NCT02806713

Brief Summary

Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a retropubic midurethral sling operation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

February 5, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

April 29, 2016

Results QC Date

September 5, 2018

Last Update Submit

January 11, 2019

Conditions

Dysfunctional VoidingPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Failed Voiding Trial

    Number of participants with a failed postoperative voiding trial. A failed voiding trial is defined as not voiding all urine in 20 minutes or voiding less than 1/3 of total volume (voided volume + post void residual). Patients will undergo voiding trial at same day surgery per the following protocol. Participants who do not pass the voiding trial the same day of their surgical procedure return to the clinic in 3 days to repeat it, following the same protocol described above.

    Postoperatively, up to 3 days after surgery

Secondary Outcomes (1)

  • Change in Participant-reported Pain From Pre to Post Procedure Using the Visual Analog Scale (VAS)

    Preoperatively and then 2 to 3 hours after surgery

Study Arms (2)

no phenazopyridine

PLACEBO COMPARATOR

Patients not receiving phenazopyridine (standard of care)

Other: no Phenazopyridine

phenazopyridine

EXPERIMENTAL

Patients receiving phenazopyridine

Drug: Phenazopyridine

Interventions

PhenazopyridineDRUG
Also known as: Pyridium
phenazopyridine
no PhenazopyridineOTHER

Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided

no phenazopyridine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Any female subjects scheduled to undergo Mid-Urethral Sling (MUS) through the UMass urogynecology service for incontinence.

You may not qualify if:

  • Planned concurrent prolapse or other procedure besides cystoscopy
  • Using intermittent self catheterization preoperatively
  • Undergoing spinal anesthesia for the procedure
  • Known allergy to phenazopyridine (AKA Pyridium)
  • Renal insufficiency
  • Any condition or situation that in the attending physician's opinion would contra-indicate the use of phenazopyridine
  • Subjects not competent to give consent
  • Prisoners
  • Non-English speaking patients
  • Age \<18
  • Pregnant patients
  • Contraindications to the use of IV methylene blue including
  • Patients with known hypersensitivity reactions
  • Severe renal insufficiency
  • Patients with G6PD deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umass Memorial

Worcester, Massachusetts, 01605, United States

Location

Related Publications (2)

  • Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.

    PMID: 11450979BACKGROUND

  • Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1043-7. doi: 10.1007/s00192-008-0666-z. Epub 2008 Jun 6.

    PMID: 18535753BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Phenazopyridine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminopyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Michael K Flynn
Organization
University of Massachusetts UMass Memorial
michael.flynn@umassmemorial.org
(508) 856-5152

Study Officials

  • Michael K Flynn, MD, MHS

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2016

First Posted

June 21, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

February 5, 2019

Results First Posted

February 5, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)