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NCT06810687 · ClinicalTrials.gov registry record · NA

Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?

A NA study of Urinary Tract Infection (Diagnosis), sponsored by Atlantic Health System.

Recruiting
Registry status
NA
Development phase
190
Enrollment target
1
Study location

NCT06810687 is a NA study of Urinary Tract Infection (Diagnosis) that is actively recruiting participants, run by Atlantic Health System. The registered enrollment target is 190 participants, below the 369-participant average among 4 other Urinary Tract Infection (Diagnosis) trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06810687, a NA study of Urinary Tract Infection (Diagnosis), is actively recruiting participants, sponsored by Atlantic Health System.

RECRUITING
Registry status
NA
Development phase
190 participants
Enrollment target
1
Study location

Study Summary

Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies have demonstrated that MUS placement can increase the risk of UTI up to 21-34%. Post-operative UTI can lead to significant healthcare and patient burden. This additional burden further contributes to an estimated annual cost of $1.6 billion for UTI management in the United States. With increased antibiotic usage, there is simultaneous increase in bacterial resistance leading to treatment refractory UTI. The investigators prescribe post-operative antibiotics prophylactically for 3 days after MUS placement with or without concurrent pelvic reconstructive surgery based on prior literature recommending post-operative prophylaxis. There is a greater emphasis on limiting antibiotic use given the trend of development of bacterial resistance. There are studies supporting alternatives such as methenamine for recurrent UTI prophylaxis treatment, but there are limited studies evaluating methenamine for UTI prophylaxis after MUS.

Interventions

  • DRUG Methenamine Hippurate 1g BD
  • OTHER Antibiotic prophylaxis

Study Locations (1)

New Jersey

  • Atlantic Health - Morristown

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2025-01-30
Est. Completion 2028-01-30
Phase NA

Sponsor

Atlantic Health System

43 total trials

What the Registry Record Tells You About NCT06810687

The ClinicalTrials.gov registry entry for NCT06810687 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 369-participant average among 4 other Urinary Tract Infection (Diagnosis) trials with a reported enrollment target (49% lower). The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urinary Tract Infection (Diagnosis) appearing as the primary indexed condition, and to 2 interventions - of which Methenamine Hippurate 1g BD is the first listed.

NCT06810687 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT06810687 about?

NCT06810687 is a clinical study titled "Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?". Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies ha...

What is the current status of trial NCT06810687?

This trial is currently recruiting. It is a NA study. The enrollment target is 190 participants. The study started on 2025-01-30. Estimated completion is 2028-01-30.

What conditions does trial NCT06810687 study?

This clinical trial studies the following conditions: Urinary Tract Infection (Diagnosis).

What interventions are being tested in trial NCT06810687?

The interventions under investigation include: Methenamine Hippurate 1g BD (DRUG), Antibiotic prophylaxis (OTHER).

Who is sponsoring clinical trial NCT06810687?

This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06810687 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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