Male Urogenital DiseasesPhase 2PRETIPUVNCT04526353
Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
A Phase 2 study testing Oxybutynin 1 mg/ml Syrup in people with Male Urogenital Diseases, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been any clear studies on the subject. Read more about this study
- Who is it for?
- Ages 3 to 6 months, men only
- Conditions the study is for
- Male Urogenital Diseases
- What is being tested?
- Oxybutynin 1 mg/ml Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2020to 10 Sep 2028
- Phase
- Phase 2
- 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 3 to 6 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Boys
- Aged 3 to 6 months
- Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life
- Children who have had their valve resection at least 3 months before inclusion
- Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (>60cm H2O)/ small capacity bladder (<70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (<10ml/cmH2O)/
- Holders of parental authority affiliated to French national health insurance
- With informed consent signed by holders of parental authority
Who cannot join
- Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment
- Boys in whom urodynamic assessment is not possible for medical or anatomical reasons
- Boys requiring dialysis before the age of 3 months
- Contra-indication to oxybutynin such as hypersensitivity to oxybutynin or any of the excipients, digestive obstruction, occlusive or sub-occlusive syndrome, megacolon, digestive stasis, intestinal atony, paralytic ileus, ulcerative colitis, Hemorrhagic rectocolitis, Crohn's disease, Inflammatory bowel disease, Inflammatory organic colopathy, myasthenia, congenital glaucoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Luke L HARPER, MD, +33 05 56 79 56 17, luke.harper@chu-bordeaux.fr
About this study
Official title: Prospective Randomized Clinical Trial of Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been any clear studies on the subject. To our knowledge, no comparative study of the evolution of valve bladders with or without treatment has been carried out to date.
Anticholinergic treatment, although it may be beneficial in patients with abnormal bladder function, such as the neurologic bladders ( in Spina Bifida) for example, may have side effects and may not be of benefit for this valve population. The evolution of the valves could be spontaneously favorable.
This study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.
Read the detailed description
Posterior urethral valves (VUPs) are the leading cause of subvesical obstruction in children with an incidence between 1 / 3,000 to 1 / 8,000 births. 25-45% of patients will have chronic renal failure and 10-20% will require a transplant. The association between long-term prognosis and bladder dysfunction is well known, leading many teams to suggest early initiation of treatment with anticholinergics.
However, this treatment has never been properly evaluated. In fact, a single study carried out in boys with valves taking oxybutynin from the age of 3 months to 2 years without a control group concluded that "the early use of anticholinergics in boys with VUP presenting high voiding pressures and low bladder capacity has a beneficial effect on bladder function. It is true that in children with neurologic bladders as in Spina Bifida, early treatment with anticholinergics seems to provide a benefit, but VUPs are not strictly speaking neurologic bladders. In addition, treatment with anticholinergics can have side effects and could even be harmful to the bladder, leading to myogenic bankruptcy. The only way to properly assess oxybutynin in this population is to conduct a prospective randomized study.
The proposed study includes a group treated with oxybutynin and a group without. Boys who have had valve resection for VUP within the first three months of life and who present an abnormal urodynamic assessment 3 months after valve resection will be included. Oxybutynin will be given at a dose of 0.1 mg / kg 2x / day, as syrup, in the treatment group. The control group will not have any treatment affecting bladder function. The pharmacokinetics of oxybutynin will be studied. Several urodynamic parameters including capacity or volume, voiding pressure and compliance will be studied. The objective is to perform a composite analysis that can reflect the complex functioning of the bladder. The children included will have urodynamics at the end of the study, after 9 months of treatment. The performance of urodynamic examinations will be standardized and there will be an external centralized analysis to validate the urodynamic results.
- Conditions
- Male Urogenital Diseases
- Being tested
- Oxybutynin 1 mg/ml Syrup
- Keywords
- posterior urethral valves, urodynamic, anticholinergic
- Medical subject headings
- Male Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin 1 mg/ml SyrupDrug
The Investigational Medicinal Product of this study is Oxybutynin 1 mg/ml Syrup (see Annex 1 for the Monograph of PMS-Oxybutynin provided by ANSM under the ATU.). It will be administered at the dose of 0.1 mg/kg/twice a day to patients randomized to the study treatment group. The dose will be adapted to the child's weight to the nearest kilogram.
The recommended dosage for older children with neurologic bladder is 0.3 to 0.4mg/kg/day, whilst the dosage we will be using is effectively 0.2mg/kg/day. This is because we are taking into account the absence or pharmacological studies of oxybutynin use in children <1 year of age, as well as their specific liver metabolism. Furthermore, the dose of 0.1mg/kg twice daily is the dose used in children within the same age group in the study by Casey et al, 2012
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin during 9 months. | Experimental | 0.1mg / kg 2x / day from inclusion and for 9 months. Receives: Drug: Oxybutynin 1 mg/ml Syrup |
| No oxybutynin | No intervention | No treatment affecting bladder function |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of treatment defined by the association of the three events
composite endpoints where the success of treatment at 9 months after inclusion is defined by the association of the three following events:
- Voiding pressure <60 cmH2O AND
- Bladder Volume ≥70% of theoretical value AND
- for those without pop-off mechanisms, Bladder compliance >10mL/cmH2O A failure of treatment will be defined as the absence of at least one of these events.
In presence of a pressure pop-off mechanism, only voiding pressure and bladder volume will be analyzed.
Measured: 9 months after inclusion
Secondary outcomes (14)
Proportion of adverse events in each group
Measured: through study completion, an average of 9 months
Type of adverse events in each group
adverse event or serious adverse event
Measured: through study completion, an average of 9 months
Incidence of urinary tract infections in each group
Measured: through study completion, an average of 9 months
Compliance with treatment
Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption
Measured: 9 months after inclusion
Sonographic changes
Sonographic changes will be expressed as a degree of hydronephrosis at 12-15 months of life (9 months after inclusion)
Measured: 9 months after inclusion
Area under the plasma concentration versus time curve (AUC) of oxybutynin in treated boys over treatment
Area under the plasma concentration versus time curve (AUC) of oxybutinin in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Peak Plasma Concentration (Cmax) of oxybutynin in treated boys over treatment
Peak Plasma Concentration (Cmax) of oxybutynin in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Minimum plasma concentration (Cmin) of oxybutynin in treated boys over treatment
Minimum plasma concentration (Cmin) of oxybutynin in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Half-life of oxybutynin in treated boys over treatment
Half-life of oxybutynin in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Area under the plasma concentration versus time curve (AUC) of desethyloxybutynin (metabolite) in treated boys over treatment
Area under the plasma concentration versus time curve (AUC) of desethyloxybutynin (active metabolite) in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Peak Plasma Concentration (Cmax) of desethyloxybutynin (metabolite) in treated boys over treatment
Peak Plasma Concentration (Cmax) of desethyloxybutynin (active metabolite) in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Minimum plasma concentration (Cmin) of desethyloxybutynin (metabolite) in treated boys over treatment
Minimum plasma concentration (Cmin) of desethyloxybutynin (active metabolite) in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
Half-life of desethyloxybutynin (metabolite) in treated boys over treatment
Half-life of desethyloxybutynin (active metabolite) in treated boys over treatment. Pharmacokinetic samples (6 points from Cmin to H+3h) at 2 weeks, 3 and 9 months after inclusion will be used to study and determine the pharmacokinetic parameters. In order to avoid having to take blood sample from the child several times, it is proposed to use a small venous catheter during the time of the pharmacokinetic samples
Measured: through study completion, an average of 9 months
creatinine clearance in each group
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start10 Sep 2020
- Primary completionFeb 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male Urogenital DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2 non comparative randomized multicentre clinical trial with two parallel groups: * Oxybutynin (0.1 mg/kg twice daily) during 9 months. * No oxybutynin To determine whether the observed effects of oxybutynin are really due to the treatment we need to perform a randomized clinical trial. There is insufficient evidence in the literature about the natural evolution of the bladder in boys with PUV. Given the paucity of literature data, our objective is not to formally test the superiority of oxybutynin versus no drug but to detect and quantify the effect of oxybutynin. This is why our clinical is randomized but non-comparative.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent L FOURCADE, MD, Principal investigator, University Hospital, LimogesAlice A FAURE, MD, Principal investigator, APHM - Hôpital Timone EnfantsThomas BLANC, MD, Principal investigator, APHP - Hôpital Necker Enfants MaladesAlaa A EL GHONEIMI, MD, Principal investigator, APHP- Hôpital Robert DebréAlexis A ARNAUD, MD, Principal investigator, Rennes University HospitalOurdia O BOUALI, MD, Principal investigator, University Hospital, ToulouseJean-Baptiste JB MARRET, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526353
- Sponsor's protocol ID
- CHUBX 2018/65
- Other IDs
- 2024-515844-22-00
- Acronym
- PRETIPUV
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casey JT, Hagerty JA, Maizels M, Chaviano AH, Yerkes E, Lindgren BW, Kaplan WE, Meyer T, Cheng EY. Early administration of oxybutynin improves bladder function and clinical outcomes in newborns with posterior urethral valves. J Urol. 2012 Oct;188(4 Suppl):1516-20. doi: 10.1016/j.juro.2012.03.068. Epub 2012 Aug 19.
PubMed 22910256
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial of Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
- ClinicalTrials.gov ID
- NCT04526353
- Acronym / sponsor ID
- PRETIPUV / CHUBX 2018/65
- Conditions
- Male Urogenital Diseases
- Keywords
- posterior urethral valves, urodynamic, anticholinergic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 25 Aug 2020 (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.
Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been any clear studies on the subject. To our knowledge, no comparative study of the evolution of valve bladders with or without treatment has been carried out to date.
Anticholinergic treatment, although it may be beneficial in patients with abnormal bladder function, such as the neurologic bladders ( in Spina Bifida) for example, may have side effects and may not be of benefit for this valve population. The evolution of the valves could be spontaneously favorable.
This study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.
Detailed description
Posterior urethral valves (VUPs) are the leading cause of subvesical obstruction in children with an incidence between 1 / 3,000 to 1 / 8,000 births. 25-45% of patients will have chronic renal failure and 10-20% will require a transplant. The association between long-term prognosis and bladder dysfunction is well known, leading many teams to suggest early initiation of treatment with anticholinergics.
However, this treatment has never been properly evaluated. In fact, a single study carried out in boys with valves taking oxybutynin from the age of 3 months to 2 years without a control group concluded that "the early use of anticholinergics in boys with VUP presenting high voiding pressures and low bladder capacity has a beneficial effect on bladder function. It is true that in children with neurologic bladders as in Spina Bifida, early treatment with anticholinergics seems to provide a benefit, but VUPs are not strictly speaking neurologic bladders. In addition, treatment with anticholinergics can have side effects and could even be harmful to the bladder, leading to myogenic bankruptcy. The only way to properly assess oxybutynin in this population is to conduct a prospective randomized study.
The proposed study includes a group treated with oxybutynin and a group without. Boys who have had valve resection for VUP within the first three months of life and who present an abnormal urodynamic assessment 3 months after valve resection will be included. Oxybutynin will be given at a dose of 0.1 mg / kg 2x / day, as syrup, in the treatment group. The control group will not have any treatment affecting bladder function. The pharmacokinetics of oxybutynin will be studied. Several urodynamic parameters including capacity or volume, voiding pressure and compliance will be studied. The objective is to perform a composite analysis that can reflect the complex functioning of the bladder. The children included will have urodynamics at the end of the study, after 9 months of treatment. The performance of urodynamic examinations will be standardized and there will be an external centralized analysis to validate the urodynamic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 2 non comparative randomized multicentre clinical trial with two parallel groups: * Oxybutynin (0.1 mg/kg twice daily) during 9 months. * No oxybutynin To determine whether the observed effects of oxybutynin are really due to the treatment we need to perform a randomized clinical trial. There is insufficient evidence in the literature about the natural evolution of the bladder in boys with PUV. Given the paucity of literature data, our objective is not to formally test the superiority of oxybutynin versus no drug but to detect and quantify the effect of oxybutynin. This is why our clinical is randomized but non-comparative.
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin during 9 months. | Experimental | Drug: Oxybutynin 1 mg/ml Syrup0.1mg / kg 2x / day from inclusion and for 9 months. |
| No oxybutynin | No intervention | –No treatment affecting bladder function |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Boys
- Aged 3 to 6 months
- Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life
- Children who have had their valve resection at least 3 months before inclusion
- Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (>60cm H2O)/ small capacity bladder (<70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (<10ml/cmH2O)/
Key exclusion criteria (4 listed)
- Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment
- Boys in whom urodynamic assessment is not possible for medical or anatomical reasons
- Boys requiring dialysis before the age of 3 months
- Contra-indication to oxybutynin such as hypersensitivity to oxybutynin or any of the excipients, digestive obstruction, occlusive or sub-occlusive syndrome, megacolon, digestive stasis, intestinal atony, paralytic ileus, ulcerative colitis, Hemorrhagic rectocolitis, Crohn's disease, Inflammatory bowel disease, Inflammatory organic colopathy, myasthenia, congenital glaucoma
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 |
|---|---|---|
| Oxybutynin 1 mg/ml SyrupThe Investigational Medicinal Product of this study is Oxybutynin 1 mg/ml Syrup (see Annex 1 for the Monograph of PMS-Oxybutynin provided by ANSM under the ATU.). It will be administered at the dose of 0.1 mg/kg/twice a day to patients randomized to the study treatment group. The dose will be adapted to the child's weight to the nearest kilogram. The recommended dosage for older children with neurologic bladder is 0.3 to 0.4mg/kg/day, whilst the dosage we will be using is effectively 0.2mg/kg/day. This is because we are taking into account the absence or pharmacological studies of oxybutynin use in children <1 year of age, as well as their specific liver metabolism. Furthermore, the dose of 0.1mg/kg twice daily is the dose used in children within the same age group in the study by Casey et al, 2012 | Drug | Oxybutynin during 9 months. |
Primary outcome
success of treatment defined by the association of the three events
Time frame: 9 months after inclusion
composite endpoints where the success of treatment at 9 months after inclusion is defined by the association of the three following events: * Voiding pressure <60 cmH2O AND * Bladder Volume ≥70% of theoretical value AND * for those without pop-off mechanisms, Bladder compliance >10mL/cmH2O A failure of treatment will be defined as the absence of at least one of these events. In presence of a pressure pop-off mechanism, only voiding pressure and bladder volume will be analyzed.
14 secondary outcomes
Proportion of adverse events in each group
Time frame: through study completion, an average of 9 months
Type of adverse events in each group
Time frame: through study completion, an average of 9 months
Incidence of urinary tract infections in each group
Time frame: through study completion, an average of 9 months
Compliance with treatment
Time frame: 9 months after inclusion
Sonographic changes
Time frame: 9 months after inclusion
Area under the plasma concentration versus time curve (AUC) of oxybutynin in treated boys over treatment
Time frame: through study completion, an average of 9 months
Peak Plasma Concentration (Cmax) of oxybutynin in treated boys over treatment
Time frame: through study completion, an average of 9 months
Minimum plasma concentration (Cmin) of oxybutynin in treated boys over treatment
Time frame: through study completion, an average of 9 months
Half-life of oxybutynin in treated boys over treatment
Time frame: through study completion, an average of 9 months
Area under the plasma concentration versus time curve (AUC) of desethyloxybutynin (metabolite) in treated boys over treatment
Time frame: through study completion, an average of 9 months
Peak Plasma Concentration (Cmax) of desethyloxybutynin (metabolite) in treated boys over treatment
Time frame: through study completion, an average of 9 months
Minimum plasma concentration (Cmin) of desethyloxybutynin (metabolite) in treated boys over treatment
Time frame: through study completion, an average of 9 months
Half-life of desethyloxybutynin (metabolite) in treated boys over treatment
Time frame: through study completion, an average of 9 months
creatinine clearance in each group
Time frame: through study completion, an average of 9 months
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 10 Jun 2026.
- Background: PubMed 22910256Casey JT, Hagerty JA, Maizels M, Chaviano AH, Yerkes E, Lindgren BW, Kaplan WE, Meyer T, Cheng EY. Early administration of oxybutynin improves bladder function and clinical outcomes in newborns with posterior urethral valves. J Urol. 2012 Oct;188(4 Suppl):1516-20. doi: 10.1016/j.juro.2012.03.068. Epub 2012 Aug 19.
- Individual participant dataSharing planned: No
Related trials for Male Urogenital Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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.
Laurent L FOURCADE, MD principal investigator
University Hospital, Limoges
Alice A FAURE, MD principal investigator
APHM - Hôpital Timone Enfants
Thomas BLANC, MD principal investigator
APHP - Hôpital Necker Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxybutynin 1 mg/ml Syrup in people with Male Urogenital Diseases, run by University Hospital, Bordeaux at 1 site in France.
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 7 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: looking for participants now, as of the sponsor's last update on 10 Jun 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Luke L HARPER, MD (05 56 79 56 17, luke.harper@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of treatment defined by the association of the three events (time frame: 9 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526353, which also lists 1 linked publication.
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 10 Jun 2026.