Assessing Pyridium for Post-Sling Urinary Retention

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT03302936
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.2
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Drug: Phenazopyridine	Phase 4

Detailed Description

This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
• Actual Study Start Date: Oct 24, 2017
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyridium arm Phenazopyridine 200mg tablet, once prior to surgery	Drug: Phenazopyridine; to be given preoperatively; Other Names: Pyridium
No Intervention: Control arm No intervention in this group. Routine perioperative care.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Considered to Have Passed Their Voiding Trial [Day 1]

   Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.

2. Incidence of Urinary Retention [Day 1]

   Incidence of participants that do not pass their voiding trial and go home with an indwelling foley

Secondary Outcome Measures

1. Pain Scale [Day 1: 6-8 hours after surgery]

   Pain scale from 0-10. 0-being no pain, 10-being the most pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery

Exclusion Criteria:

• Patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring indwelling catheter

• Acute bleeding requiring indwelling catheter for accurate urine output calculation

• Patients undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid residual >150cc, or spinal anesthesia

• Women who are pregnant, including women of childbearing age who test positive on preoperative urine pregnancy test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Charles Ascher-Walsh, M.D., Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 28, 2017

More Information

Publications

None provided.

• Responsible Party: Annacecilia Peacher, Associate Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03302936
• Other Study ID Numbers: GCO 17-0999
• First Posted: Oct 5, 2017
• Last Update Posted: Oct 29, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Annacecilia Peacher, Associate Professor, Icahn School of Medicine at Mount Sinai: Midurethral sling; Pyridium
• Additional relevant MeSH terms: Urinary Retention

Study Results

Participant Flow

Arm/Group Title	Pyridium Arm	Control Arm Vitamin B-6 as Placebo
Arm/Group Description	Phenazopyridine 200mg tablet, once prior to surgery Phenazopyridine: to be given preoperatively	Vitamin B-6 50mg given once prior to surgery as placebo. Routine perioperative care.
Period Title: Overall Study
STARTED	49	49
COMPLETED	46	45
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Pyridium Arm	Control Arm	Total
Arm/Group Description	Phenazopyridine 200mg tablet, once prior to surgery Phenazopyridine: to be given preoperatively	No intervention in this group. Routine perioperative care.	Total of all reporting groups
Overall Participants	46	45	91
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 73.9%	29 64.4%	63 69.2%
>=65 years	12 26.1%	16 35.6%	28 30.8%
Sex: Female, Male (Count of Participants)
Female	46 100%	45 100%	91 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 32.6%	13 28.9%	28 30.8%
Not Hispanic or Latino	31 67.4%	32 71.1%	63 69.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.2%	3 6.7%	4 4.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2.2%	5 11.1%	6 6.6%
White	29 63%	24 53.3%	53 58.2%
More than one race	15 32.6%	13 28.9%	28 30.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	46 100%	45 100%	91 100%
Menopausal status (Count of Participants)
Count of Participants [Participants]	22 47.8%	28 62.2%	50 54.9%
Tobacco user (Count of Participants)
Count of Participants [Participants]	7 15.2%	0 0%	7 7.7%
History of abdominal or pelvic surgery (Count of Participants)
Count of Participants [Participants]	13 28.3%	9 20%	22 24.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Considered to Have Passed Their Voiding Trial
Description	Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pyridium Arm	Control Arm
Arm/Group Description	Phenazopyridine 200mg tablet, once prior to surgery Phenazopyridine: to be given preoperatively Failed void trial, 16 participants or 34.5% in the phenazopyridine arm.	Vitamin B-6 as placebo. Routine perioperative care. Failed void trial, 15 participants or 33.3% in the placebo arm.
Measure Participants	46	45
Count of Participants [Participants]	30 65.2%	30 66.7%

2. Primary Outcome

Title	Incidence of Urinary Retention
Description	Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urinary Retention in Pyridium	Urinary Retention in Placebo
Arm/Group Description	Urinary retention is the same value as failed void trial in both arms	Urinary retention is the same value as failed void trial
Measure Participants	46	45
Count of Participants [Participants]	16 34.8%	15 33.3%

3. Secondary Outcome

Title	Pain Scale
Description	Pain scale from 0-10. 0-being no pain, 10-being the most pain
Time Frame	Day 1: 6-8 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Scale in Pyridium Arm	Pain Scale in Placebo Arm
Arm/Group Description	At time of void, pain on a VAS scale from 0-10	At time of void pain on a VAS scale from 0-10
Measure Participants	46	45
Median (Inter-Quartile Range) [score on a scale]	3	3

Adverse Events

Time Frame	Through day of surgery
Arm/Group Title	Pyridium		Placebo
Arm/Group Description	Phenazopyridine 200mg tablet, once prior to surgery		Vitamin B-6 50mg given once prior to surgery as placebo.
All Cause Mortality
	Pyridium		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)
Serious Adverse Events
	Pyridium		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Pyridium		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.