Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms

NCT ID: NCT06966804

Last Updated: 2025-09-05

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-05-31

Brief Summary

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The goal of this clinical trial is to compare how well Terazosin, Tamsulosin and standard care (no alpha-blocker) reduce urinary symptoms after ureteral stent placement. This trial also learn about the safety of these two study medications.

Main objective:

• To compare how well Terazosin, Tamsulosin and standard of care reduce post-stenting urinary symptoms.

Secondary objectives:

* To compare painkiller use among the groups.
* To assess differences in Body pain, General health, Work performance, Sexual matters, and Additional problems using a questionnaire (USSQ).
* To assess differences in side effects.

After stent placement, subjects will be randomly assigned to one of three groups:

1. Terazosin (alpha-blocker) for 14 days
2. Tamsulosin (alpha-blocker) for 14 days
3. Standard of care (no alpha-blocker). All subjects will be discharged with standard pain-killers and a diary to track usage. Subjects in Terazosin and Tamsulosin groups will receive respective study medications to complete 14 days course of treatment.

Follow-Up:

* Day 7: A phone call will check medication use and any side effects.
* Day 15: Clinic visit for stent removal (standard practice). Subjects will complete the USSQ questionnaire, and medication compliance will be reviewed.

End of study: Final phone call to check for any additional side effects.

Detailed Description

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Conditions

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Stent Related Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Terazosin

Terazosin 2mg ON

Group Type EXPERIMENTAL

Terazosin

Intervention Type DRUG

Subject will complete 14-day course of Terazosin

Tamsulosin

Tamsulosin 0.4mg ON

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Subject will complete 14-day course of Tamsulosin

Standard care

No medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Terazosin

Subject will complete 14-day course of Terazosin

Intervention Type DRUG

Tamsulosin

Subject will complete 14-day course of Tamsulosin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Malaysian age 18 years old and above.
2. Able to provide written informed consent to participate in the trial.
3. Willing to comply with study procedures.
4. Unilateral intracorporeal lithotripsy procedure with ureteral stent placement for uncomplicated ureteric or renal calculi

Exclusion Criteria

1. Known comorbidity that increase the risk of complication

1. Prostate pathology: Benign prostate hyperplasia, prostatitis, prostatic carcinoma
2. Bladder pathology: Bladder tumor, stone, overactive bladder
3. Ureteral abnormality/ trauma, urethral stricture
4. Concomitant urinary tract infection
5. Orthostatic hypotension
6. Solitary kidney
2. Previous pelvic/ gynaecological surgery
3. Patient is concomitantly receiving treatment from a pain clinic for chronic pain management.
4. Pregnancy (for women of childbearing potential)
5. Known history of allergic reactions to tamsulosin or terazosin
6. Patient is concomitantly taking warfarin or H2 receptor blockers
7. Patients with clinical condition(s) judged by the researcher/ clinician to be unsuitable for participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penang Hospital, Malaysia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ooi Yeon Wee

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sultanah Bahiyah Hospital, Alor Setar

Alor Star, Kedah, Malaysia

Site Status RECRUITING

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Yeon Wee Ooi

Role: CONTACT

6042225333

Facility Contacts

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Yeon Wee Ooi, Medical Degree

Role: primary

04-740 6233

Yeon Wee Ooi, Medical Degree

Role: primary

6042225333

Other Identifiers

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RSCH ID-24-05599-H07

Identifier Type: OTHER

Identifier Source: secondary_id

NMRR-24-03594-URB

Identifier Type: -

Identifier Source: org_study_id

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