Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain
Status:
Terminated
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
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.