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)

NCT01747577 | Completed Phase 4

• 1 other identifier: VC-OAB-12-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Benign Prostate Hyperplasia; Transurethral Resection of Prostate; Photoselective Vaporization Prostatectomy

Keywords

Muscarine antagonist; Prostatectomy; Uroflowmetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  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

Study Arms (2)

Solifenacin group

EXPERIMENTAL

Drug: Solifenacin Succinate

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Solifenacin Succinate DRUG

Oral

Also known as: YM905, Vesicare®

Solifenacin group

Placebo DRUG

Oral

Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Urinary Bladder, Overactive; Prostatic Hyperplasia

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 11, 2012
• Study Start: December 4, 2012
• Primary Completion: October 24, 2013
• Study Completion: October 24, 2013
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)