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Overactive BladderPhase 4POST-TURPNCT01747577

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 study testing Solifenacin Succinate in people with Overactive Bladder and Benign Prostate Hyperplasia, run by Astellas Pharma Korea, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Solifenacin Succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteSouth Korea
Study dates
4 Dec 2012to 24 Oct 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Solifenacin Succinate, Placebo
Keywords
Muscarine antagonist, Prostatectomy, Uroflowmetry
Medical subject headings
Urinary Bladder, Overactive, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solifenacin SuccinateDrug

    Also called YM905, Vesicare®

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT01747577
Study groupRoleWhat they receive
Solifenacin groupExperimentalNot described
Receives: Drug: Solifenacin Succinate
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and at week 2

Secondary outcomes (11)

  1. Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 4

    Measured: Baseline and at week 4

  2. Change from baseline in IPSS total score

    IPSS: International Prostate Symptom Score

    Measured: Baseline, at week 2 and at week 4

  3. Changes from baseline in IPSS storage subscale score

    Measured: Baseline, at week 2 and at week 4

  4. Changes from baseline in IPSS voiding subscale score

    Measured: Baseline, at week 2 and at week 4

  5. Changes from baseline in individual IPSS scores

    Measured: Baseline, at week 2 and at week 4

  6. Changes from baseline in IPSS QOL

    QOL: Quality of Life

    Measured: Baseline, at week 2 and at week 4

  7. Changes from baseline in OABSS total score

    OABSS: OverActive Bladder Sympton Score

    Measured: 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

    Measured: Baseline, at week 2 and at week 4

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

    Measured: For 4 weeks of the treatment

  10. Urinal post voiding residual volume

    Measured by ultrasound or bladder scan

    Measured: Before treatment at week 2 and at week 4

  11. Maximum flow rate of the urine

    Assessment using uroflowmetry

    Measured: Before treatment at week 2 and at week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study start4 Dec 2012
  3. Primary completion24 Oct 2013
  4. Study completion24 Oct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01747577
Sponsor's protocol ID
VC-OAB-12-01
Acronym
POST-TURP
Status last verified
Oct 2024
First submitted
10 Dec 2012
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Solifenacin Succinate in people with Overactive Bladder and Benign Prostate Hyperplasia, run by Astellas Pharma Korea, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01747577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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