Clinical trial NCT01747577: 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)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Benign Prostate Hyperplasia
Transurethral Resection of Prostate
Photoselective Vaporization Prostatectomy
Keywords: Muscarine antagonist
Prostatectomy
Uroflowmetry
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 68
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 2
timeFrame: Baseline and at week 2
Secondary outcomes:
measure: Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 4
timeFrame: Baseline and at week 4
measure: Change from baseline in IPSS total score
timeFrame: Baseline, at week 2 and at week 4
measure: Changes from baseline in IPSS storage subscale score
timeFrame: Baseline, at week 2 and at week 4
measure: Changes from baseline in IPSS voiding subscale score
timeFrame: Baseline, at week 2 and at week 4
measure: Changes from baseline in individual IPSS scores
timeFrame: Baseline, at week 2 and at week 4
measure: Changes from baseline in IPSS QOL
timeFrame: Baseline, at week 2 and at week 4
measure: Changes from baseline in OABSS total score
timeFrame: Baseline, at week 2 and at week 4
measure: Change from baseline in average number of micturitions per 24 hrs for three days as recorded in the voiding diary
timeFrame: Baseline, at week 2 and at week 4
measure: Safety assessed by the incidence of adverse events, physical exam, and vital signs
timeFrame: For 4 weeks of the treatment
measure: Urinal post voiding residual volume
timeFrame: Before treatment at week 2 and at week 4
measure: Maximum flow rate of the urine
timeFrame: Before treatment at week 2 and at week 4
Other outcomes:
Locations:
city: Soul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: