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NCT02345980 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02345980
Other study ID # Sildenafil and USS
Secondary ID
Status Completed
Phase Phase 4
First received October 1, 2014
Last updated June 27, 2017
Start date March 2014
Est. completion date November 2016

Study information
Verified date June 2017
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 94
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil

• Placebo

Locations
Country Name City State
Egypt Urology and Nephrology Center, Mansoura University Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ureteral Stent Symptoms Questionnaire (USSQ) Score Comparison of total USSQ scores between study arms. 2-4 weeks
Secondary Number of participants with treatment-related adverse events Analyzing frequency and severity of side effects of Sildenafil 2-4 weeks
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