NCT06810687

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Jan 2025Jan 2028

Study Start

First participant enrolled

January 30, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

January 31, 2025

Last Update Submit

February 5, 2025

Conditions

Urinary Tract Infection (Diagnosis)

Keywords

urinary tract infectionmidurethral slingprophylaxismethenamine

Outcome Measures

Primary Outcomes (1)

  • Incidence of urinary tract infection

    Urinary tract infection (Positive urine culture) within 6 weeks post-operatively after completing 3 days of antibiotics or methenamine

    Within 6 weeks after the procedure

Secondary Outcomes (2)

  • Number of participants with adverse effects

    within 6 weeks after the procedure

  • Occurrence of additional treatment of UTI

    Within 6 weeks after the procedure

Study Arms (2)

Methenamine prophylaxis

EXPERIMENTAL

Methenamine will be prescribed for urinary tract infection prophylaxis

Drug: Methenamine Hippurate 1g BD

Antibiotic prophylaxis

ACTIVE COMPARATOR

Antibiotic prophylaxis chosen per physician preference

Other: Antibiotic prophylaxis

Interventions

Methenamine Hippurate 1g BDDRUG

Antibiotic prophylaxis

Methenamine prophylaxis
Antibiotic prophylaxisOTHER

Antibiotic prophylaxis

Antibiotic prophylaxis

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age ≥ 18
  • Patients undergoing mid-urethral sling procedure

You may not qualify if:

  • Medication intolerance or allergy to study medications
  • Renal impairment with GFR \<30
  • Breast feeding
  • Pregnancy
  • Recurrent urinary tract infections
  • Active urinary tract infection
  • Immunosuppressive disease
  • Interstitial cystitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health

Morristown, New Jersey, 07928, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract InfectionsDisease

Interventions

methenamine hippurateAntibiotic Prophylaxis

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChemopreventionDrug TherapyTherapeuticsPremedication

Central Study Contacts

Rena Ow, MD

CONTACT

9739717267rena.ow@atlantichealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 5, 2025

Study Start

January 30, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

February 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)