Trial Outcomes & Findings for Validation of a Real-time Urodynamic Measure of Urinary Urgency (NCT NCT00909428)

Results Overview

At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

30 Days

Results posted on

2017-05-24

Participant Flow

Fifty-one individuals were consented and 42 women with overactive bladder (OAB) received study drug between January 2007 and February 2009. Participants were recruited using physician solicitation.

Following informed consent, nine women were negative for OAB and did not receive solifenacin succinate

Participant milestones

Participant milestones
Measure	Detrusor Overactivity Incontinence (DOI) Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).	Urodynamic Stress Incontinence (USI) Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)	Mixed Incontinence (DOI-USI) Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
Overall Study STARTED	18	15	9
Overall Study COMPLETED	5	5	0
Overall Study NOT COMPLETED	13	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Detrusor Overactivity Incontinence (DOI) Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).	Urodynamic Stress Incontinence (USI) Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)	Mixed Incontinence (DOI-USI) Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
Overall Study Lost to Follow-up	13	10	9

Baseline Characteristics

Validation of a Real-time Urodynamic Measure of Urinary Urgency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detrusor Overactivity Incontinence (DOI) n=18 Participants Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)	Urodynamic Stress Incontinence (USI) n=15 Participants Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)	Mixed Incontinence (DOI-USI) n=9 Participants Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	34 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis.

At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.

Outcome measures

Outcome measures
Measure	Baseline Maximal Cystometric Capacity n=10 Participants All patients with DOI or USI had their baseline maximal cystometric capacity recorded	One Month Maximal Cystometric Capacity n=10 Participants All patients with DOI or USI had their maximal cystometric capacity recorded following 30 days of treatment with daily 10mg solifenacin succinate.
Change in Maximal Cystometric Capacity (mL)	95 milliliters (mL) Interval 0.0 to 99.25	473.50 milliliters (mL) Interval 416.75 to 549.5

Adverse Events

Detrusor Overactivity Incontinence (DOI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Urodynamic Stress Incontinence (USI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mixed Incontinence (DOI-USI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary P FitzGerald

Loyola University Chicago

Phone: 708-216-2170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place