Phase 4 N=17 Treatment

An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia

Bladder Outlet Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT00605319 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: IPSS Obstructive — 9.1; 7.5; 8.4; 7.9 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Toviaz (Fesoterodine) (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: Weill Medical College of Cornell University
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY IPSS Obstructive	9.1; 7.5; 8.4; 7.9	—
PRIMARY IPSS Irritative	6.6; 5.6; 5.1; 4.4	—
PRIMARY IPSS Nocturia	3.2; 2.8; 2.6; 2.6	—
PRIMARY International Prostate Symptom Score (IPSS) Quality of Life (QoL)	4.2; 3.8; 3.5; 3.5	—
PRIMARY Maximum Flow Rate (Qmax)	15.3; 10.2; 10.6; 10.5	—
PRIMARY Average Flow Rate (Qavg)	NA; 5.1; 6.1; 6.2	—
PRIMARY Postvoid Residual Volume (PVR)	42.9; 33.1; 48.2; 55.2	—

Summary

The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study.

Eligibility Criteria

Patients will be selected by the investigator and sub-investigator's patient population, and physician referrals. All patients will meet the inclusion/ exclusion criteria.

Inclusion Criteria

Male ≥40 years of age
Clinical signs and symptoms of frequency and urgency, enlarged prostate and urodynamic study consistent with overactive bladder.
IPSS >12, with IPSS QoL > 3 at screening visit.
Ability and willingness to correctly complete the micturition diary and all the trial related questionnaires comply with scheduled visits and comply with trial procedures.
Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
Procedure to treat BOO by TURP or PVP greater than or equal to 1 month ago.

Exclusion Criteria

A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet obstruction due to: mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
Evidence of Urinary Tract Infection according to local standard of care.
Expectation of initiating treatment during the duration of this study with - any drug treatment for OAB, any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects.
Use of any electrostimulation within the 30 days before randomization, or the expectation to initiate such therapy during the study.
Any condition which, in the opinion of the investigator, makes the patient unstable, or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma, urinary retention, preplanned prostate surgery, or gastric retention.
Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine.
Use of any other investigational drug in the 2 months preceding visit 1.
History of postural hypotension or syncope in the judgement of the investigator based on local standards of care.
Alcohol and/or any other drug abuse in the opinion of the investigator.
Medications such as erythromycin, Biaxin (Clarithromycin), Sporanox (itraconazole), Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine) and miconazole.
Non-medication treatments such as bio-feedback or other bladder training exercises.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00605319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.