TerminatedNot Applicable

Nitrofurantoin and Urinary Tract Infections (UTIs)

Stopped: Inadequate patient recruitment

United States10 participantsStarted 2008-05

Plain-language summary

Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects. This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital Exclusion Criteria: * Known drug allergy to nitrofurantoin * A history of renal insufficiency * Renal transplant * Renal nephropathy * A recent history of more than 3 Urinary Tract Infections (UTIs) per year * Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation

Timeframe: 6 to 8 weeks after surgery

Trial details

NCT IDNCT00678041

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-05

Results submitted2016-05-10

View on ClinicalTrials.gov More Urinary Tract Infections trials