Recruiting

SolifenacinEvaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)

Sponsor:

Seattle Urology Research Center

Code:

NCT00826527

Conditions

Urinary Frequency

Urinary Urgency

Nocturia

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Solifenacin PO

Study Details

Brief summary:

The purpose of this study is to demonstrate that solifenacin post-operatively improves irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight laser outpatient procedure.

Conditions

Urinary Frequency

Urinary Urgency

Nocturia

Study ID

NCT00826527

Start date

Jan, 2007

Status verified date

Jan, 2009

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Written informed consent obtained
Male patients greater than 18 years of age with continued OAB symptoms after successful PVP for BPH.
Patients may be included if they have previously been treated with FDA approved anticholinergic agents for the treatment of OAB such as Oxybutynin chloride(generic oxybutynin chloride, Ditropan XL, or Oxytrol) Tolterodine tartrate(Detrol or Detrol LA), or trospium chloride(Santura) and are no longer receiving such treatment for a minimun of 14 days prior to study

Exclusion Criteria:

Previous treatment with darifenacin
Urinary obstruction as defined as a Qmax < 12 ml/sec at time of study entry.
Urinary retention as defined as PVR > 150 ml
Neurogenic Bladder
Prostate Cancer
Chronic inflammation( i.e. interstitial cystitis)
Bladder stones
History of bladder cancer
Urinary tract infection
Uncontrolled narrow-angle glaucoma
Gastric retention
History of diagnosed gastro-intestinal obstructive disease.
Severe renal or hepatic impairment
Concomitant anticholinergic or antispasmodic medications.
Known or suspected hypersensitivity to Solifenacin, any of its components (lactose monohydrate, corn starch, hydromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 ant titanium dioxide with yellow ferric oxide(5 mg tablet) or red ferric oxide(10 mg tablet, or other anticholinergics.
Participation in any clinical trial involving an investigational drug, within 30 days prior to enrollment.
Any clinical condition, which in the opinion of the investigator, would not allow safe completion of the study.

Study Design

Enrollment

23 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Solifenacin PO

Tab 5 mg Daily for 12 Weeks

Primary outcome measure

Change in number of micturitions per 24 hours utilizing a 3 day micturition diary [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Angel J Felipa, Coordinator

206-243-3701 surc@comcast.net

Locations

Seattle Urology Research Center

Recruiting

Seattle, Washington, United States, 98166

Contacts

Angel J Felipa, Coordinator

206-243-3701 surc@comcast.net

Principal Investigator:

Jeffrey M Frankel, MD

More Information

Sponsor

Seattle Urology Research Center

Last update posted

Jan 22, 2009

Last verified

Jan, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Urology Research Center on 2009-01-22.