Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg

Ain Shams University

Status: Enrolling

Conditions: Ureteric Stone; Kidney Stone

Treatments: Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT07562282

Ureteric Stent

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)

Active Comparator group

Description:

About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms

Treatment:

Drug: Tamsulosin

Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)

Active Comparator group

Description:

About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms

Treatment:

Drug: Tamsulosin