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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)

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
Sponsor:
Information provided by:
Seattle Urology Research Center
ClinicalTrials.gov Identifier:
NCT00826527
First received: January 20, 2009
Last updated: January 21, 2009
Last verified: January 2009
  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 4

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:


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:
    Drug: Solifenacin PO
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Solifenacin
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 27, 2014