Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Evaluation of Ureteral Stent Symptoms
Overview
Brief Summary
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.
Detailed Description
Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.
The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.
Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .
Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.
Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 71 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •\- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.
Exclusion Criteria
- •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.
- •Patients with neurological conditions were excluded.
- •Patients with a history of pelvic radiation were excluded.
- •Patients with diabetes were excluded.
- •Patients with kidney dysfunction (acute or chronic) were excluded.
- •Patients with a solitary kidney were excluded.
- •Patients with congenital urinary anomalies were excluded.
Arms & Interventions
Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms
Intervention: Tamsulosin (Drug)
Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms
Intervention: Tamsulosin (Drug)
Outcomes
Primary Outcomes
Evaluation of Ureteral Stent Symptoms
Time Frame: 4 weeks
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Amr
Resident at Urology Department
Ain Shams University