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Completed

NCT Number: NCT07114848

Comparing Tamsulosin and Solifenacin for Relieving Double J Stent Symptoms: Using the USSQ.

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).

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liaquat National Hospital, Karachi, Pakistan

Karachi, Sindh, 75330, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tamsulosin

Drug

Tamsulosin 0.4 mg once daily for 14 days

Other names: Tamsolin

solifenacin

Drug

Solifenacin 5 mg once daily for 14 day

Other names: solifen

Primary outcomes

  1. Change in total USSQ score

    Time frame: 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 outcomes

  1. Urinary index score

    Time frame: 14days

  2. Pain index score

    Time frame: 14days

  3. General Health Index score

    Time frame: 14days

  4. Work Performance Index Score

    Time frame: 14days

  5. Sexual Function Index Score

    Time frame: 14days

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Official study title

Comparative Efficacy of Tamsulosin and Solifenacin in Managing Double J Stent-Related Symptoms: A Randomized Clinical Study Using the USSQ Tool.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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