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

University of Missouri (MU)

Status and phase: Completed; Phase 4

Conditions: Stress Incontinence

Treatments: Other: Placebo; Drug: Nitrofurantoin

Study type: Interventional

Funder types: Other

Identifiers

NCT00734968

1108717

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 161 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively

Treatment:

Drug: Nitrofurantoin

Placebo

Placebo Comparator group

Description:

Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)

Treatment:

Other: Placebo