Feasibility of "At-home" Titration of Solifenacin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759577
Recruitment Status : Terminated (difficulty with enrollment)
First Posted : September 25, 2008
Results First Posted : May 30, 2012
Last Update Posted : October 26, 2015
Information provided by (Responsible Party):
Benjamin Brucker, New York University School of Medicine

Brief Summary:
This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Solifenacin Phase 4

Detailed Description:
Open-label single center trial to study improvements in symptom bother and quality of life in OAB patients self titrating solifenacin 5mg and 10 mg. The study was designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. After eligibility was confirmed, subjects completed a number of questionnaires which include patient perception of bladder condition (PPBC)12, Overactive Bladder Questionaire (OAB-q13), visual analog scale (VAS) 0-100 assessing bother of urge incontinence, urgency, frequency and nocturia over the past week.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of "At-home" Titration of Solifenacin 5 and 10mg and Effect on Symptoms and Quality of Life in a Typical OAB Population
Study Start Date : September 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Home titration
Patients were given drug to self titrate
Drug: Solifenacin
5mg and 10 mg, oral once daily
Other Name: Vesicare

Primary Outcome Measures :
  1. Improvement in Patient Perception of Bladder Condition Score (PPBC) [ Time Frame: 12 weeks ]
    Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Ambulatory male or female patients aged ≥18 years of age and able to use the toilet without difficulty.
  2. Symptoms of OAB for > 3 months.
  3. Written informed consent (IC) has been obtained.
  4. Capable of filling out questionnaires.
  5. Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also 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®, Ditropan®, or OxytrolTM), tolterodine tartrate (Detrol® or Detrol LA®), or trospium chloride (Sanctura®, Sanctura XR®) and are no longer receiving such treatment for at least 14 days.
  6. Patients undergoing non-medical treatments for OAB (pelvic floor exercises or any behavioral modification) must have had treatment initiated at least 4 weeks prior to enrollment and should not change regimen.
  7. Normal urine analysis or sterile urine specimen (culture negative)

Exclusion Criteria:

  1. Previous treatment with darifenacin
  2. Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
  3. Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
  4. Evidence of a urinary tract infection (UTI); chronic inflammation such as interstitial cystitis and bladder stones
  5. Clinically significant outflow obstruction (benign prostatic hyperplasia [BPH]) as determined by the Investigator.
  6. Uncontrolled narrow angle glaucoma, urinary or gastric retention
  7. All patients with severe renal or hepatic impairment will be excluded from the trial; dose increases to 10mg are not permitted for patients that have moderate hepatic impairment as evidenced by liver function testing.
  8. Women of childbearing potential who are pregnant or intend to become pregnant during the study or who are sexually active and practicing an unreliable method of birth control, as judged by the Investigator, or will be lactating during the study.
  9. A history of bladder cancer
  10. Known or suspected hypersensitivity to solifenacin succinate, any of its components (lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide [5mg tablet] or red ferric oxide [10 mg tablet]), or other anticholinergics.
  11. Participation in any clinical trial (except patient registry trial) involving an investigational drug, within 30 days prior to enrollment
  12. Patients with chronic severe constipation or history of diagnosed gastrointestinal disease obstruction.
  13. Patients with hematuria.
  14. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.

Responsible Party: Benjamin Brucker, Clinical Instructor, New York University School of Medicine Identifier: NCT00759577     History of Changes
Other Study ID Numbers: VESI-8E01
First Posted: September 25, 2008    Key Record Dates
Results First Posted: May 30, 2012
Last Update Posted: October 26, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
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