Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency

NCT00979472 | Completed Phase 4

• 1 other identifier: VC-2009-0014
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.

Conditions

Urinary Bladder, Overactive; Overactive Bladder

Keywords

Solifenacin; Overactive bladder; Micturition; Urinary urgency; Vesicare

Outcome Measures

Primary Outcomes (1)

• change of micturition frequency on a 3-day voiding diary

  after 12-week treatment

Secondary Outcomes (3)

• change in patient's perception of bladder condition

  after 12-week treatment

• change in OAB symptom scores

  after 12-week treatment

• patient's satisfaction with the treatment

  after 12-week treatment

Study Arms (2)

with urgency

EXPERIMENTAL

Drug: Solifenacin

without urgency

EXPERIMENTAL

Drug: Solifenacin

Interventions

Solifenacin DRUG

oral

Also known as: YM905, Vesicare

with urgency; without urgency

Eligibility Criteria

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

You may qualify if:

• For the without-urgency group:
• urinary frequency ≥ 8 micturitions per 24 hours no urgency on voiding diary (1 or 2 on a 5 urgency scale)
• For the with-urgency group:
• urinary frequency ≥ 8 micturitions per 24 hours symptoms of urinary urgency≥ 2/day on the voiding diary (3 to 5 on a 5 urgency scale)
• Symptoms lasting for more than 3 months

You may not qualify if:

• Clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test
• Total daily urine volume of \> 3000 mL as verified on the micturition diary before randomization
• Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra
• Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
• Symptomatic acute urinary tract infection (UTI) during the run-in period
• Recurrent UTIs defined as having been treated for symptomatic UTIs \> 4 times in the last year
• Diagnosed or suspected of interstitial cystitis
• Uninvestigated hematuria or hematuria secondary to a malignant disease
• Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care (residual urine\> 100mL of functional bladder capacity)
• Patients with marked cystocele or other clinically significant pelvic prolapse
• Treatment within 14 days preceding randomization, or expected to initiate treatment during the study with:
• Any anticholinergic drugs other than a randomized trial drug
• On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
• Receipt of any electrostimulation or bladder training within 14 days before randomization, or expected to start such treatment during the study
• An indwelling catheter or practicing intermittent self-catheterization

Sponsors & Collaborators

• Asan Medical Center: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (9)

Unknown Facility

Daegu, 700-712, South Korea

Location

Unknown Facility

Daegu, 705-718, South Korea

Location

Unknown Facility

Daejeon, 301-721, South Korea

Location

Unknown Facility

Inchon, 400-711, South Korea

Location

Unknown Facility

Jeonnam, 519-809, South Korea

Location

Unknown Facility

Pusan, 602-739, South Korea

Location

Unknown Facility

Seoul, 135-170, South Korea

Location

Unknown Facility

Seoul, 135-705, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Han JY, Lee KS, Park WH, Park CH, Lee JG, Lee JZ, Kim DY, Na YG, Kwon DD, Choo MS. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014.

  PMID: 25401784 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Myung-Soo Choo, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

KR (9)