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

NCT00605319 | Completed Phase 4 Results

• 2 other identifiers: 05060079342005-0202
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Outlet Obstruction

Keywords

BPH; BOO

Outcome Measures

Primary Outcomes (7)

• IPSS Obstructive

  International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with obstructive symptoms which includes hesitancy or difficulty initiating the stream, straining to void, a reduced flow, an intermittent stream or a sensation of incomplete emptying.

  screening (Month 0), 2-months, 3-months, 7-months

• IPSS Irritative

  International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with irritative symptoms which includes frequency, urgency, nocturia and urge incontinence

  screening (Month 0), 2-months, 3-months, 7-months

• IPSS Nocturia

  International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with nocturia meaning individuals who wake up during sleeping hours to urinate.

  screening (Month 0), 2-months, 3-months, 7-months

• International Prostate Symptom Score (IPSS) Quality of Life (QoL)

  IPSS Quality of Life (QoL) is one question used to assess how the patient's symptoms affect their quality of life. A score ranges from 1 to 6, with 6 being the worse outcome.

  screening (Month 0), 2-months, 3-months, 7-months

• Maximum Flow Rate (Qmax)

  Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary

  screening (Month 0), 2-months, 3-months, 7-months

• Average Flow Rate (Qavg)

  Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time

  screening (Month 0), 2-months, 3-months, 7-months

• Postvoid Residual Volume (PVR)

  Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.

  screening (Month 0), 2-months, 3-months, 7-months

Study Arms (1)

Toviaz (Fesoterodine)

OTHER

Toviaz 4mg to 8mg

Drug: Toviaz (Fesoterodine)

Interventions

Toviaz (Fesoterodine) DRUG

4mg to 8mg by mouth once daily

Also known as: Toviaz

Toviaz (Fesoterodine)

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pfizer: collaborator

Study Sites (1)

New York Hospital, Cornell University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases

Limitations and Caveats

Small Sample size and the nonrandomized and nonblinded administration of the drug.

Results Point of Contact

• Title: Dr. Alexis Te
• Organization: Weill Cornell Medical College

aet2005@med.cornell.edu

646-962-4811

Study Officials

• Alexis Te, MD

  Cornell University

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 10, 2018
• Results First Posted: April 10, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)