Urinary FrequencyPhase 4NCT00826527
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone GreenLight Photoselective Vaporization of the Prostate (PVP)
A Phase 4 study testing Solifenacin PO in people with Urinary Frequency and Urinary Urgency, run by Seattle Urology Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Frequency, Urinary Urgency, Nocturia
- What is being tested?
- Solifenacin PO
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Urology Research Center
Seattle, Washington, 98166
Angel J Felipa, Coordinator, 206-243-3701, surc@comcast.net
Jeffrey M Frankel, MD
About this study
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)
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.
Read the 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.
- Conditions
- Urinary Frequency, Urinary Urgency, Nocturia
- Being tested
- Solifenacin PO
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin PODrug
Tab 5 mg Daily for 12 Weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
Measured: 12 weeks
Secondary outcomes (1)
Change in mean nocturia episodes/24 hours based on 3 day diary
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary FrequencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Urology Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey M Frankel, MD, Principal investigator, Seattle Urology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826527
- Sponsor's protocol ID
- SURC-01-2006
- Status last verified
- Jan 2009
- First submitted
- 20 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00826527
- Acronym / sponsor ID
- SURC-01-2006
- Conditions
- Urinary Frequency, Urinary Urgency, Nocturia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Seattle Urology Research CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (estimated)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solifenacin POTab 5 mg Daily for 12 Weeks | Drug | – |
Primary outcome
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary
Time frame: 12 weeks
1 secondary outcome
Change in mean nocturia episodes/24 hours based on 3 day diary
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Frankel, MD principal investigator
Seattle Urology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin PO in people with Urinary Frequency and Urinary Urgency, run by Seattle Urology Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angel J Felipa, Coordinator (206-243-3701, surc@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of micturitions per 24 hours utilizing a 3 day micturition diary (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009.