A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms

Phase 4

Completed

• Conditions: Quality of Life
• Interventions: Drug: Placebo; Drug: Sildenafil

• Registration Number: NCT02345980
• Lead Sponsor: Mansoura University

Brief Summary

Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%.

This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.

Detailed Description

Adult patient (\>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.

Exclusion criteria:

1. Patients who had lower urinary tract symptoms before stent fixation.

2. Ureteral stent fixation after open surgery.

3. Known contraindications to Sildenafil Citrate

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 94

Inclusion Criteria

1. Patient aged >18 years

Exclusion Criteria

1. Patients who had LUTS before DJ stent fixation
2. DJ stent fixation after open surgery
3. Contraindication to Sildenafil citrate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patient in this arm will receive placebo daily after ureteral stent fixation.
Sildenafil	Sildenafil	Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.

Primary Outcome Measures

Name	Time	Method
Ureteral Stent Symptoms Questionnaire (USSQ) Score	2-4 weeks	Comparison of total USSQ scores between study arms.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	2-4 weeks	Analyzing frequency and severity of side effects of Sildenafil

Trial Locations

Locations (1)

Urology and Nephrology Center, Mansoura University; 🇪🇬 Mansoura, Egypt