Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tamsulosin.
- Who it may be relevant to
- Registry conditions: Kidney Stone, Ureteric Stone. Basic parameters: 18 years — 71 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
Overview
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
Interventions
- Drug Tamsulosin
Evaluation 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.
Primary outcome measures
- Evaluation of Ureteral Stent Symptoms [Time frame: 4 weeks]
Eligibility criteria
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.
- Patients taking the following medications were excluded:
- α-blockers
- beta-blockers
- calcium channel blockers
- 5-alpha reductase inhibitors
- PDE5 inhibitors
- anticholinergics
- nitrates
- Patients with cardiac issues were excluded.
- Patients with residual stone fragments after surgery were excluded.
- Patients with multiple or bilateral ureteral stones were excluded.
- Patients with long-term or bilateral stents requiring frequent changes were excluded.
- Patients with interstitial cystitis were excluded.
- Patients with chronic cystitis were excluded.
- Patients with prostatitis were excluded.
- Pregnant women were excluded.
- Breastfeeding women were excluded.
- Patients unavailable for follow-up were excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams University Hospital — Cairo
Identifiers
NCT: NCT07562282 · Ureteric Stent