Localized Prostate CancerNCT06966778
Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial
A study testing Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. in people with Localized Prostate Cancer and Postoperative Urinary Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer, Postoperative Urinary Incontinence
- What is being tested?
- Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Patients with localized prostate cancer who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
- Age: Participants must be 18 years or older, with no upper age limit.
- Consent: Participants must provide written informed consent before undergoing any study procedures.
- Ability to Follow Protocol: Participants must be able to follow the protocol procedures throughout the study.
Who cannot join
- Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.
- Other Urinary Conditions: Participants with other diseases causing lower urinary tract symptoms (LUTS) or bladder pain, including:
- - Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection.
- - Overactive bladder or any other condition affecting bladder function.
- Chronic Medication: Participants with long-term use of medications such as:
- - Alpha-blockers, antimuscarinics, or anticholinergics.
Show all 10Show fewer
- Glaucoma: Participants with narrow-angle glaucoma.
- Urinary Retention: Participants with a history of urinary retention.
- Gastrointestinal Motility Issues: Participants with severe conditions affecting gastrointestinal motility.
- Concurrent Medications: Participants who are taking medications that are prohibited by the study protocol (e.g., cholinergic drugs, azole antifungals, smooth muscle relaxants).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy
The goal of this double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
The main questions it aims to answer are:
Read more
[Does oxybutynin chloride improve continence recovery after RARP compared to a placebo?] [What are the predictors of continence recovery?]
Researchers will compare the treatment group (oxybutynin chloride 10 mg/day) with the control group (placebo) to assess differences in continence outcomes.
Participants will:
[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.] [Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.] [Record any adverse events or concomitant medication use.]
Safety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.
Read the detailed description
Extended Description of the Protocol This study is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of oxybutynin chloride extended-release tablets (Oxbu) in improving early continence recovery following robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
Study Design and Structure
The study involves 135 patients, with 120 expected to complete all study procedures. Participants will be randomly assigned to one of two groups:
Treatment group: Receives 10 mg/day of oxybutynin chloride extended-release tablets.
Control group: Receives a placebo (identical in appearance to active drug). The treatment period lasts from 1 to 3 months, or until participants achieve complete continence, defined as no need for urinary pads and less than one episode of incontinence per week.
Intervention and Administration Dosage: Two tablets (5 mg each) taken orally once daily for both treatment and control groups.
Concomitant medications:
Prohibited: α-receptor blockers, cholinergics, and anticholinergics, among others.
Permitted: Acetaminophen and antacids, provided they are documented and do not interfere with the study objectives.
Data Collection and Efficacy Evaluation
Participants' continence outcomes will be assessed through standardized tools, including:
International Prostate Symptom Score (IPSS) International Index of Erectile Function (IIEF) International Consultation on Incontinence Questionnaire (ICIQ) Measurements will occur at baseline (pre-surgery), 10 days post-Foley catheter removal, and at intervals up to 12 months post-surgery.
Safety Monitoring All adverse events (AEs) will be recorded, with severity and relationship to the study medication assessed. AEs will be documented in Case Report Forms (CRFs) and reviewed for safety monitoring.
Statistical Analysis
Statistical analysis will involve:
Continuous variables: Assessed using independent t-tests or Mann-Whitney U tests.
Categorical variables: Compared via chi-squared, Fisher's exact tests, or linear-by-linear association tests.
Predictor analysis: Logistic regression (univariate and multivariate). Significance: p-values < 0.05. Ethical Considerations The study complies with the Declaration of Helsinki, Good Clinical Practice (GCP), and local regulations. Ethical committee approval is required before enrolling participants, and all patients must provide written informed consent prior to participation.
Timeline Enrollment period: 12 months. Treatment duration: 1-3 months. Study completion: Approximately 42 months. This extended protocol description highlights key technical aspects, intervention methods, and analytical strategies while avoiding duplication of eligibility and outcome measures previously outlined.
- Being tested
- Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd., Placebo (2 tab), PO, qd.
- Keywords
- Localized Prostate Cancer, Robot-Assisted Radical Prostatectomy (RARP), Early Continence Recovery, Postoperative Urinary Incontinence, Oxybutynin Chloride, Extended-Release Tablets, Double-Blind Randomized Study, Placebo-Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.Drug
Also called Oxybutynin Extended-Release Tablets, Oxbu, oxybutynin chloride extended-release tablet
The intervention being studied is oxybutynin chloride extended-release tablets (Oxbu), a muscarinic antagonist that is used to manage overactive bladder symptoms, including urinary incontinence. In this study, it is specifically evaluated for its potential to improve early continence recovery following robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
This formulation is an extended-release version of oxybutynin, which allows for a slower, sustained release of the drug over time, ensuring more consistent therapeutic effects with reduced side effects compared to immediate-release formulations. The intervention involves a daily dose of 10 mg, administered as two 5 mg tablets, to assess its impact on postoperative continence recovery.
The key distinction of this intervention is its focus on improving continence recovery after prostate cancer surgery, specifically through its targeted use in early post-surgical recovery, making it different from othe
Placebo (2 tab), PO, qd.Drug
placebo, which is designed to look identical to the active drug but contains no therapeutic ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. | Experimental | Description: Participants in this arm will receive oxybutynin chloride extended-release tablets (10 mg/day) to assess its effectiveness in improving early continence recovery after robot-assisted radical prostatectomy (RARP) for localized prostate cancer.
Intervention: Drug: Oxybutynin chloride extended-release tablets (10 mg/day). Receives: Drug: Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. |
| Control | Placebo comparator | Description: Participants in this arm will receive placebo tablets, identical in appearance to the active drug, to compare the effects of oxybutynin chloride with no active intervention.
Intervention: Placebo: Placebo tablets (identical in appearance to the active drug). Receives: Drug: Placebo (2 tab), PO, qd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP
Measured: Up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Model description
- In this parallel assignment interventional study model, participants are randomly assigned to one of two groups, with each group receiving a different intervention: Treatment Group: Participants will receive oxybutynin chloride extended-release tablets (10 mg/day) to assess the impact of the drug on early continence recovery following robot-assisted radical prostatectomy (RARP) for localized prostate cancer. Control Group: Participants will receive a placebo (identical in appearance to the active drug) to compare the effects of oxybutynin chloride with no active intervention. Both groups will undergo the same follow-up protocol, with assessments of continence recovery, adverse events, and other outcomes conducted at multiple time points (e.g., pre-surgery, 10 days post-Foley catheter removal, and at 1, 3, 6, 9, and 12 months post-surgery). This study design allows for a direct comparison between the treatment and control groups, helping to determine the effective
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Synmosa Biopharma Corp.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966778
- Sponsor's protocol ID
- 202412012MIPD
- Status last verified
- Sep 2025
- First submitted
- 4 May 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lim KT, Kim YT, Lee TY, Park SY. Effects of tamsulosin, solifenacin, and combination therapy for the treatment of ureteral stent related discomforts. Korean J Urol. 2011 Jul;52(7):485-8. doi: 10.4111/kju.2011.52.7.485. Epub 2011 Jul 24.
PubMed 21860770Ho CH, Chang TC, Lin HH, Liu SP, Huang KH, Yu HJ. Solifenacin and tolterodine are equally effective in the treatment of overactive bladder symptoms. J Formos Med Assoc. 2010 Oct;109(10):702-8. doi: 10.1016/S0929-6646(10)60114-3.
PubMed 20970066Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
PubMed 19930331Yakoubi R, Lemdani M, Monga M, Villers A, Koenig P. Is there a role for alpha-blockers in ureteral stent related symptoms? A systematic review and meta-analysis. J Urol. 2011 Sep;186(3):928-34. doi: 10.1016/j.juro.2011.04.061. Epub 2011 Jul 24.
PubMed 21791359Beddingfield R, Pedro RN, Hinck B, Kreidberg C, Feia K, Monga M. Alfuzosin to relieve ureteral stent discomfort: a prospective, randomized, placebo controlled study. J Urol. 2009 Jan;181(1):170-6. doi: 10.1016/j.juro.2008.09.026. Epub 2008 Nov 14.
PubMed 19013590Damiano R, Autorino R, De Sio M, Giacobbe A, Palumbo IM, D'Armiento M. Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study. J Endourol. 2008 Apr;22(4):651-6. doi: 10.1089/end.2007.0257.
PubMed 18338955Park SC, Jung SW, Lee JW, Rim JS. The effects of tolterodine extended release and alfuzosin for the treatment of double-j stent-related symptoms. J Endourol. 2009 Nov;23(11):1913-7. doi: 10.1089/end.2009.0173.
PubMed 19814699Walz J, Epstein JI, Ganzer R, Graefen M, Guazzoni G, Kaouk J, Menon M, Mottrie A, Myers RP, Patel V, Tewari A, Villers A, Artibani W. A Critical Analysis of the Current Knowledge of Surgical Anatomy of the Prostate Related to Optimisation of Cancer Control and Preservation of Continence and Erection in Candidates for Radical Prostatectomy: An Update. Eur Urol. 2016 Aug;70(2):301-11. doi: 10.1016/j.eururo.2016.01.026. Epub 2016 Feb 2.
PubMed 26850969Heesakkers J, Farag F, Bauer RM, Sandhu J, De Ridder D, Stenzl A. Pathophysiology and Contributing Factors in Postprostatectomy Incontinence: A Review. Eur Urol. 2017 Jun;71(6):936-944. doi: 10.1016/j.eururo.2016.09.031. Epub 2016 Oct 6.
PubMed 27720536Salomon L. Re: Bianco FJ, Scardino PT, and Eastham JA: Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("Trifecta") (Urology 66(5 suppl): 83-94, 2005). Urology. 2008 Feb;71(2):362. doi: 10.1016/j.urology.2005.12.053. No abstract available.
PubMed 18308133Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. doi: 10.1016/j.eururo.2012.05.045. Epub 2012 Jun 1.
PubMed 22749852Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, Albertsen PC, Harlan LC, Potosky AL. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA. 2000 Jan 19;283(3):354-60. doi: 10.1001/jama.283.3.354.
PubMed 10647798Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.
PubMed 27626365Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.
PubMed 27626136
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy
- ClinicalTrials.gov ID
- NCT06966778
- Acronym / sponsor ID
- 202412012MIPD
- Keywords
- Localized Prostate Cancer, Robot-Assisted Radical Prostatectomy (RARP), Early Continence Recovery, Postoperative Urinary Incontinence, Oxybutynin Chloride, Extended-Release Tablets, Double-Blind Randomized Study, Placebo-Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Synmosa Biopharma Corp.
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 May 2025 (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 double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
The main questions it aims to answer are:
[Does oxybutynin chloride improve continence recovery after RARP compared to a placebo?] [What are the predictors of continence recovery?]
Researchers will compare the treatment group (oxybutynin chloride 10 mg/day) with the control group (placebo) to assess differences in continence outcomes.
Participants will:
[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.] [Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.] [Record any adverse events or concomitant medication use.]
Safety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.
Detailed description
Extended Description of the Protocol This study is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of oxybutynin chloride extended-release tablets (Oxbu) in improving early continence recovery following robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
Study Design and Structure
The study involves 135 patients, with 120 expected to complete all study procedures. Participants will be randomly assigned to one of two groups:
Treatment group: Receives 10 mg/day of oxybutynin chloride extended-release tablets.
Control group: Receives a placebo (identical in appearance to active drug). The treatment period lasts from 1 to 3 months, or until participants achieve complete continence, defined as no need for urinary pads and less than one episode of incontinence per week.
Intervention and Administration Dosage: Two tablets (5 mg each) taken orally once daily for both treatment and control groups.
Concomitant medications:
Prohibited: α-receptor blockers, cholinergics, and anticholinergics, among others.
Permitted: Acetaminophen and antacids, provided they are documented and do not interfere with the study objectives.
Data Collection and Efficacy Evaluation
Participants' continence outcomes will be assessed through standardized tools, including:
International Prostate Symptom Score (IPSS) International Index of Erectile Function (IIEF) International Consultation on Incontinence Questionnaire (ICIQ) Measurements will occur at baseline (pre-surgery), 10 days post-Foley catheter removal, and at intervals up to 12 months post-surgery.
Safety Monitoring All adverse events (AEs) will be recorded, with severity and relationship to the study medication assessed. AEs will be documented in Case Report Forms (CRFs) and reviewed for safety monitoring.
Statistical Analysis
Statistical analysis will involve:
Continuous variables: Assessed using independent t-tests or Mann-Whitney U tests.
Categorical variables: Compared via chi-squared, Fisher's exact tests, or linear-by-linear association tests.
Predictor analysis: Logistic regression (univariate and multivariate). Significance: p-values < 0.05. Ethical Considerations The study complies with the Declaration of Helsinki, Good Clinical Practice (GCP), and local regulations. Ethical committee approval is required before enrolling participants, and all patients must provide written informed consent prior to participation.
Timeline Enrollment period: 12 months. Treatment duration: 1-3 months. Study completion: Approximately 42 months. This extended protocol description highlights key technical aspects, intervention methods, and analytical strategies while avoiding duplication of eligibility and outcome measures previously outlined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In this parallel assignment interventional study model, participants are randomly assigned to one of two groups, with each group receiving a different intervention: Treatment Group: Participants will receive oxybutynin chloride extended-release tablets (10 mg/day) to assess the impact of the drug on early continence recovery following robot-assisted radical prostatectomy (RARP) for localized prostate cancer. Control Group: Participants will receive a placebo (identical in appearance to the active drug) to compare the effects of oxybutynin chloride with no active intervention. Both groups will undergo the same follow-up protocol, with assessments of continence recovery, adverse events, and other outcomes conducted at multiple time points (e.g., pre-surgery, 10 days post-Foley catheter removal, and at 1, 3, 6, 9, and 12 months post-surgery). This study design allows for a direct comparison between the treatment and control groups, helping to determine the effective
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. | Experimental | Drug: Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.Description: Participants in this arm will receive oxybutynin chloride extended-release tablets (10 mg/day) to assess its effectiveness in improving early continence recovery after robot-assisted radical prostatectomy (RARP) for localized prostate cancer. Intervention: Drug: Oxybutynin chloride extended-release tablets (10 mg/day). |
| Control | Placebo comparator | Drug: Placebo (2 tab), PO, qd.Description: Participants in this arm will receive placebo tablets, identical in appearance to the active drug, to compare the effects of oxybutynin chloride with no active intervention. Intervention: Placebo: Placebo tablets (identical in appearance to the active drug). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis: Patients with localized prostate cancer who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
- Age: Participants must be 18 years or older, with no upper age limit.
- Consent: Participants must provide written informed consent before undergoing any study procedures.
- Ability to Follow Protocol: Participants must be able to follow the protocol procedures throughout the study.
Key exclusion criteria (10 listed)
- Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.
- Other Urinary Conditions: Participants with other diseases causing lower urinary tract symptoms (LUTS) or bladder pain, including:
- - Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection.
- - Overactive bladder or any other condition affecting bladder function.
- Chronic Medication: Participants with long-term use of medications such as:
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 chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.Also: Oxybutynin Extended-Release Tablets, Oxbu, oxybutynin chloride extended-release tabletThe intervention being studied is oxybutynin chloride extended-release tablets (Oxbu), a muscarinic antagonist that is used to manage overactive bladder symptoms, including urinary incontinence. In this study, it is specifically evaluated for its potential to improve early continence recovery following robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer. This formulation is an extended-release version of oxybutynin, which allows for a slower, sustained release of the drug over time, ensuring more consistent therapeutic effects with reduced side effects compared to immediate-release formulations. The intervention involves a daily dose of 10 mg, administered as two 5 mg tablets, to assess its impact on postoperative continence recovery. The key distinction of this intervention is its focus on improving continence recovery after prostate cancer surgery, specifically through its targeted use in early post-surgical recovery, making it different from othe | Drug | Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. |
| Placebo (2 tab), PO, qd.placebo, which is designed to look identical to the active drug but contains no therapeutic ingredient. | Drug | Control |
Primary outcome
Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP
Time frame: Up to 12 months post-surgery
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 16 Mar 2026.
- Results publication: PubMed 21860770Lim KT, Kim YT, Lee TY, Park SY. Effects of tamsulosin, solifenacin, and combination therapy for the treatment of ureteral stent related discomforts. Korean J Urol. 2011 Jul;52(7):485-8. doi: 10.4111/kju.2011.52.7.485. Epub 2011 Jul 24.
- Results publication: PubMed 20970066Ho CH, Chang TC, Lin HH, Liu SP, Huang KH, Yu HJ. Solifenacin and tolterodine are equally effective in the treatment of overactive bladder symptoms. J Formos Med Assoc. 2010 Oct;109(10):702-8. doi: 10.1016/S0929-6646(10)60114-3.
- Results publication: PubMed 19930331Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
- Results publication: PubMed 21791359Yakoubi R, Lemdani M, Monga M, Villers A, Koenig P. Is there a role for alpha-blockers in ureteral stent related symptoms? A systematic review and meta-analysis. J Urol. 2011 Sep;186(3):928-34. doi: 10.1016/j.juro.2011.04.061. Epub 2011 Jul 24.
- Results publication: PubMed 19013590Beddingfield R, Pedro RN, Hinck B, Kreidberg C, Feia K, Monga M. Alfuzosin to relieve ureteral stent discomfort: a prospective, randomized, placebo controlled study. J Urol. 2009 Jan;181(1):170-6. doi: 10.1016/j.juro.2008.09.026. Epub 2008 Nov 14.
- Results publication: PubMed 18338955Damiano R, Autorino R, De Sio M, Giacobbe A, Palumbo IM, D'Armiento M. Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study. J Endourol. 2008 Apr;22(4):651-6. doi: 10.1089/end.2007.0257.
- Results publication: PubMed 19814699Park SC, Jung SW, Lee JW, Rim JS. The effects of tolterodine extended release and alfuzosin for the treatment of double-j stent-related symptoms. J Endourol. 2009 Nov;23(11):1913-7. doi: 10.1089/end.2009.0173.
- Results publication: PubMed 26850969Walz J, Epstein JI, Ganzer R, Graefen M, Guazzoni G, Kaouk J, Menon M, Mottrie A, Myers RP, Patel V, Tewari A, Villers A, Artibani W. A Critical Analysis of the Current Knowledge of Surgical Anatomy of the Prostate Related to Optimisation of Cancer Control and Preservation of Continence and Erection in Candidates for Radical Prostatectomy: An Update. Eur Urol. 2016 Aug;70(2):301-11. doi: 10.1016/j.eururo.2016.01.026. Epub 2016 Feb 2.
- Results publication: PubMed 27720536Heesakkers J, Farag F, Bauer RM, Sandhu J, De Ridder D, Stenzl A. Pathophysiology and Contributing Factors in Postprostatectomy Incontinence: A Review. Eur Urol. 2017 Jun;71(6):936-944. doi: 10.1016/j.eururo.2016.09.031. Epub 2016 Oct 6.
- Results publication: PubMed 18308133Salomon L. Re: Bianco FJ, Scardino PT, and Eastham JA: Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("Trifecta") (Urology 66(5 suppl): 83-94, 2005). Urology. 2008 Feb;71(2):362. doi: 10.1016/j.urology.2005.12.053. No abstract available.
- Results publication: PubMed 22749852Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. doi: 10.1016/j.eururo.2012.05.045. Epub 2012 Jun 1.
- Results publication: PubMed 10647798Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, Albertsen PC, Harlan LC, Potosky AL. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA. 2000 Jan 19;283(3):354-60. doi: 10.1001/jama.283.3.354.
- 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 study testing Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. in people with Localized Prostate Cancer and Postoperative Urinary Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 10 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 16 Mar 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 Taiwan. 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.
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 Kuo-How Huang Kuo-How Huang, Professor (+886-2-2312-3456 ext. 265952, khhuang123@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP (time frame: Up to 12 months post-surgery). 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 NCT06966778, which also lists 14 linked publications.
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 16 Mar 2026.