NCT00602186

Brief Summary

The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Status
unknown

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

July 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

January 29, 2008

Status Verified

January 1, 2008

Enrollment Period

1.7 years

First QC Date

April 18, 2007

Last Update Submit

January 26, 2008

Conditions

Neurogenic Bladder

Keywords

female voiding dysfunctionTamsolusinprazosin

Outcome Measures

Primary Outcomes (1)

  • patient symptoms improvement(Standard questionare)

    every month untile 3 months

Secondary Outcomes (1)

  • Urodynamics parameters improvement

    three months later

Study Arms (2)

1

EXPERIMENTAL

taking Tamsulosin

Drug: tamsolusin

2

ACTIVE COMPARATOR

taking prasosin

Drug: prazosin

Interventions

tamsolusinDRUG

0.4 mg /day

Also known as: Flomax
1
prazosinDRUG

1 mg/day

2

Eligibility Criteria

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

You may qualify if:

  • Healthy females with voiding difficulty with MFR\<12 and post void residual urine\>50cc

You may not qualify if:

  • History of pelvic floor surgury during last 3 month
  • Any contraindication for Tamsolusin or prazosin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

TamsulosinPrazosin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • SAKINEH hajebrahimi, MD

    Urology department ofTabriz University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

January 28, 2008

Study Start

July 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2008

Last Updated

January 29, 2008

Record last verified: 2008-01