Trial Outcomes & Findings for Effect of Phenazopyridine on Prolapse Surgery Voiding Trials (NCT NCT03065075)

NCT ID: NCT03065075

Last Updated: 2019-04-16

Results Overview

Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 152 participants
• Primary outcome timeframe: postoperative day 1
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	Phenazopyridine on POD1 Participant is given Phenazopyridine 200 mg on postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis: * 1 had a bowel injury re-operation that precluded performing a void trial * 1 intraoperative cystotomy that precluded performing a void trial * 2 were using Foley catheters preoperatively, which was part of the exclusion criteria 72 subjects in the intent-to-treat analysis 3 did not receive the intervention: * 1 was too nauseous * 1 was erroneously missed * 1 refused 69 subjects in the as-treated analysis	No Intervention on POD1 Subject is not given Phenazopyridine on postoperative day 1 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis: * 1 intraoperative cystotomy that precluded performing a void trial * 1 had spinal anesthesia, which was part of the exclusion criteria 74 subjects in the intent-to-treat analysis 3 cross-overs were brought in from the intervention arm because they did not receive the medication 77 subjects in the as-treated analysis
Overall Study STARTED	76	76
Overall Study Intent-to-treat Analysis	72	74
Overall Study As-treated Analysis	69	77
Overall Study COMPLETED	76	76
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Baseline characteristics by cohort

Measure	Phenazopyridine n=76 Participants Participant is given Phenazopyridine on morning of postoperative day 1	No Phenazopyridine n=76 Participants Participant is not given Phenazopyridine on morning of postoperative day 1	Total n=152 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 12.8 • n=5 Participants	60.9 years STANDARD_DEVIATION 13.5 • n=7 Participants	61.2 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	76 Participants n=7 Participants	152 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 White	61 Participants n=5 Participants	59 Participants n=7 Participants	120 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Declined to answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Concomitant hysterectomy	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: postoperative day 1

Population: Intent-to-treat analysis

Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.

Outcome measures

Measure	Phenazopyridine n=72 Participants Participant is given Phenazopyridine on morning of postoperative day 1	No Phenazopyridine n=74 Participants Participant is not given Phenazopyridine on morning of postoperative day 1
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)	30 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day 1

Population: As-treated analysis

Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.

Outcome measures

Measure	Phenazopyridine n=69 Participants Participant is given Phenazopyridine on morning of postoperative day 1	No Phenazopyridine n=77 Participants Participant is not given Phenazopyridine on morning of postoperative day 1
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED)	28 Participants	27 Participants

Adverse Events

Phenazopyridine

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

No Phenazopyridine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phenazopyridine n=76 participants at risk Participant is given Phenazopyridine Phenazopyridine: Phenazopyridine on morning of postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis: * 1 had a bowel injury re-operation that precluded performing a void trial * 1 intraoperative cystotomy that precluded performing a void trial * 2 were using Foley catheters preoperatively, which was part of the exclusion criteria 72 subjects in the intent-to-treat analysis 3 did not receive the intervention: * 1 was too nauseous * 1 was erroneously missed * 1 refused 69 subjects in the as-treated analysis	No Phenazopyridine n=76 participants at risk Participant is not given Phenazopyridine 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis: * 1 intraoperative cystotomy that precluded performing a void trial * 1 had spinal anesthesia, which was part of the exclusion criteria 74 subjects in the intent-to-treat analysis 3 cross-overs were brought in from the intervention arm because they did not receive the medication 77 subjects in the as-treated analysis
Gastrointestinal disorders Bowel injury re-operation	1.3% 1/76 • Number of events 1 • 6 weeks	0.00% 0/76 • 6 weeks

Other adverse events

Measure	Phenazopyridine n=76 participants at risk Participant is given Phenazopyridine Phenazopyridine: Phenazopyridine on morning of postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis: * 1 had a bowel injury re-operation that precluded performing a void trial * 1 intraoperative cystotomy that precluded performing a void trial * 2 were using Foley catheters preoperatively, which was part of the exclusion criteria 72 subjects in the intent-to-treat analysis 3 did not receive the intervention: * 1 was too nauseous * 1 was erroneously missed * 1 refused 69 subjects in the as-treated analysis	No Phenazopyridine n=76 participants at risk Participant is not given Phenazopyridine 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis: * 1 intraoperative cystotomy that precluded performing a void trial * 1 had spinal anesthesia, which was part of the exclusion criteria 74 subjects in the intent-to-treat analysis 3 cross-overs were brought in from the intervention arm because they did not receive the medication 77 subjects in the as-treated analysis
Infections and infestations Urinary tract infection	11.8% 9/76 • Number of events 9 • 6 weeks	18.4% 14/76 • Number of events 14 • 6 weeks

Additional Information

Dr. Tania Sierra

University of Massachusetts

Phone: 508-334-9840

Email: tania.sierra@umassmemorial.org

Results disclosure agreements

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