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

NCT ID: NCT06803030

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-30

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ureteral Stent-Related Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tamsulosin group

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

Group Type ACTIVE_COMPARATOR

Tamsulosin Hydrochloride 0.4 mg

Intervention Type DRUG

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

Solifenacin group

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

Group Type ACTIVE_COMPARATOR

Solifenacin Succinate 5 mg

Intervention Type DRUG

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

Mirabegron group

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

Group Type ACTIVE_COMPARATOR

Mirabegron 25 mg

Intervention Type DRUG

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

Interventions

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Tamsulosin Hydrochloride 0.4 mg

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

Intervention Type DRUG

Solifenacin Succinate 5 mg

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

Intervention Type DRUG

Mirabegron 25 mg

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

Intervention Type DRUG

Other Intervention Names

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Cap. Urimax 0.4 mg Tab. Solay 5 mg Tab. Mirasin 25 mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nepal Health Research Council

OTHER_GOV

Sponsor Role collaborator

Bir Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jainendra Kumar Manoj

M Ch Urology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NAMS, Bir Hospital

Kathmandu, Bagmati, Nepal

Site Status RECRUITING

Countries

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Nepal

Central Contacts

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Baikuntha Adhikari, MCh

Role: CONTACT

+977 9849896780

Facility Contacts

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Jainendra K Manoj, Dr

Role: primary

9841529629

Other Identifiers

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BirH

Identifier Type: -

Identifier Source: org_study_id

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