Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain

NCT01189071 | Terminated Results

• 1 other identifier: IRB 1119697
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized two arm prospective study to evaluate postoperative ureteral stent pain. One arm will be given 3 days of preoperative darifenacin and the control group will have the standard of care which is no preoperative anticholinergic medication. The primary endpoints will be decreased pain scores and less ER visits and hospital admissions for stent difficulty. These will be assessed by a pain diary completed by the participant as well as a questionnaire when the participant returns to clinic for stent removal. Also included in evaluation of the primary end point will be patient phone calls, ER visits and admissions for stent difficulty. Secondary endpoints will be narcotic and postoperative anticholinergic use. This will also be assessed with the pain diary completed by the participant. Participants will be included in the study if they are undergoing a procedure that a stent will likely be required. This will include participants who will have ureteroscopy or extracorporeal shock wave lithotripsy and a stone 1 cm or larger. Also participants with stones smaller than 1 cm who due to anatomy of the ureter or kidney will likely need a stent on preoperative evaluation will also be included in the study. Included as well in the study are participants who will undergo renal or ureteral surgery that a ureteral stent will be utilized. Participants will be randomized after consent is obtained into two groups. One group will receive standard of care which is no preoperative anticholinergic medications. The second group will receive the three day treatment with darifenacin pre procedure. Participants in the second group will be instructed on side effects of darifenacin and given appropriate contact information prior to initiation of the medication. Both groups will be followed postoperatively with a pain diary. Postoperative follow up will continue until the stent is removed 1-2 weeks after the procedure. The exact time of stent removal will depend on the success and nature of the surgery and will be at the discretion of the surgeon. Participants will be able to voluntarily stop the medication for any reason as well as if they have serious side effects from the medication. Data to be collected from each group includes age, gender, race, prior ureteral stents, prior renal or ureteral surgery, past medical history, allergies, current medications and urinary complaints.

Conditions

Overactive Bladder; Renal Colic; Pain, Postoperative

Keywords

Stents [E07.695.750]; Darifenacin (C101207); Kidney calculi

Outcome Measures

Primary Outcomes (1)

• Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty

  Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the "standard of care" patient with no preop Darifenacin

  24 months

Secondary Outcomes (1)

• Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.

  end of study with 30 patients recruited

Study Arms (2)

Darifenacin

ACTIVE COMPARATOR

3 days of preoperative darifenacin anticholinergic medication

Drug: Darifenacin

no pill

NO INTERVENTION

The control group will have the standard of care which is no preoperative anticholinegic medication.

Interventions

Darifenacin DRUG

an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery.

Also known as: Enablex

Darifenacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included in the study if they are undergoing a procedure that a stent will likely be required. This will include participants who will have ureteroscopy or extracorporeal shock wave lithotripsy and a stone 1 cm or larger.
• Also participants with stones smaller than 1 cm who due to anatomy of the ureter or kidney will likely need a stent on preoperative evaluation will also be included in the study.
• Included as well in the study are participants who will undergo renal or ureteral surgery that a ureteral stent will be utilized.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Healthcare

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Renal Colic; Pain, Postoperative; Kidney Calculi

Interventions

darifenacin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Nephrolithiasis; Kidney Diseases; Urolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical

Limitations and Caveats

Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.

Results Point of Contact

• Title: Dr. Mark Wakefield
• Organization: University of Missouri-Columbia

wakefieldmr@health.nissouri.edu

573-882-0496

Study Officials

• Mark R Wakefield, MD

  University of Missouri Healthcare, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 26, 2010
• Study Start: August 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 21, 2016
• Results First Posted: November 21, 2016

Record last verified: 2016-09

Locations

US (1)