Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial

NCT06966778 | Recruiting

• 1 other identifier: 202412012MIPD
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Urinary Incontinence; Localized Prostate Cancer

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP

  Up to 12 months post-surgery

Study Arms (2)

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).

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).

Drug: Placebo (2 tab), PO, qd.

Interventions

Placebo (2 tab), PO, qd. DRUG

placebo, which is designed to look identical to the active drug but contains no therapeutic ingredient.

Control

Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd. DRUG

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

Also known as: Oxybutynin Extended-Release Tablets, Oxbu, oxybutynin chloride extended-release tablet

Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Synmosa Biopharma Corp.: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (14)

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  PMID: 21860770 RESULT

• Ho 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.

  PMID: 20970066 RESULT

• Vardy 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.

  PMID: 19930331 RESULT

• Yakoubi 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.

  PMID: 21791359 RESULT

• Beddingfield 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.

  PMID: 19013590 RESULT

• Damiano 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.

  PMID: 18338955 RESULT

• Park 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.

  PMID: 19814699 RESULT

• Walz 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.

  PMID: 26850969 RESULT

• Heesakkers 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.

  PMID: 27720536 RESULT

• Salomon 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.

  PMID: 18308133 RESULT

• Ficarra 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.

  PMID: 22749852 RESULT

• Stanford 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.

  PMID: 10647798 RESULT

• Donovan 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.

  PMID: 27626365 RESULT

• Hamdy 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.

  PMID: 27626136 RESULT

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Kuo-How Huang Kuo-How Huang, Professor

CONTACT

+886-2-2312-3456; khhuang123@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In this study, study coordinators and data analysts are also masked to ensure that there is no bias in the data collection and analysis process. This further ensures that the evaluation of outcomes, such as the effectiveness of the treatment and the assessment of adverse events, is unbiased and objective.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2025-09

Locations

TW (1)