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Inadequate patient recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrofurantoin | Drug | nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 to 8 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks after surgery |
| Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Sutkin, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
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This is a double blind 1:1 randomized trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Nitrofurantoin Group | extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC |
| FG001 | Arm 2: Placebo Group | identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is a randomized, double-blind, placebo-controlled clinical trial
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Nitrofurantoin Group | extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC |
| BG001 | Arm 2: Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | 6 to 8 weeks after surgery |
|
Data was collected from the point of surgery up to a period of 6 to 8 weeks post surgery and completion of CISC (Clean Intermittent Self-catheterization)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Nitrofurantoin Group | extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC |
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Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Sutkin, MD | University of Pittsburgh, UPP13 WH Uro Gynecology - Cor | 412--641-1440 | gsutkin@mail.magee.edu |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009582 | Nitrofurantoin |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
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|
| Placebo | Drug | Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping 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. |
| 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. | 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. | 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. | 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. | 6 weeks after surgery |
identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Arm 2: Placebo Group |
identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC |
|
| Secondary | 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. | 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. | Posted | 6 weeks after surgery |
|
|
| Secondary | 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. | 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. | Posted | 6 weeks after surgery |
|
|
| Secondary | 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. | 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. | Posted | 6 weeks after surgery |
|
|
| Secondary | 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. | Posted | 6 weeks after surgery |
|
|
| Secondary | 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. | 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. | Posted | 6 weeks after surgery |
|
|
| Secondary | 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. | 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. | Posted | 6 weeks after surgery |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Arm 2: Placebo Group | identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC | 0 | 5 | 0 | 5 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |