Overactive BladderNCT01189071
Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain
A study testing Darifenacin in people with Overactive Bladder and Renal Colic, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Renal Colic, Pain, Postoperative
- What is being tested?
- Darifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who do not meet inclusion criteria-
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Healthcare
Columbia, Missouri, 65212
About this study
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.
Read the detailed description
The purpose of the study is to determine if preoperative dosing of darifenacin will assist in postoperative ureteral stent pain. 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 anticholinegic 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
- Being tested
- Darifenacin
- Keywords
- Stents [E07.695.750], Darifenacin (C101207), Kidney calculi
- Medical subject headings
- Urinary Bladder, Overactive, Renal Colic, Pain, Postoperative, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarifenacinDrug
Also called Enablex
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.
| Study group | Role | What they receive |
|---|---|---|
| Darifenacin | Active comparator | 3 days of preoperative darifenacin anticholinergic medication Receives: Drug: Darifenacin |
| no pill | No intervention | The control group will have the standard of care which is no preoperative anticholinegic medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.
Decreased use of narcotic and anticholinergic medication use postoperatively, compared to the "standard of care" patient
Measured: end of study with 30 patients recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Co-Investigator left institution. No data analysis occurred.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark R Wakefield, MD, Principal investigator, University of Missouri Healthcare, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189071
- Sponsor's protocol ID
- IRB 1119697
- Status last verified
- Sep 2016
- First submitted
- 19 Aug 2010
- Last updated
- 21 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain
- ClinicalTrials.gov ID
- NCT01189071
- Acronym / sponsor ID
- IRB 1119697
- Conditions
- Overactive Bladder, Renal Colic, Pain, Postoperative
- Keywords
- Stents [E07.695.750], Darifenacin (C101207), Kidney calculi
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Co-Investigator left institution. No data analysis occurred.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to determine if preoperative dosing of darifenacin will assist in postoperative ureteral stent pain. 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 anticholinegic 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darifenacin | Active comparator | Drug: Darifenacin3 days of preoperative darifenacin anticholinergic medication |
| no pill | No intervention | –The control group will have the standard of care which is no preoperative anticholinegic medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarifenacinAlso: Enablexan 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. | Drug | Darifenacin |
Primary outcome
Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty
Time frame: 24 months
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
1 secondary outcome
Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.
Time frame: end of study with 30 patients recruited
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R Wakefield, MD principal investigator
University of Missouri Healthcare, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Darifenacin in people with Overactive Bladder and Renal Colic, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.