Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate) (POST-TURP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier:
NCT01747577
First received: December 10, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to demonstrate superiority of the solifenacin succinate (treatment) over the placebo (control) based on the change from the baseline in the mean number of urgency episodes per 24 hours after 2 weeks.


Condition Intervention Phase
Overactive Bladder
Benign Prostate Hyperplasia
Transurethral Resection of Prostate
Photoselective Vaporization Prostatectomy
Drug: Solifenacin Succinate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, and Phase IV Study of Efficacy and Safety of Solifenacin Succinate in Patients With Overactive Bladder After TURP or PVP

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 2 [ Time Frame: Baseline and at week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 4 [ Time Frame: Baseline and at week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in IPSS total score [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
    IPSS: International Prostate Symptom Score

  • Changes from baseline in IPSS storage subscale score [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
  • Changes from baseline in IPSS voiding subscale score [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
  • Changes from baseline in individual IPSS scores [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
  • Changes from baseline in IPSS QOL [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
    QOL: Quality of Life

  • Changes from baseline in OABSS total score [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
    OABSS: OverActive Bladder Sympton Score

  • Change from baseline in average number of micturitions per 24 hrs for three days as recorded in the voiding diary [ Time Frame: Baseline, at week 2 and at week 4 ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, physical exam, and vital signs [ Time Frame: For 4 weeks of the treatment ] [ Designated as safety issue: No ]
  • Urinal post voiding residual volume [ Time Frame: Before treatment at week 2 and at week 4 ] [ Designated as safety issue: Yes ]
    Measured by ultrasound or bladder scan

  • Maximum flow rate of the urine [ Time Frame: Before treatment at week 2 and at week 4 ] [ Designated as safety issue: Yes ]
    Assessment using uroflowmetry


Enrollment: 68
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solifenacin group Drug: Solifenacin Succinate
Oral
Other Names:
  • YM905
  • Vesicare®
Placebo Comparator: Placebo group Drug: Placebo
Oral

Detailed Description:

The BPH (benign prostate hyperplasia) patients who have OAB (overactive bladder) after TURP (trans-urethral resection of prostate) or PVP (photoselective vaporization of prostate) will participate in this study. The subjects will be randomized 1:1 to the solifenacin succinate group or to the placebo treatment group. The subjects shall take investigational product each night before sleeping from for four weeks and complete voiding diary. At Week-2 and Week-4 of the treatment, the subjects will be asked to complete the following activities: physical exam, vital signs test, IPSS, OABSS, post-void residual (PVR) test, and uroflowmetry, and will be asked to answer the BSW, (Benefit, Satisfaction and Willingness to Continue Questions) questionnaire.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening

    • Patients who are willing and able to accurately complete the voiding diary, IPSS, and OABSS
    • Patients who have been diagnosed with BPH and are scheduled to receive TURP or PVP
  • Randomization (after TURP or PVP)

    • Patients who have been diagnosed with OAB by the investigators
    • Patients who underwent catheter removal 5±2 days beforehand and will have more than an average of three urgency episodes per 24 hrs and more than an average of eight micturitions per 24 hrs in a row before Visit 3, as recorded in the voiding diary
    • Patients who will score more than 5 in questions 2, 4, and 7, which are on the storage symptoms in IPSS
    • Patients who will score more than 4 in question 3 and more than 5 in the OABSS
    • Patients who have not been treated with any medication for overactive bladder (OAB) symptoms 14 days before the randomization

Exclusion Criteria:

  • Screening

    • Patients who have been diagnosed with prostate cancer or bladder cancer and who have a present or resolved malignant disease in any pelvic organ
    • Patients who have neurological diseases that affect micturition and can cause neurogenic bladder disease such as multiple sclerosis, Parkinson's disease, severe cerebral arteriosclerosis, dementia, stroke, or myelitis
    • Patients who have had serious adverse events or are hypersensitive to anticholinergics
    • Patients who have a severe gastrointestinal obstruction disease such as toxin megacolon, ulcerative colitis, intestinal atonia, paralytic ileus, and gastric retention
    • Patients who have been diagnosed with severe myasthenia
    • Patients who have been diagnosed with narrow-angle glaucoma
    • Patients who have serious hepatic impairment (child class C)
    • Patients who are being treated with a CYP3A4 inhibitor (e.g., Ketoconazole)
    • Patients who have severe renal impairment or who are undergoing hemodialysis
    • Patients who have diabetic neuropathy
    • Patients who have a significant urinogenital disease such as UTI, interstitial cystitis, urothelial tumor, bladder stone, or urinary retention
    • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
    • Patients who have another medical or psychiatric condition that will make them inappropriate for participate in this study in the opinion of the investigators
    • Patients who have participated in other clinical trials within 30 days before the screening visit
  • Randomization

    • Patients who have been diagnosed with clinically significant bladder outlet obstruction by investigators
    • Patients whose PVR is greater than 100 mL
    • Patients who have been diagnosed with prostate cancer or bladder cancer and who have a present or resolved malignant disease in any pelvic organ
    • Patients who have neurological diseases that affect micturition and can cause neurogenic bladder disease such as multiple sclerosis, Parkinson's disease, severe cerebral arteriosclerosis, dementia, stroke, or myelitis
    • Patients who have had serious adverse events or are hypersensitive to anticholinergics
    • Patients who have a severe gastrointestinal obstruction disease such as toxin megacolon, ulcerative colitis, intestinal atonia, paralytic ileus, and gastric retention
    • Patients who have been diagnosed with severe myasthenia
    • Patients who have been diagnosed with narrow-angle glaucoma
    • Patients who have serious hepatic impairment (child class C)
    • Patients who are being treated with a CYP3A4 inhibitor (e.g., Ketoconazole)
    • Patients who have severe renal impairment or who are undergoing hemodialysis
    • Patients who experienced severe side effects after their operation
    • Patients who have diabetic neuropathy
    • Patients who have a significant urinogenital disease such as UTI, interstitial cystitis, urothelial tumor, bladder stone, or urinary retention
    • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
    • Patients who have another medical or psychiatric condition that will make them inappropriate for participate in this study in the opinion of the investigators
    • Patients who have participated in other clinical trials within 30 days before the screening visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747577

Locations
Korea, Republic of
Soul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier: NCT01747577     History of Changes
Other Study ID Numbers: VC-OAB-12-01
Study First Received: December 10, 2012
Last Updated: June 19, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Muscarine antagonist
Prostatectomy
Uroflowmetry

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Urinary Bladder, Overactive
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014