retention.

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Evaluating Voiding Trial Volume for Urinary Retention

N/A

Waitlist Available

Led By David Lovejoy, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if patients can urinate on their own after surgery to catch and treat urinary problems early. It aims to prevent complications like bladder damage and infections, improving patient comfort and satisfaction.

Who is the study for?

This trial is for nonpregnant women over 18 who are having surgery for pelvic organ prolapse or urinary incontinence. It's not open to those with preoperative voiding issues requiring self-catheterization, recurrent UTIs, bladder injuries during surgery, intolerance to at least 150cc backfill, neuromuscular disorders, or pregnancy.

What is being tested?

The study is looking at the best volume of fluid to use when testing if patients can urinate properly after urogynecologic surgery. Women will be randomly placed into a control group or a test group to determine this optimal volume.

What are the potential side effects?

While specific side effects aren't detailed here, potential risks may include discomfort from the backfill procedure and symptoms related to urinary retention such as pain or difficulty urinating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

difference in acute voiding dysfunction between a backfill assisted voiding trial

Secondary study objectives

average number of days postoperatively, that require catheterization

proportion of patients developing bladder pain or pressure

proportion of patients developing overactive bladder symptoms

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: control group (voids 2/3 of the volume backfilled)Experimental Treatment1 Intervention

control group

Group II: test group (voids ½ of the total volume backfilled)Active Control1 Intervention

test group)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control Group

2012

Completed Phase 2

~2470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urinary retention include catheterization, pharmacologic treatments, and surgical interventions. Catheterization, either intermittent or indwelling, mechanically drains the bladder to prevent over-distention and potential damage. Pharmacologic treatments, such as alpha-1-adrenergic antagonists, work by relaxing the smooth muscles of the bladder neck and prostate, facilitating easier urine flow. Surgical interventions, like transurethral resection of the prostate (TURP), physically remove obstructions to improve urine flow. These treatments are crucial for urinary retention patients as they help prevent complications like bladder over-distention, ischemia, and long-term voiding dysfunction, thereby improving quality of life and reducing the risk of permanent bladder damage.

Urodynamics of the female lower urinary tract.Percutaneous posterior tibial nerve stimulation as an effective treatment of refractory lower urinary tract symptoms in patients with multiple sclerosis: preliminary data from a multicentre, prospective, open label trial.The role of anticholinergics in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a systematic review and meta-analysis.