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

Bir Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Ureteral Stent-Related Symptom

Treatments: Drug: Solifenacin Succinate 5 mg; Drug: Tamsulosin Hydrochloride 0.4 mg; Drug: Mirabegron 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06803030

BirH

Details and patient eligibility

About

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

Full description

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.

Enrollment: 189 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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189 participants in 3 patient groups

Tamsulosin group

Active Comparator group

Description:

placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom

Treatment:

Drug: Tamsulosin Hydrochloride 0.4 mg

Solifenacin group

Active Comparator group

Description:

placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom

Treatment:

Drug: Solifenacin Succinate 5 mg

Mirabegron group

Active Comparator group

Description:

placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom

Treatment:

Drug: Mirabegron 25 mg