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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Oxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd.
  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
• Препарат Placebo (2 tab), PO, qd.
  placebo, which is designed to look identical to the active drug but contains no therapeutic ingredient.

Первичные конечные точки

• Number of Participants Achieving Urinary Continence (0-1 Pad/Day) Within 12 Months After RARP [Срок оценки: Up to 12 months post-surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Публикации

• 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. PMID 21860770
• 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
• 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
• 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
• 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
• 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
• 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
• 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 PMID 26850969

Идентификаторы

NCT: NCT06966778 · 202412012MIPD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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