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Completed

NCT Number: NCT00734968

Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence

This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

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Key information

Conditions

Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Tract Infections Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Scott and White Hosptial, Texas A&M University

Temple, Texas, 76508, United States

About this study

This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Exclusion criteria

  • Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).

Treatment and study plan

Nitrofurantoin

Drug

Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Other names: Macrobid

Placebo

Other

6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.

Primary outcomes

  1. Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence

    Time frame: 6 weeks

    The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)

  2. Incidence of Post-operative UTI in Placebo Group

    Time frame: 6 weeks

    The incidence of UTI in the placebo group was 32%.

  3. Incidence of Post-operative UTI in Treatment Group

    Time frame: 6 weeks

    The incidence of UTI in the nitrofurantoin group was 17.6%.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Texas A&M University

Registry information

Official study title

Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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