Trial Outcomes & Findings for The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms (NCT NCT01530243)

Results Overview

LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

104 participants

Primary outcome timeframe

Expected average of 2 weeks

Results posted on

2015-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo: same as tolterodine and terazosin dose	Terazosin Terazosin: 2 mg BID	Tolterodine Tolterodine: 2 mg daily	Tolterodine + Terazosin Tolterodine + Terazosin: 2mg daily and 2mg BID
Overall Study STARTED	26	26	26	26
Overall Study COMPLETED	24	23	23	24
Overall Study NOT COMPLETED	2	3	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=24 Participants Placebo: same as tolterodine and terazosin dose	Terazosin n=23 Participants Terazosine: 2 mg BID	Tolterodine n=23 Participants Tolterodine: 2 mg daily	Tolterodine + Terazosin n=24 Participants Tolterodine + Terazosin: 2mg daily and 2mg BID	Total n=94 Participants Total of all reporting groups
Age, Continuous	33.37 years STANDARD_DEVIATION 9.58 • n=93 Participants	38.35 years STANDARD_DEVIATION 9.23 • n=4 Participants	37.04 years STANDARD_DEVIATION 9.04 • n=27 Participants	35.75 years STANDARD_DEVIATION 9.38 • n=483 Participants	36.53 years STANDARD_DEVIATION 9.53 • n=36 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	7 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants	19 Participants n=36 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	16 Participants n=4 Participants	19 Participants n=27 Participants	19 Participants n=483 Participants	75 Participants n=36 Participants
Region of Enrollment Iran, Islamic Republic of	24 participants n=93 Participants	23 participants n=4 Participants	23 participants n=27 Participants	24 participants n=483 Participants	94 participants n=36 Participants

PRIMARY outcome

Timeframe: Expected average of 2 weeks

Population: The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.

LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Placebo: same as tolterodine and terazosin dose	Terazosin n=23 Participants Terazosine: 2 mg BID	Tolterodine n=23 Participants Tolterodine: 2 mg daily	Tolterodine + Terazosin n=24 Participants Tolterodine + Terazosin: 2mg daily and 2mg BID
Lower Urinary Tract Symptoms (LUTS)	11.12 units on a scale Standard Deviation 7.84	4.39 units on a scale Standard Deviation 6.03	7.21 units on a scale Standard Deviation 6.57	5.58 units on a scale Standard Deviation 4.82

SECONDARY outcome

Timeframe: Expected 2 weeks later

The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Placebo: same as tolterodine and terazosin dose	Terazosin n=23 Participants Terazosine: 2 mg BID	Tolterodine n=23 Participants Tolterodine: 2 mg daily	Tolterodine + Terazosin n=24 Participants Tolterodine + Terazosin: 2mg daily and 2mg BID
Quality of Life	3.37 units on a scale Standard Deviation 2.16	2 units on a scale Standard Deviation 2.25	2.30 units on a scale Standard Deviation 1.89	0.95 units on a scale Standard Deviation 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Expected 2 weeks later

The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Placebo: same as tolterodine and terazosin dose	Terazosin n=23 Participants Terazosine: 2 mg BID	Tolterodine n=23 Participants Tolterodine: 2 mg daily	Tolterodine + Terazosin n=24 Participants Tolterodine + Terazosin: 2mg daily and 2mg BID
Pain	4.16 units on a scale Standard Deviation 3.59	3.21 units on a scale Standard Deviation 4.14	1.34 units on a scale Standard Deviation 2.60	1.37 units on a scale Standard Deviation 2.56

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Terazosin

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Tolterodine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Tolterodine + Terazosin

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=24 participants at risk Placebo: same as tolterodine and terazosin dose	Terazosin n=23 participants at risk Terazosin: 2 mg BID	Tolterodine n=23 participants at risk Tolterodine: 2 mg daily	Tolterodine + Terazosin n=24 participants at risk Tolterodine + Terazosin: 2mg daily and 2mg BID
Vascular disorders Orthostatic hypotension	8.3% 2/24 • Number of events 2	17.4% 4/23 • Number of events 4	4.3% 1/23 • Number of events 1	25.0% 6/24 • Number of events 6

Other adverse events

Adverse event data not reported

Additional Information

Yousef Rezaei

Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences

Phone: +989126231864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place