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

June 27, 2017 updated by: Ahmed R. EL-Nahas, Mansoura University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Urology and Nephrology center, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sildenafil
Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.
Drug: Sildenafil
Other Names:
  • Viagra
Placebo Comparator: Placebo
Patient in this arm will receive placebo daily after ureteral stent fixation.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ureteral Stent Symptoms Questionnaire (USSQ) Score
Time Frame: 2-4 weeks
Comparison of total USSQ scores between study arms.
2-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 2-4 weeks
Analyzing frequency and severity of side effects of Sildenafil
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmed R EL-Nahas, MD, Urology and Nephrology Center, Mansoura University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sildenafil and USS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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