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

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ClinicalTrials.gov Identifier: NCT00826527
Recruitment Status : Unknown
Verified January 2009 by Seattle Urology Research Center.
Recruitment status was:  Recruiting
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
Sponsor:
Information provided by:
Seattle Urology Research Center

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.

Condition or disease Intervention/treatment Phase
Urinary Frequency Urinary Urgency Nocturia Drug: Solifenacin PO Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2007
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Solifenacin PO
    Tab 5 mg Daily for 12 Weeks


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

Secondary Outcome Measures :
  1. Change in mean nocturia episodes/24 hours based on 3 day diary [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jeffrey M. Frankel, MD, Seattle Urology Research Center
ClinicalTrials.gov Identifier: NCT00826527     History of Changes
Other Study ID Numbers: SURC-01-2006
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents