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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02345980
Enrollment
94
Registered
2015-01-26
Start date
2014-03-31
Completion date
2016-11-30
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

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

Interventions

DRUGSildenafil
DRUGPlacebo

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ureteral Stent Symptoms Questionnaire (USSQ) Score2-4 weeksComparison of total USSQ scores between study arms.

Secondary

MeasureTime frameDescription
Number of participants with treatment-related adverse events2-4 weeksAnalyzing frequency and severity of side effects of Sildenafil

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026