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CompletedNCT01747577POST-TURPUpdated Nov 7, 2024

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)

A Phase 4 interventional study of Solifenacin Succinate and Placebo in Overactive Bladder, Benign Prostate Hyperplasia and Transurethral Resection of Prostate, sponsored by Astellas Pharma Korea, Inc.. Completed at 1 site in South Korea. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Astellas Pharma Korea, Inc. (part of Astellas Pharma Inc) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Muscarine antagonist
  • Prostatectomy
  • Uroflowmetry
03

In context

Urinary Bladder, Overactive

864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 68 is close to the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Astellas Pharma Korea, Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Browse Astellas Pharma Korea, Inc. studies →All Astellas Pharma Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Solifenacin group

    Drug: Solifenacin Succinate

  • Placebo comparator
    Placebo group

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change from baseline in IPSS total score

    IPSS: International Prostate Symptom Score

    Time frame: Baseline, at week 2 and at week 4

  3. Changes from baseline in IPSS storage subscale score

    Time frame: Baseline, at week 2 and at week 4

  4. Changes from baseline in IPSS voiding subscale score

    Time frame: Baseline, at week 2 and at week 4

  5. Changes from baseline in individual IPSS scores

    Time frame: Baseline, at week 2 and at week 4

  6. Changes from baseline in IPSS QOL

    QOL: Quality of Life

    Time frame: Baseline, at week 2 and at week 4

  7. Changes from baseline in OABSS total score

    OABSS: OverActive Bladder Sympton Score

    Time frame: Baseline, at week 2 and at week 4

  8. 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

  9. Safety assessed by the incidence of adverse events, physical exam, and vital signs

    Time frame: For 4 weeks of the treatment

  10. Urinal post voiding residual volume

    Measured by ultrasound or bladder scan

    Time frame: Before treatment at week 2 and at week 4

  11. Maximum flow rate of the urine

    Assessment using uroflowmetry

    Time frame: Before treatment at week 2 and at week 4

07

Study locations

1 site
  • Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2012 to primary completion in Oct 2013, 10 months.

Of 55 phase 4 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 47. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2012
First posted
Dec 11, 2012
StartActual
Dec 4, 2012
Primary completionActual
Oct 24, 2013
CompletionActual
Oct 24, 2013
Last update
Nov 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01747577
Lead sponsor
Astellas Pharma Korea, Inc.
Responsible party
Sponsor
First posted
Dec 11, 2012
Start date
Dec 4, 2012
Primary completion
Oct 24, 2013
Completion
Oct 24, 2013
Last update
Nov 7, 2024

Study contacts

Medical Director
study director · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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