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)

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Benign Prostate Hyperplasia; Transurethral Resection of Prostate; Photoselective Vaporization Prostatectomy
• Intervention / Treatment: Drug: Placebo; Drug: Solifenacin Succinate

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Soul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; Oral
Experimental: Solifenacin group	Drug: Solifenacin Succinate; Oral; Other Names: YM905; Vesicare®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 2	Baseline and at week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 4		Baseline and at week 4
Change from baseline in IPSS total score	IPSS: International Prostate Symptom Score	Baseline, at week 2 and at week 4
Changes from baseline in IPSS storage subscale score		Baseline, at week 2 and at week 4
Changes from baseline in IPSS voiding subscale score		Baseline, at week 2 and at week 4
Changes from baseline in individual IPSS scores		Baseline, at week 2 and at week 4
Changes from baseline in IPSS QOL	QOL: Quality of Life	Baseline, at week 2 and at week 4
Changes from baseline in OABSS total score	OABSS: OverActive Bladder Sympton Score	Baseline, at week 2 and at week 4
Change from baseline in average number of micturitions per 24 hrs for three days as recorded in the voiding diary		Baseline, at week 2 and at week 4
Safety assessed by the incidence of adverse events, physical exam, and vital signs		For 4 weeks of the treatment
Urinal post voiding residual volume	Measured by ultrasound or bladder scan	Before treatment at week 2 and at week 4
Maximum flow rate of the urine	Assessment using uroflowmetry	Before treatment at week 2 and at week 4

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2012
• Primary Completion (Actual): October 24, 2013
• Study Completion (Actual): October 24, 2013

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Prostatectomy; Muscarine antagonist; Uroflowmetry
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: VC-OAB-12-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."