RECRUITING

Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries

Conditions

Spinal Cord Injuries Urinary Incontinence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.

Official Title

Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries

Quick Facts

Study Start:2021-07-07

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04565925

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults with spinal cord injury (SCI), 18-75 years of age, at the time of consent * Have urinary incontinence (UI), with at least 3 leakage episodes/week * Have urodynamics assessment on file with their provider in past 3 years. If no historical data on file, subject may complete prior to study visit 1. * Willing and able to comply with study procedures * Willing and able to provide written informed consent	* In phone prescreen, delighted or pleased with current quality of life due to urinary symptoms. * Indwelling catheter * History of greater than 4 urinary tract infections per year * Multiple sclerosis * Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease * Systolic blood pressure \<90 or \>170, diastolic blood pressure \<50 or \>110 after repeated evaluation with proper cuff. This range is the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110) * Active cancer * HIV, Hepatitis B, or Hepatitis C * Use of systemic nitrates, anabolic steroids, corticosteroids, or long acting PDE5 inhibitors in the past 1 month * Use of short acting PDE5 inhibitors in the past 1 week * Use of alpha blockers, anticholinergic agents, bethanechol, or other UI treatment within the past 2 weeks ( 3 weeks for long acting muscarinic receptor antagonists) * Known allergic reaction to any agent under investigation or required by the protocol * Females who are pregnant or lactating * Atonic bladder or high detrusor and high pelvic floor muscle pressure based on previous cystometrogram (CMG) (on file with their provider) that would place subjects at risk for kidney injury * Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation

Inclusion Criteria

Exclusion Criteria

* Adults with spinal cord injury (SCI), 18-75 years of age, at the time of consent
* Have urinary incontinence (UI), with at least 3 leakage episodes/week
* Have urodynamics assessment on file with their provider in past 3 years. If no historical data on file, subject may complete prior to study visit 1.
* Willing and able to comply with study procedures
* Willing and able to provide written informed consent

* In phone prescreen, delighted or pleased with current quality of life due to urinary symptoms.
* Indwelling catheter
* History of greater than 4 urinary tract infections per year
* Multiple sclerosis
* Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease
* Systolic blood pressure \<90 or \>170, diastolic blood pressure \<50 or \>110 after repeated evaluation with proper cuff. This range is the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110)
* Active cancer
* HIV, Hepatitis B, or Hepatitis C
* Use of systemic nitrates, anabolic steroids, corticosteroids, or long acting PDE5 inhibitors in the past 1 month
* Use of short acting PDE5 inhibitors in the past 1 week
* Use of alpha blockers, anticholinergic agents, bethanechol, or other UI treatment within the past 2 weeks ( 3 weeks for long acting muscarinic receptor antagonists)
* Known allergic reaction to any agent under investigation or required by the protocol
* Females who are pregnant or lactating
* Atonic bladder or high detrusor and high pelvic floor muscle pressure based on previous cystometrogram (CMG) (on file with their provider) that would place subjects at risk for kidney injury
* Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation

Contacts and Locations

Study Contact

Kate M Randolph, BS

CONTACT

409-223-7891

kmrandol@utmb.edu

Kathy Vincent, MD

CONTACT

409-772-2610

klvincen@utmb.edu

Principal Investigator

Kathy Vincent, MD

PRINCIPAL_INVESTIGATOR

University of Texas

Study Locations (Sites)

Texas A&M University

College Station, Texas, 77843

United States

University of Texas Medical Branch

Galveston, Texas, 77555

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Kathy Vincent, MD, PRINCIPAL_INVESTIGATOR, University of Texas

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 Registration Dates

Study Start Date2021-07-07

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-07-07

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Spinal Cord Injuries
Urinary Incontinence