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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Seattle Urology Research Center. Recruitment status was Recruiting

First Received on January 20, 2009. Last Updated on January 21, 2009 History of Changes

Sponsor:	Seattle Urology Research Center
Information provided by:	Seattle Urology Research Center
ClinicalTrials.gov Identifier:	NCT00826527

Purpose

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.

Condition	Intervention	Phase
Urinary Frequency Urinary Urgency Nocturia	Drug: Solifenacin PO	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)for the Treatment of Clinically Significant Benign Prostate Hyperplasia (BPH)

Resource links provided by NLM:

Drug Information available for: Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Seattle Urology Research Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Change in mean nocturia episodes/24 hours based on 3 day diary [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	23
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Tab 5 mg Daily for 12 Weeks

Detailed Description:

Obstruction of the urinary tract secondary to benign prostatic hyperplasia can result in both obstructive and irritative urinary symptoms. In the last few years, photovaporization of the prostate has emerged as a popular teatment for this problem. This outpatient procedure uses a GeenLight KTP laser manufactured by Laserscope to vaporize the obstructing aspects of the prostatic urethral tissue to create a central cavity. After obstruction is relieved , it is not uncommon for a patient to be left with the irritative symptoms of frequency, urgency and nocturia, either from the procedure itself in the short-term or due to changes that develop in the bladder due to the long-standing obstruction. Clinical experience with this procedure indicates that after the mechanical obstruction of the prostate is relieved, medical therapy with an antimuscarinic agent should be able to alleviate these irritative urinary symptoms without the risk of urinary retention. By adding solifenacin in the early post operative period ( 2-12 weeks)for the subset of patients still experiencing irritative symptoms, further improvements in bladder symptoms my be achieved.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826527

Contacts

Contact: Angel J Felipa, Coordinator

206-243-3701

surc@comcast.net

Locations

United States, Washington
Seattle Urology Research Center	Recruiting
Seattle, Washington, United States, 98166
Contact: Angel J Felipa, Coordinator 206-243-3701 surc@comcast.net
Principal Investigator: Jeffrey M Frankel, MD

Sponsors and Collaborators

Seattle Urology Research Center

Investigators

Principal Investigator:

Jeffrey M Frankel, MD

Seattle Urology Research Center

More Information

No publications provided

Responsible Party:	Jeffrey M. Frankel, MD, Seattle Urology Research Center
ClinicalTrials.gov Identifier:	NCT00826527 History of Changes
Other Study ID Numbers:	SURC-01-2006
Study First Received:	January 20, 2009
Last Updated:	January 21, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Prostatic Hyperplasia
Nocturia
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate

Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012