Ureteropelvic Junction ObstructionPhase 4NCT07911137
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
A Phase 4 study testing Oxybutynin in people with Ureteropelvic Junction Obstruction and Hypospadias, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine whether giving oxybutynin before urologic reconstruction surgery reduces the amount of opioid pain medication needed in children. Oxybutynin is a medication that helps reduce bladder spasms, which can cause pain and discomfort after surgery. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Ureteropelvic Junction Obstruction, Hypospadias
- What is being tested?
- Oxybutynin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children aged 0 to 17 years old admitted for pyeloplasty or hypospadias repair. There is no minimum weight for inclusion
Who cannot join
- Contraindications to anticholinergic medications
- Urinary retention disorders
- Gastrointestinal obstruction/ileus
- Contraindications to anesthetic protocol, including 1) allergy to any anesthetic medication in protocol, 2) refusal of regional technique, 3) contraindications to ketorolac (i.e., recent GI bleed, recent intracranial bleed, renal dysfunction, acute kidney injury)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Alberta Children's Hospital
Calgary, Alberta, T2B6A8
Hayder Al-Kazzaz, 5878976552, hayder.alkazzaz@ucalgary.ca
Bryce Weber
About this study
Official title: A Randomized Double-Blind Placebo-Controlled Trial Evaluating the Opioid-Sparing Effect of Preoperative Oxybutynin in Children Undergoing Urologic Reconstruction
The goal of this clinical trial is to determine whether giving oxybutynin before urologic reconstruction surgery reduces the amount of opioid pain medication needed in children. Oxybutynin is a medication that helps reduce bladder spasms, which can cause pain and discomfort after surgery.
The main question this study aims to answer is:
Does giving oxybutynin before surgery reduce the amount of opioid pain medication children need during the first 6 hours after surgery?
Researchers will compare oxybutynin with a placebo (a tablet containing no active medication) to see whether oxybutynin reduces opioid use after surgery.
Read the detailed description
Background
Children undergoing pediatric urologic reconstruction, such as pyeloplasty and hypospadias repair, frequently require urinary drainage via ureteral stent and/or urethral catheter. These tools cause the bladder to contract involuntarily, mediated by muscarinic receptors (i.e., bladder spasms). This leads to increased catheter-related bladder discomfort (CRBD), bladder spasm-associated pain and postoperative opioid use.
Oxybutynin, an antimuscarinic agent, reduces the occurrence of bladder spasms and thus the number and severity of CRBD events and bladder spasm-related pain. This reduction in discomfort/pain may contribute to decreased postoperative opioid use, as suggested by retrospective pediatric data.
Postoperative management of urologic reconstruction surgeries includes PRN administration of opioids and oxybutynin to treat bladder spasm-related discomfort/pain according to institutional practice and prior pediatric urology literature. Oxybutynin takes 1 hour to reach its maximal plasma concentration, during which time significant bladder spasm-related symptoms may already be present when the child is awake. However, opioids such as morphine achieve their maximal effects within 10 minutes. Because opioids are much faster-acting than oxybutynin, this may increase the likelihood of concomitant administration when the child is awake with discomfort/pain. We are therefore considering using oxybutynin preoperatively, rather than just postoperatively PRN, since its plasma concentration will already be maximal or near-maximal upon waking, which may lead to less CRBD, bladder spasm-related pain, and postoperative opioid use.
This study aims to reduce the use of opioids to treat pediatric patients undergoing urologic reconstruction. Opioids carry significant side effects that include nausea, vomiting, respiratory depression, addiction, urinary retention, tolerance, and constipation. Combined with the ongoing opioid epidemic, there is an increased effort among caregivers, including nurses and physicians, to find other means to reduce pain in pediatric patients.
Opioid therapy has also been shown not to be effective in treating bladder spasm-related symptoms (e.g., CRBD, bladder spasm-related pain). As opposed to opioids, oxybutynin directly targets bladder spasm-associated symptoms, and may reduce the severity of side effects. Side effects of oxybutynin include dry mouth, constipation, dizziness, urinary retention, and blurry vision.
Emerging pediatric urology data suggest that a single preoperative dose may reduce early postoperative opioid requirements. However, current evidence is retrospective and non-randomized. There is no high-quality randomized pediatric study evaluating the opioid sparing effects of preoperative oxybutynin administration in pediatric patients undergoing urologic reconstruction.
Study Need, Importance, and Hypothesis
Urologic reconstruction surgeries requiring a stent and/or catheter can be associated with significant CRBD, bladder-spasm associated pain and morbidity. With the growing recognition of the need to decrease opioid medication, our primary objective is to assess whether the administration of preoperative oxybutynin reduces opioid use. We hypothesize that preoperative oxybutynin reduces early postoperative opioid use in children undergoing pyeloplasty or hypospadias repair.
- Conditions
- Ureteropelvic Junction Obstruction, Hypospadias
- Being tested
- Oxybutynin, Placebo
- Keywords
- Oxybutynin, Opioid-Sparing, Postoperative Opioid Consumption, Pediatric Urology, Urologic Reconstruction, Pyeloplasty, Hypospadias Repair, Bladder Spasms, Catheter-Related Bladder Discomfort, Postoperative Pain
- Medical subject headings
- Multicystic renal dysplasia, bilateral, Hypospadias, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
Participants will receive oxybutynin 0.2 mg/kg (to a maximum dose of 5 mg), orally administered by the day surgery nurse in the day surgery holding area prior to surgery.
PlaceboDrug
Participants will receive a matching placebo tablet, orally administered by the day surgery nurse in the day surgery holding area prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Oxybutynin | Experimental | Participants will receive oxybutynin 0.2 mg/kg (to a maximum dose of 5 mg), orally administered by the day surgery nurse in the day surgery holding area prior to surgery. Receives: Drug: Oxybutynin |
| Preoperative Placebo | Placebo comparator | Participants will receive a matching placebo tablet, orally administered by the day surgery nurse in the day surgery holding area prior to surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cumulative Postoperative Opioid Consumption (MME/kg)
Total cumulative morphine milligram equivalents per kilogram (MME/kg) administered within 6 hours after surgery
Measured: From the end of surgery through 6 hours postoperatively
Secondary outcomes (5)
Proportion of Participants Receiving Postoperative Opioids
Whether any opioid medication was administered within 6 hours after surgery (yes/no)
Measured: From the end of surgery through 6 hours postoperatively
Postoperative Pain Scores (NRS/FLACC)
Pain assessed using age-appropriate validated scales: the Numeric Rating Scale (NRS; 0-10) or the Face, Legs, Activity, Cry, Consolability (FLACC; 0-10) scale. Higher scores indicate greater pain.
Measured: At 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 6 hours following postoperative removal of the laryngeal mask airway or endotracheal tube
Proportion of Participants Receiving Postoperative Rescue Oxybutynin
Whether oxybutynin was administered as needed (PRN) within 6 hours after surgery (yes/no).
Measured: From the end of surgery through 6 hours postoperatively
Total Cumulative Postoperative Oxybutynin Consumption (mg/kg)
Total cumulative dose of oxybutynin administered per kilogram of body weight during the first 6 hours after surgery.
Measured: From the end of surgery through 6 hours postoperatively
Incidence of Adverse Events
Occurrence of adverse events, including dry mouth, flushing, tachycardia, agitation, sedation, and urinary retention.
Measured: From preoperative study medication administration through postoperative discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be stratified by surgery type (pyeloplasty versus hypospadias repair). The sealed envelope software will be used to assign patients to the treatment (preoperative oxybutynin) or control (placebo) group in a 1:1 ratio for both surgeries.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryce Weber, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911137
- Sponsor's protocol ID
- REB26-1464
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo-Controlled Trial Evaluating the Opioid-Sparing Effect of Preoperative Oxybutynin in Children Undergoing Urologic Reconstruction
- ClinicalTrials.gov ID
- NCT07911137
- Acronym / sponsor ID
- REB26-1464
- Conditions
- Ureteropelvic Junction Obstruction, Hypospadias
- Keywords
- Oxybutynin, Opioid-Sparing, Postoperative Opioid Consumption, Pediatric Urology, Urologic Reconstruction, Pyeloplasty, Hypospadias Repair, Bladder Spasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether giving oxybutynin before urologic reconstruction surgery reduces the amount of opioid pain medication needed in children. Oxybutynin is a medication that helps reduce bladder spasms, which can cause pain and discomfort after surgery.
The main question this study aims to answer is:
Does giving oxybutynin before surgery reduce the amount of opioid pain medication children need during the first 6 hours after surgery?
Researchers will compare oxybutynin with a placebo (a tablet containing no active medication) to see whether oxybutynin reduces opioid use after surgery.
Detailed description
Background
Children undergoing pediatric urologic reconstruction, such as pyeloplasty and hypospadias repair, frequently require urinary drainage via ureteral stent and/or urethral catheter. These tools cause the bladder to contract involuntarily, mediated by muscarinic receptors (i.e., bladder spasms). This leads to increased catheter-related bladder discomfort (CRBD), bladder spasm-associated pain and postoperative opioid use.
Oxybutynin, an antimuscarinic agent, reduces the occurrence of bladder spasms and thus the number and severity of CRBD events and bladder spasm-related pain. This reduction in discomfort/pain may contribute to decreased postoperative opioid use, as suggested by retrospective pediatric data.
Postoperative management of urologic reconstruction surgeries includes PRN administration of opioids and oxybutynin to treat bladder spasm-related discomfort/pain according to institutional practice and prior pediatric urology literature. Oxybutynin takes 1 hour to reach its maximal plasma concentration, during which time significant bladder spasm-related symptoms may already be present when the child is awake. However, opioids such as morphine achieve their maximal effects within 10 minutes. Because opioids are much faster-acting than oxybutynin, this may increase the likelihood of concomitant administration when the child is awake with discomfort/pain. We are therefore considering using oxybutynin preoperatively, rather than just postoperatively PRN, since its plasma concentration will already be maximal or near-maximal upon waking, which may lead to less CRBD, bladder spasm-related pain, and postoperative opioid use.
This study aims to reduce the use of opioids to treat pediatric patients undergoing urologic reconstruction. Opioids carry significant side effects that include nausea, vomiting, respiratory depression, addiction, urinary retention, tolerance, and constipation. Combined with the ongoing opioid epidemic, there is an increased effort among caregivers, including nurses and physicians, to find other means to reduce pain in pediatric patients.
Opioid therapy has also been shown not to be effective in treating bladder spasm-related symptoms (e.g., CRBD, bladder spasm-related pain). As opposed to opioids, oxybutynin directly targets bladder spasm-associated symptoms, and may reduce the severity of side effects. Side effects of oxybutynin include dry mouth, constipation, dizziness, urinary retention, and blurry vision.
Emerging pediatric urology data suggest that a single preoperative dose may reduce early postoperative opioid requirements. However, current evidence is retrospective and non-randomized. There is no high-quality randomized pediatric study evaluating the opioid sparing effects of preoperative oxybutynin administration in pediatric patients undergoing urologic reconstruction.
Study Need, Importance, and Hypothesis
Urologic reconstruction surgeries requiring a stent and/or catheter can be associated with significant CRBD, bladder-spasm associated pain and morbidity. With the growing recognition of the need to decrease opioid medication, our primary objective is to assess whether the administration of preoperative oxybutynin reduces opioid use. We hypothesize that preoperative oxybutynin reduces early postoperative opioid use in children undergoing pyeloplasty or hypospadias repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be stratified by surgery type (pyeloplasty versus hypospadias repair). The sealed envelope software will be used to assign patients to the treatment (preoperative oxybutynin) or control (placebo) group in a 1:1 ratio for both surgeries.
| Arm | Type | Receives |
|---|---|---|
| Preoperative Oxybutynin | Experimental | Drug: OxybutyninParticipants will receive oxybutynin 0.2 mg/kg (to a maximum dose of 5 mg), orally administered by the day surgery nurse in the day surgery holding area prior to surgery. |
| Preoperative Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a matching placebo tablet, orally administered by the day surgery nurse in the day surgery holding area prior to surgery. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children aged 0 to 17 years old admitted for pyeloplasty or hypospadias repair. There is no minimum weight for inclusion
Key exclusion criteria (4 listed)
- Contraindications to anticholinergic medications
- Urinary retention disorders
- Gastrointestinal obstruction/ileus
- Contraindications to anesthetic protocol, including 1) allergy to any anesthetic medication in protocol, 2) refusal of regional technique, 3) contraindications to ketorolac (i.e., recent GI bleed, recent intracranial bleed, renal dysfunction, acute kidney injury)
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 |
|---|---|---|
| OxybutyninParticipants will receive oxybutynin 0.2 mg/kg (to a maximum dose of 5 mg), orally administered by the day surgery nurse in the day surgery holding area prior to surgery. | Drug | Preoperative Oxybutynin |
| PlaceboParticipants will receive a matching placebo tablet, orally administered by the day surgery nurse in the day surgery holding area prior to surgery. | Drug | Preoperative Placebo |
Primary outcome
Total Cumulative Postoperative Opioid Consumption (MME/kg)
Time frame: From the end of surgery through 6 hours postoperatively
Total cumulative morphine milligram equivalents per kilogram (MME/kg) administered within 6 hours after surgery
5 secondary outcomes
Proportion of Participants Receiving Postoperative Opioids
Time frame: From the end of surgery through 6 hours postoperatively
Postoperative Pain Scores (NRS/FLACC)
Time frame: At 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 6 hours following postoperative removal of the laryngeal mask airway or endotracheal tube
Proportion of Participants Receiving Postoperative Rescue Oxybutynin
Time frame: From the end of surgery through 6 hours postoperatively
Total Cumulative Postoperative Oxybutynin Consumption (mg/kg)
Time frame: From the end of surgery through 6 hours postoperatively
Incidence of Adverse Events
Time frame: From preoperative study medication administration through postoperative discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Dwyer J, Tafuri SM, LaGrange CA. Oxybutynin. \[Updated 2023 Aug 17\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.Link provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxybutynin in people with Ureteropelvic Junction Obstruction and Hypospadias, run by University of Calgary at 1 site in Canada.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Nov 2026. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayder Al-Kazzaz (5878976552, hayder.alkazzaz@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cumulative Postoperative Opioid Consumption (MME/kg) (time frame: From the end of surgery through 6 hours postoperatively). 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 2 Nov 2026.