NCT02345980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_4 quality-of-life

Timeline
Completed

Started Mar 2014

Typical duration for phase_4 quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

October 1, 2014

Last Update Submit

June 27, 2017

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Ureteral Stent Symptoms Questionnaire (USSQ) Score

    Comparison of total USSQ scores between study arms.

    2-4 weeks

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events

    2-4 weeks

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR

Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Patient in this arm will receive placebo daily after ureteral stent fixation.

Drug: Placebo

Interventions

SildenafilDRUG
Also known as: Viagra
Sildenafil
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patient aged \>18 years

You may not qualify if:

  • Patients who had LUTS before DJ stent fixation
  • DJ stent fixation after open surgery
  • Contraindication to Sildenafil citrate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

  • Tharwat M, Elsaadany MM, Lashin AM, El-Nahas AR. A randomized controlled trial evaluating sildenafil citrate in relieving ureteral stent-related symptoms. World J Urol. 2018 Nov;36(11):1877-1881. doi: 10.1007/s00345-018-2339-y. Epub 2018 May 15.

    PMID: 29766318DERIVED

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed R EL-Nahas, MD

    Urology and Nephrology Center, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology & Nephrology Center

Study Record Dates

First Submitted

October 1, 2014

First Posted

January 26, 2015

Study Start

March 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

EG(1)