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Trial Outcomes & Findings for Nitrofurantoin and Urinary Tract Infections (UTIs) (NCT NCT00678041)

NCT ID: NCT00678041

Last Updated: 2016-09-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 to 8 weeks after surgery

Results posted on

2016-09-27

Participant Flow

This is a double blind 1:1 randomized trial

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
5
5
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
5
5

Reasons for withdrawal

Reasons for withdrawal
Measure
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
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
Overall Study
Physician Decision
5
5

Baseline Characteristics

Nitrofurantoin and Urinary Tract Infections (UTIs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1: Nitrofurantoin Group
n=5 Participants
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
Arm 2: Placebo Group
n=5 Participants
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
Total
n=10 Participants
Total of all reporting groups
Age, Customized
at least 18 yrs of age
5 participants
n=99 Participants
5 participants
n=107 Participants
10 participants
n=206 Participants
Sex/Gender, Customized
Female
5 participants
n=99 Participants
5 participants
n=107 Participants
10 participants
n=206 Participants
Sex/Gender, Customized
Male
0 participants
n=99 Participants
0 participants
n=107 Participants
0 participants
n=206 Participants

PRIMARY outcome

Timeframe: 6 to 8 weeks after surgery

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks after surgery

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Nitrofurantoin Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 2: Placebo Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary Sutkin, MD

University of Pittsburgh, UPP13 WH Uro Gynecology - Cor

Phone: 412--641-1440

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place