Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-71
SponsorAin Shams University
About this trial
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life.
Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients younger than 18 years of age were excluded.
Patients with a history of prostate or bladder surgery were excluded.
Patients with prior lower urinary tract procedures were excluded.
Patients with cancer were excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
Tamsulosin
DrugEvaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)Active comparator 1 intervention
Group B: Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of Ureteral Stent Symptoms
Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov