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NCT Number: NCT06803030

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NAMS, Bir Hospital

Kathmandu, Bagmati, 44600, Nepal

Location status: Recruiting

Location contact

Jainendra K Manoj, Dr

CONTACT

[email protected]

9841529629

About this study

Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones

Exclusion criteria

  • Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
  • Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
  • Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
  • Preoperative febrile Urinary Tract Infection (UTI)
  • Pregnancy or breastfeeding;
  • A single kidney
  • Moderate or severe cardiovascular or cerebrovascular disease
  • Hepatic dysfunction
  • History of pelvic surgery or irradiation
  • History of bladder or prostate surgery
  • Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score
  • Allergy to any medication

Treatment and study plan

Tamsulosin Hydrochloride 0.4 MG

Drug

placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily

Other names: Cap. Urimax 0.4 mg

Solifenacin Succinate 5 MG

Drug

placement of ureteral stents followed by Tab. Solifenacin 5 mg once daily

Other names: Tab. Solay 5 mg

Mirabegron 25 MG

Drug

placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily

Other names: Tab. Mirasin 25 mg

Primary outcomes

  1. alleviating Ureteral stent related symptoms

    Time frame: 2 weeks

    mitigating the ureteric stent related symptoms using structured questionnaire

Secondary outcomes

  1. early removal of ureteral stent

    Time frame: before 2 weeks

    early removal of stent due to stent migration, fever, urosepsis

Study contacts

Contact information is provided by the study sponsor or research team.

Baikuntha Adhikari, MCh

CONTACT

[email protected]

+977 9849896780

Sponsors and collaborators

Lead sponsor

Bir Hospital

Other Gov

Collaborators

  • Nepal Health Research Council

Registry information

Official study title

A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Sep 8, 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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