Alpha Blocker, Anticholinergics, Ureteral Stent-Related Symptom, Ureter Calculi
Conditions
Keywords
Tamsulosin vs solifenacin in improving stent related symptoms, Double J stent, Tamsulosin, solifencin, ureteral stent-related symptoms, ussq, alpha-blocker, anticholinergic, RCT, quality of life
Brief summary
This study evaluates the effects of two medications-tamsulosin and solifenacin-on symptoms associated with double J (DJ) ureteral stents. The research is conducted among patients undergoing unilateral DJ stent placement for ureteric calculi or post-ureteroscopic lithotripsy. Participants are randomly assigned to receive either tamsulosin or solifenacin, and symptom severity is assessed using the Ureteral Stent Symptom Questionnaire (USSQ).
Detailed description
Ureteral stents are widely used in urological procedures but are frequently associated with stent-related symptoms such as urinary urgency, pain, and reduced quality of life. These symptoms are believed to arise from mechanical irritation and bladder overactivity. Alpha-blockers and antimuscarinic agents are commonly prescribed to alleviate these effects. This study is designed to compare the effects of tamsulosin, an alpha-1 adrenergic receptor antagonist, and solifenacin, a muscarinic M3 receptor antagonist, in reducing DJ stent-related symptoms. The study is a single-center, randomized clinical trial conducted at the Department of Urology, Liaquat National Hospital, Karachi. Sixty adult patients who undergo unilateral DJ stent placement for ureteric stones or after ureteroscopic lithotripsy are randomized into two equal groups. Group A receives tamsulosin 0.4 mg daily, and Group B receives solifenacin 5 mg daily. Symptom evaluation is performed on day 14 post-procedure using a culturally adapted version of the Ureteral Stent Symptom Questionnaire (USSQ), which assesses domains such as urinary symptoms, pain, general health, work performance, and sexual health. The findings from this study aim to inform treatment decisions for managing stent-related symptoms in similar clinical populations.
Interventions
Tamsulosin 0.4 mg once daily for 14 days
Solifenacin 5 mg once daily for 14 day
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 20 to 50 years * Undergoing unilateral DJ stenting for: * Ureteric calculi * Post-ureteroscopic lithotripsy
Exclusion criteria
* Bilateral stents * History of LUTS or recurrent UTI * Urological malignancy or bladder surgery * Known hypersensitivity to alpha-blockers or anticholinergics * Uncontrolled hypertension, cardiovascular instability * Chronic liver or kidney disease * Stent complications (migration, encrustation, infection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total USSQ score | 14days post stent placement | Total score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health. |
Secondary
| Measure | Time frame |
|---|---|
| Urinary index score | 14days |
| Pain index score | 14days |
| General Health Index score | 14days |
| Work Performance Index Score | 14days |
| Sexual Function Index Score | 14days |
Countries
Pakistan