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TerminatedNCT00759577Updated Oct 26, 2015Results posted

Feasibility of "At-home" Titration of Solifenacin

A Phase 4 interventional study of Solifenacin in Overactive Bladder, sponsored by NYU Langone Health. Terminated. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-26.

Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment

Why this study was terminated
difficulty with enrollment
Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Overactive Bladder
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In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 36 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Other
    Home titration

    Patients were given drug to self titrate

    Drug: Solifenacin

Interventions

  • DrugSolifenacin

    5mg and 10 mg, oral once daily

    Also known as: Vesicare

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What researchers measure

Primary outcomes

  1. Improvement in Patient Perception of Bladder Condition Score (PPBC)

    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.

    Time frame: 12 weeks

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Results

Posted May 30, 2012
Limitations and caveats
Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data.

Participant flow

Of the planned 100 patients to be enrolled only 36 were enrolled.

Participant flow — Overall Study
MilestoneAt Home Titration
Started36
Completed36
Not completed0

Outcome measures

PrimaryImprovement in Patient Perception of Bladder Condition Score (PPBC)

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.

Time frame:
12 weeks

No measurements were reported for this outcome.

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
At Home Titration———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)At Home Titration
Sex: Female, Male
Sex: Female, Male(Participants)At Home Titration
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Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00759577
Lead sponsor
NYU Langone Health
Responsible party
Benjamin Brucker (Clinical Instructor, NYU Langone Health) — Principal investigator
First posted
Sep 25, 2008
Start date
Sep 2008
Primary completion
May 2010
Completion
May 2010
Results posted
May 30, 2012
Last update
Oct 26, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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