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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)

Primary Purpose

Overactive Bladder, Benign Prostate Hyperplasia, Transurethral Resection of Prostate

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Solifenacin Succinate
Placebo
Sponsored by
Astellas Pharma Korea, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Muscarine antagonist, Prostatectomy, Uroflowmetry

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Solifenacin group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 2

Secondary Outcome Measures

Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 4
Change from baseline in IPSS total score
IPSS: International Prostate Symptom Score
Changes from baseline in IPSS storage subscale score
Changes from baseline in IPSS voiding subscale score
Changes from baseline in individual IPSS scores
Changes from baseline in IPSS QOL
QOL: Quality of Life
Changes from baseline in OABSS total score
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
Safety assessed by the incidence of adverse events, physical exam, and vital signs
Urinal post voiding residual volume
Measured by ultrasound or bladder scan
Maximum flow rate of the urine
Assessment using uroflowmetry

Full Information

First Posted
December 10, 2012
Last Updated
July 26, 2022
Sponsor
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01747577
Brief Title
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)
Acronym
POST-TURP
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2012 (Actual)
Primary Completion Date
October 24, 2013 (Actual)
Study Completion Date
October 24, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Korea, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Benign Prostate Hyperplasia, Transurethral Resection of Prostate, Photoselective Vaporization Prostatectomy
Keywords
Muscarine antagonist, Prostatectomy, Uroflowmetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate
Other Intervention Name(s)
YM905, Vesicare®
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Change from baseline in IPSS total score
Description
IPSS: International Prostate Symptom Score
Time Frame
Baseline, at week 2 and at week 4
Title
Changes from baseline in IPSS storage subscale score
Time Frame
Baseline, at week 2 and at week 4
Title
Changes from baseline in IPSS voiding subscale score
Time Frame
Baseline, at week 2 and at week 4
Title
Changes from baseline in individual IPSS scores
Time Frame
Baseline, at week 2 and at week 4
Title
Changes from baseline in IPSS QOL
Description
QOL: Quality of Life
Time Frame
Baseline, at week 2 and at week 4
Title
Changes from baseline in OABSS total score
Description
OABSS: OverActive Bladder Sympton Score
Time Frame
Baseline, at week 2 and at week 4
Title
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
Title
Safety assessed by the incidence of adverse events, physical exam, and vital signs
Time Frame
For 4 weeks of the treatment
Title
Urinal post voiding residual volume
Description
Measured by ultrasound or bladder scan
Time Frame
Before treatment at week 2 and at week 4
Title
Maximum flow rate of the urine
Description
Assessment using uroflowmetry
Time Frame
Before treatment at week 2 and at week 4

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Soul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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."
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=VC-OAB-12-01
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

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)

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