Trial Outcomes & Findings for Mixed Incontinence: Medical Or Surgical Approach? (NCT NCT00803270)

Results Overview

Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

6 Months

Results posted on

2013-05-10

Participant Flow

40 women were screened, 29 met eligibility criteria and 27 were enrolled between November, 2008 and March, 2009. The trial was terminated in March 2009 due to inadequate enrollment.

All enrolled participants were randomized.

Participant milestones

Participant milestones
Measure	Surgical Treatment Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.	Non Surgical Treatment The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and 2. Behavioral therapy.
Overall Study STARTED	13	14
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgical Treatment Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.	Non Surgical Treatment The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and 2. Behavioral therapy.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Mixed Incontinence: Medical Or Surgical Approach?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Treatment n=13 Participants Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.	Non Surgical Treatment n=14 Participants The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved OAB drug in approved doses; and 2. Behavioral therapy.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	11 Participants n=4 Participants	19 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Age Continuous	53 years STANDARD_DEVIATION 14 • n=93 Participants	59 years STANDARD_DEVIATION 14 • n=4 Participants	56 years STANDARD_DEVIATION 14 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	14 participants n=4 Participants	27 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Participants who attended 6 month follow-up visit

Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".

Outcome measures

Outcome measures
Measure	Surgical Treatment n=12 Participants Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.	Non Surgical Treatment n=12 Participants The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved OAB drug in approved doses; and 2. Behavioral therapy.
Optimal Outcome of Treatment at 6 Months	9 participants	8 participants

SECONDARY outcome

Timeframe: 3 months

Population: Participants who attended 3 month follow-up visit

Composite measure defined as "much better" or "very much better" om PGI-I and "normal" or "mild" on PGI-S. PGI-I is a single item: "Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment" with responses ranging from 1="Very much better" to 7="Very much worse." PGI-S is a single items: "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1="Normal" to 4="Severe."

Outcome measures

Outcome measures
Measure	Surgical Treatment n=10 Participants Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.	Non Surgical Treatment n=12 Participants The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved OAB drug in approved doses; and 2. Behavioral therapy.
Optimal Outcome of Treatment at 3 Months	7 participants	3 participants

Adverse Events

Surgical Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Non Surgical Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Surgical Treatment n=14 participants at risk Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.	Non Surgical Treatment n=13 participants at risk The non-surgical treatment will include two components: 1. Pharmacological therapy with any FDA approved OAB drug in approved doses; and 2. Behavioral therapy.
Renal and urinary disorders Bladder perforation	7.1% 1/14 • Number of events 1 • 6 months	0.00% 0/13 • 6 months
Renal and urinary disorders Urinary retention	0.00% 0/14 • 6 months	7.7% 1/13 • Number of events 1 • 6 months

Additional Information

Anne M. Stoddard

New England Resesarch Institutes

Phone: 617-972-3331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER