Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT01042236

First received: January 4, 2010

Last updated: July 20, 2011

Last verified: July 2011

History of Changes

Results First Received: June 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Stress Urinary Incontinence
Intervention:	Drug: Fesoterodine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants randomized to receive sequenced dosing of Fesoterodine 4 milligrams (mg) (A), or Fesoterodine 8 milligrams (B), or Placebo matching study treatment (C). Each dosed for 7 days with a 7 day washout between dosing periods. Dosing sequenced as ABC, ACB, BAC, BCA, CAB, or CBA.

Reporting Groups

	Description
Sequence ABC	Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
Sequence BCA	Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
Sequence CAB	Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
Sequence ACB	Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
Sequence BAC	Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
Sequence CBA	Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.

Participant Flow for 3 periods

Period 1: Treatment Period 1

	Sequence ABC	Sequence BCA	Sequence CAB	Sequence ACB	Sequence BAC	Sequence CBA
STARTED	3	4	3	5	4	3
COMPLETED	3	3	3	5	3	3
NOT COMPLETED	0	1	0	0	1	0
Adverse Event	0	1	0	0	1	0

Period 2: Treatment Period 2

	Sequence ABC	Sequence BCA	Sequence CAB	Sequence ACB	Sequence BAC	Sequence CBA
STARTED	3	3	3	5	3	3
COMPLETED	3	3	3	5	3	3
NOT COMPLETED	0	0	0	0	0	0

Period 3: Treatment Period 3

	Sequence ABC	Sequence BCA	Sequence CAB	Sequence ACB	Sequence BAC	Sequence CBA
STARTED	3	3	3	5	3	3
COMPLETED	3	3	3	3	3	3
NOT COMPLETED	0	0	0	2	0	0
Adverse Event	0	0	0	1	0	0
Protocol Violation	0	0	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	22
Age [units: Years] Mean ± Standard Deviation	47.9 ± 8.4
Gender [units: Participants]
Female	22
Male	0

Outcome Measures

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1. Primary:

Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 [ Time Frame: Baseline, Day 7 of each period ]

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2. Secondary:

Change From Baseline in Closing Urethral Pressure at Day 7 [ Time Frame: Baseline, Day 7 of each period ]

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3. Secondary:

Change From Baseline in Opening Urethral Elastance at Day 7 [ Time Frame: Baseline, Day 7 of each period ]

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4. Secondary:

Change From Baseline in Closing Urethral Elastance at Day 7 [ Time Frame: Baseline, Day 7 of each period ]

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5. Secondary:

Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ]

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6. Secondary:

Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ]

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7. Secondary:

Stress Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ]

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8. Secondary:

Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ]

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9. Secondary:

Urgency Urinary Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ]

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10. Secondary:

Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ]

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11. Secondary:

Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration [ Time Frame: Baseline, Day 7 of each period ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01042236 History of Changes
Other Study ID Numbers:	A0221064
Study First Received:	January 4, 2010
Results First Received:	June 8, 2011
Last Updated:	July 20, 2011
Health Authority:	Denmark: Danish Medical Authority

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