Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Relieve of Ureteral Stent Symptoms

Treatments: Drug: Control; Drug: Tamsulosin; Drug: Solifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01880619

Treatment of USS

Details and patient eligibility

About

This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.

Full description

Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.

Enrollment: 131 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient who will undergo unilateral ureteral stent fixation:

1. To relieve upper urinary tract obstruction caused by ureteric calculi
2. After ureteroscopic lithotripsy for ureteral calculi.

Exclusion criteria

1. Patients who had LUTS before stent fixation.
2. Ureteral stent fixation after open or laparoscopic surgery.
3. Bilateral ureteral stents.
4. Patients who developed complications related to the primary endoscopic procedure
5. Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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131 participants in 3 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

Patients in this group will receive placebo

Treatment:

Drug: Control

Group B

Active Comparator group

Description:

Patients in this group will receive Tamsulosin

Treatment:

Drug: Tamsulosin

Group C

Active Comparator group

Description:

Patients in this group will receive Solifenacin

Treatment:

Drug: Solifenacin