Trial Outcomes & Findings for Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery (NCT NCT02727322)

Last Updated: 2019-05-29

Results Overview

Frequency of symptomatic, culture-proven UTI; included participants who were empirically treated outside of protocol (symptoms but no culture) within 6 weeks of surgery. Positive culture was defined as at least 100,000 colony forming units (cfu)/ml of uropathic bacteria in a catheterized or midstream clean catch voided urine specimen.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

154 participants

Primary outcome timeframe

within 6 weeks of surgery

Results posted on

2019-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Nitrofurantoin Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use.	Placebo Receives matching placebo Placebo: Patients will receive identical appearing placebo once daily during catheter use.
Overall Study STARTED	77	77
Overall Study COMPLETED	75	76
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nitrofurantoin Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use.	Placebo Receives matching placebo Placebo: Patients will receive identical appearing placebo once daily during catheter use.
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrofurantoin n=75 Participants Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use.	Placebo n=76 Participants Receives matching placebo Placebo: Patients will receive identical appearing placebo once daily during catheter use.	Total n=151 Participants Total of all reporting groups
Preoperative POP-Q Stage 4	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 11.9 • n=5 Participants	60.5 years STANDARD_DEVIATION 12.0 • n=7 Participants	60.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	76 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	64 participants n=5 Participants	60 participants n=7 Participants	124 participants n=5 Participants
Race/Ethnicity, Customized African American	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Native American	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Body Mass Index (kg/m^2)	26.8 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants	27.5 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	27.2 kg/m^2 STANDARD_DEVIATION 5.1 • n=5 Participants
Gravidity	3 number of pregnancies STANDARD_DEVIATION 2 • n=5 Participants	3 number of pregnancies STANDARD_DEVIATION 2 • n=7 Participants	3 number of pregnancies STANDARD_DEVIATION 2 • n=5 Participants
Parity	3 pregnancies delivered after 20 weeks STANDARD_DEVIATION 1 • n=5 Participants	3 pregnancies delivered after 20 weeks STANDARD_DEVIATION 1 • n=7 Participants	3 pregnancies delivered after 20 weeks STANDARD_DEVIATION 1 • n=5 Participants
Current Smoker	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Menopausal Status Premenopausal	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Menopausal Status Postmenopausal, No Hormone Replacement therapy	56 Participants n=5 Participants	57 Participants n=7 Participants	113 Participants n=5 Participants
Menopausal Status Postmenopausal, Oral Hormone Replacement Therapy	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Vaginal Estrogen Use	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Diabetes, on medication	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
History of Urinary Tract Infection in past year	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Preoperative POP-Q Stage 0	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Preoperative POP-Q Stage 1	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Preoperative POP-Q Stage 2	27 Participants n=5 Participants	16 Participants n=7 Participants	43 Participants n=5 Participants
Preoperative POP-Q Stage 3	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Preoperative POP-Q Stage unknown	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Preoperative Postvoid Residual Volume	87.4 ml STANDARD_DEVIATION 147.5 • n=5 Participants	66.4 ml STANDARD_DEVIATION 129.4 • n=7 Participants	72.8 ml STANDARD_DEVIATION 95.3 • n=5 Participants
Indication for surgery Prolapse	38 Participants n=5 Participants	31 Participants n=7 Participants	69 Participants n=5 Participants
Indication for surgery Incontinence	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Indication for surgery Prolapse and Incontinence	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 6 weeks of surgery

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=75 Participants Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheterization.	Placebo n=76 Participants Receives matching placebo Placebo: Patients will receive identical appearing placebo daily during catheterization.
Number of Participants Experiencing Urinary Tract Infection Within 6 Weeks of Surgery	13 Participants	13 Participants

SECONDARY outcome

Timeframe: within 6 weeks of surgery

This is the number of participants who experienced at least one adverse symptom as reported on the diary completed daily while requiring catheterization. These adverse symptoms included: constipation, nausea/vomiting, drowsiness, headache, flatulence, abdominal pain, dizziness, diarrhea, rash/itching, dyspepsia, fever/chills, amblyopia and other.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=75 Participants Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheterization.	Placebo n=76 Participants Receives matching placebo Placebo: Patients will receive identical appearing placebo daily during catheterization.
Number of Participants Who Experienced at Least One Adverse Event Symptom While Requiring Catheterization	51 Participants	46 Participants

SECONDARY outcome

Timeframe: within 6 weeks of surgery

Frequency of urine cultures with one or more organisms resistant to nitrofurantoin. Positive culture was defined as at least 100,000 colony forming units (cfu)/ml of uropathic bacteria in a catheterized or midstream clean catch voided urine specimen.

Outcome measures

Outcome measures
Measure	Nitrofurantoin n=12 Positive urine cultures Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheterization.	Placebo n=15 Positive urine cultures Receives matching placebo Placebo: Patients will receive identical appearing placebo daily during catheterization.
Frequency of Urine Cultures Positive for Nitrofurantoin-resistant Isolates	4 nitrofurantoin resistant urine cultures	3 nitrofurantoin resistant urine cultures

Adverse Events

Nitrofurantoin

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nitrofurantoin n=75 participants at risk Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use.	Placebo n=76 participants at risk Receives matching placebo Placebo: Patients will receive identical appearing placebo once daily during catheter use.
Vascular disorders Transient Ischemic Attack	0.00% 0/75 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Blood and lymphatic system disorders Transfusion	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	0.00% 0/76 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Renal and urinary disorders Voiding Dysfunction Requiring Surgery	2.7% 2/75 • Number of events 2 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.

Other adverse events

Other adverse events
Measure	Nitrofurantoin n=75 participants at risk Receives once daily nitrofurantoin 100mg Nitrofurantoin: Patients will receive nitrofurantoin 100mg once daily during catheter use.	Placebo n=76 participants at risk Receives matching placebo Placebo: Patients will receive identical appearing placebo once daily during catheter use.
Nervous system disorders Headache	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Nervous system disorders Lower Extremity Symptoms	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	0.00% 0/76 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Blood and lymphatic system disorders Anemia	0.00% 0/75 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Gastrointestinal disorders Nausea	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Skin and subcutaneous tissue disorders Rash	4.0% 3/75 • Number of events 3 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	2.6% 2/76 • Number of events 2 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Renal and urinary disorders Dysuria	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	2.6% 2/76 • Number of events 2 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Renal and urinary disorders Hematuria	4.0% 3/75 • Number of events 3 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Renal and urinary disorders Prolonged Urinary Retention	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	2.6% 2/76 • Number of events 2 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Renal and urinary disorders Catheter Discomfort or Obstruction	4.0% 3/75 • Number of events 3 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	0.00% 0/76 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Renal and urinary disorders Hydronephrosis	0.00% 0/75 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	1.3% 1/76 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Infections and infestations Infection of Incision	2.7% 2/75 • Number of events 2 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	3.9% 3/76 • Number of events 3 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Infections and infestations Vulvovaginal Yeast Infection	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	0.00% 0/76 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
Infections and infestations Infected Hematoma	1.3% 1/75 • Number of events 1 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	0.00% 0/76 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.
General disorders	0.00% 0/75 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.	2.6% 2/76 • Number of events 2 • 6 weeks since randomization Participants completed daily diaries during catheterization in which they reported adverse effects. Study coordinators also solicited adverse events from participants at 6 weeks, and reviewed medical records for adverse events.

Additional Information

Halina Zyczynski

University of Pittsburgh

Phone: 421-641-1440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place