NCT01533597

Brief Summary

The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 27, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

February 2, 2012

Results QC Date

January 11, 2015

Last Update Submit

January 24, 2015

Conditions

Overactive Bladder

Keywords

Overactive bladderSolifenacin succinateTamsulosin

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Number of Micturition Episodes Per 24 Hours

    at week 24 relative to baseline

Secondary Outcomes (5)

  • Numeric Change of Urgency Episodes Per 24 Hours

    at week 24 relative to baseline

  • Change in Total Score of OABSS

    at week 24 relative to baseline

  • Change in Score of IPSS

    at week 24 relative to baseline

  • Change of PVR

    at week 24 relative to baseline

  • Change of Qmax

    at week 24 relative to baseline

Study Arms (2)

Solifenacin

ACTIVE COMPARATOR
Drug: Solifenacin

Solifenacin plus Tamsulosin

EXPERIMENTAL
Drug: Solifenacin plus Tamsulosin

Interventions

SolifenacinDRUG

Solifenacin (5mg, qd, oral)

Also known as: Vesicare
Solifenacin
Solifenacin plus TamsulosinDRUG

Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)

Also known as: Vesicare, Harnal
Solifenacin plus Tamsulosin

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female aged 20 ≤ and \< 70 years
  • History of OAB symptoms for ≥ 3 months
  • International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
  • An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

You may not qualify if:

  • Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
  • Any condition that would contraindicate their usage of anticholinergics or alpha blockers
  • History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
  • History of stress urinary incontinence or urinary retention
  • History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
  • Pregnant or nursing women
  • Current urinary tract infection
  • Neurological bladder dysfunction
  • Treatment with drugs that may interfere with CYP3A4 metabolic function
  • Significant hepatic or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin SuccinateTamsulosin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Limitations and Caveats

small study population

Results Point of Contact

Title
Dr. Kwang-Woo Lee
Organization
Soonchunhyang Bucheon Hospital
urolkw@schmc.ac.kr
+82 32 621 5465

Study Officials

  • Kwang Woo Lee, Ph.D

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Clinical Professor

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 15, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

January 27, 2015

Results First Posted

January 27, 2015

Record last verified: 2015-01

Locations

KR(1)