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Feasibility of "At-home" Titration of Solifenacin

Primary Purpose

Overactive Bladder

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Solifenacin

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Ambulatory male or female patients aged ≥18 years of age and able to use the toilet without difficulty.
Symptoms of OAB for > 3 months.
Written informed consent (IC) has been obtained.
Capable of filling out questionnaires.
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.
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.
Normal urine analysis or sterile urine specimen (culture negative)

Exclusion Criteria:

Previous treatment with darifenacin
Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
Evidence of a urinary tract infection (UTI); chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction (benign prostatic hyperplasia [BPH]) as determined by the Investigator.
Uncontrolled narrow angle glaucoma, urinary or gastric retention
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.
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.
A history of bladder cancer
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.
Participation in any clinical trial (except patient registry trial) involving an investigational drug, within 30 days prior to enrollment
Patients with chronic severe constipation or history of diagnosed gastrointestinal disease obstruction.
Patients with hematuria.
Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Home titration

Arm Description

Patients were given drug to self titrate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00759577

First Posted

September 24, 2008

Last Updated

October 5, 2015

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT00759577

Brief Title

Feasibility of "At-home" Titration of Solifenacin

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

difficulty with enrollment

Study Start Date

September 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NYU Langone Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home titration

Arm Type

Other

Arm Description

Patients were given drug to self titrate

Intervention Type

Drug

Intervention Name(s)

Solifenacin

Other Intervention Name(s)

Vesicare

Intervention Description

5mg and 10 mg, oral once daily

Primary Outcome Measure Information:

Title

Improvement in Patient Perception of Bladder Condition Score (PPBC)

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory male or female patients aged ≥18 years of age and able to use the toilet without difficulty. Symptoms of OAB for > 3 months. Written informed consent (IC) has been obtained. Capable of filling out questionnaires. 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. 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. Normal urine analysis or sterile urine specimen (culture negative) Exclusion Criteria: Previous treatment with darifenacin Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator Evidence of a urinary tract infection (UTI); chronic inflammation such as interstitial cystitis and bladder stones Clinically significant outflow obstruction (benign prostatic hyperplasia [BPH]) as determined by the Investigator. Uncontrolled narrow angle glaucoma, urinary or gastric retention 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. 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. A history of bladder cancer 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. Participation in any clinical trial (except patient registry trial) involving an investigational drug, within 30 days prior to enrollment Patients with chronic severe constipation or history of diagnosed gastrointestinal disease obstruction. Patients with hematuria. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.

12. IPD Sharing Statement

Learn more about this trial

Feasibility of "At-home" Titration of Solifenacin

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