Overactive Bladder
Conditions
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.
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.
Interventions
DRUGSolifenacin
5mg and 10 mg, oral once daily
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Patient Perception of Bladder Condition Score (PPBC) | 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. |
Participant flow
Recruitment details
Of the planned 100 patients to be enrolled only 36 were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| At Home Titration Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.