Trial Outcomes & Findings for The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB) (NCT NCT01533597)

NCT ID: NCT01533597

Last Updated: 2015-01-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: at week 24 relative to baseline
• Results posted on: 2015-01-27

Participant Flow

Participant milestones

Measure	Solifenacin Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Overall Study STARTED	35	35
Overall Study COMPLETED	29	25
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)

Baseline characteristics by cohort

Measure	Solifenacin n=35 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=35 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)	Total n=70 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
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	52.1 years STANDARD_DEVIATION 8.2 • n=5 Participants	52.3 years STANDARD_DEVIATION 13.8 • n=7 Participants	52.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: at week 24 relative to baseline

Outcome measures

Measure	Solifenacin n=29 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=25 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Change in Mean Number of Micturition Episodes Per 24 Hours	-1.9 episodes Interval -2.5 to -1.2	-2.2 episodes Interval -3.0 to -1.4

SECONDARY outcome

Timeframe: at week 24 relative to baseline

Outcome measures

Measure	Solifenacin n=29 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=25 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Numeric Change of Urgency Episodes Per 24 Hours	-2.4 episodes Interval -3.6 to -1.2	-2.1 episodes Interval -2.7 to -1.5

SECONDARY outcome

Timeframe: at week 24 relative to baseline

Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)

Outcome measures

Measure	Solifenacin n=29 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=25 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Change in Total Score of OABSS	-3.1 units on a scale Interval -4.2 to -2.0	-3.5 units on a scale Interval -4.3 to -2.7

SECONDARY outcome

Timeframe: at week 24 relative to baseline

Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.

Outcome measures

Measure	Solifenacin n=29 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=25 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Change in Score of IPSS	-7.7 units on a scale Interval -10.4 to -5.1	-8.3 units on a scale Interval -10.3 to -6.3

SECONDARY outcome

Timeframe: at week 24 relative to baseline

Change from baseline in Post-Void Residual (PVR) volume

Outcome measures

Measure	Solifenacin n=29 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=25 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Change of PVR	13.2 mL Interval 8.7 to 17.6	10.8 mL Interval 6.9 to 14.7

SECONDARY outcome

Timeframe: at week 24 relative to baseline

maximal urinary flow rate (Qmax) assessed by uroflowmetry

Outcome measures

Measure	Solifenacin n=29 Participants Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=25 Participants Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Change of Qmax	1.1 mL/sec Interval -0.6 to 2.7	2.1 mL/sec Interval -0.5 to 4.8

Adverse Events

Solifenacin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Solifenacin Plus Tamsulosin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Solifenacin n=35 participants at risk Solifenacin: Solifenacin (5mg, qd, oral)	Solifenacin Plus Tamsulosin n=35 participants at risk Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Gastrointestinal disorders constipation	0.00% 0/35 • 24weeks	2.9% 1/35 • 24weeks
Endocrine disorders dry mouth	5.7% 2/35 • 24weeks	2.9% 1/35 • 24weeks

Additional Information

Dr. Kwang-Woo Lee

Soonchunhyang Bucheon Hospital

Phone: +82 32 621 5465

Email: urolkw@schmc.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place