Feasibility of "At-home" Titration of Solifenacin

NCT00759577 | Terminated Phase 4 Results DMC

• 1 other identifier: VESI-8E01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder

Outcome Measures

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.

  12 weeks

Study Arms (1)

Home titration

OTHER

Patients were given drug to self titrate

Drug: Solifenacin

Interventions

Solifenacin DRUG

5mg and 10 mg, oral once daily

Also known as: Vesicare

Home titration

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Dr. Victor Nitti
• Organization: New York University

Victor.Nitti@NYUMC.org

646 825 6300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 26, 2015
• Results First Posted: May 30, 2012

Record last verified: 2015-10