Urinary Tract InfectionsAPPICNCT00678041
Nitrofurantoin and Urinary Tract Infections (UTIs)
A study testing Nitrofurantoin in people with Urinary Tract Infections, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Nitrofurantoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital
Who cannot join
- 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)).
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial Examining the Effect of Nitrofurantoin Prophylaxis in Women Performing Clean Intermittent Self-catheterization (CISC) After Surgery for Urinary Incontinence and/or Pelvic Organ Prolapse
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.
Read the detailed description
Abstract:
Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo.
Study Design: Randomized double-blind placebo-controlled trial.
Methods: Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC.
Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test.
Sample Size: Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.
- Conditions
- Urinary Tract Infections
- Being tested
- Nitrofurantoin, Placebo
- Keywords
- urinary catheterization, urinary tract infection, urinary incontinence, pelvic floor prolapse, antibiotics
- Medical subject headings
- Urinary Tract Infections, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrofurantoinDrug
Also called Macrodantin
nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
PlaceboDrug
Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Nitrofurantoin Group | Experimental | extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC Receives: Drug: Nitrofurantoin |
| Arm 2: Placebo Group | Placebo comparator | identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation
Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.
Measured: 6 to 8 weeks after surgery
Secondary outcomes (6)
Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI
0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Measured: 6 weeks after surgery
Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.
0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Measured: 6 weeks after surgery
Adherence to CISC
0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Measured: 6 weeks after surgery
Patient Perceptions Regarding CISC
0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Measured: 6 weeks after surgery
Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria
0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Measured: 6 weeks after surgery
Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis
0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Inadequate patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Sutkin, University of Pittsburgh
- Investigators
- Gary Sutkin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678041
- Sponsor's protocol ID
- SutkinAppic
- Acronym
- APPIC
- Status last verified
- Aug 2016
- First submitted
- 10 May 2008
- Last updated
- 27 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial Examining the Effect of Nitrofurantoin Prophylaxis in Women Performing Clean Intermittent Self-catheterization (CISC) After Surgery for Urinary Incontinence and/or Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT00678041
- Acronym / sponsor ID
- APPIC / SutkinAppic
- Conditions
- Urinary Tract Infections
- Keywords
- urinary catheterization, urinary tract infection, urinary incontinence, pelvic floor prolapse, antibiotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate patient recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 2 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Abstract:
Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo.
Study Design: Randomized double-blind placebo-controlled trial.
Methods: Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC.
Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test.
Sample Size: Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Nitrofurantoin Group | Experimental | Drug: Nitrofurantoinextended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC |
| Arm 2: Placebo Group | Placebo comparator | Drug: Placeboidentical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitrofurantoinAlso: Macrodantinnitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC | Drug | Arm 1: Nitrofurantoin Group |
| PlaceboPlacebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC | Drug | Arm 2: Placebo Group |
Primary outcome
Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation
Time frame: 6 to 8 weeks after surgery
Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.
6 secondary outcomes
Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI
Time frame: 6 weeks after surgery
Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.
Time frame: 6 weeks after surgery
Adherence to CISC
Time frame: 6 weeks after surgery
Patient Perceptions Regarding CISC
Time frame: 6 weeks after surgery
Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria
Time frame: 6 weeks after surgery
Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis
Time frame: 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Sutkin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrofurantoin in people with Urinary Tract Infections, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation (time frame: 6 to 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.