Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries
A legfontosabb adatok
- Hol
- College Station és Galveston (Egyesült Államok)Mind a 2 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Texas A&M UniversityCollege Station, Egyesült ÁllamokNo longer taking part
- University of Texas Medical BranchGalveston, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- The University of Texas Medical Branch, Galveston
- Azonosító
- NCT04565925
- A regiszteradat frissítve
- 2026. szeptember 9.
- Eredeti leírás
The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.A teljes eredeti leírásKevesebb
The goal of this study is to determine whether administration of sildenafil will decrease urine leakage in patients with spinal cord injuries.
Bevonási feltételek: 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.
Kizáró feltételek: 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; 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; History of greater than 4 urinary tract infections per year; Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease; Active cancer; HIV, Hepatitis B, or Hepatitis C; Known allergic reaction to any agent under investigation or required by the protocol; Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation; In phone prescreen, delighted or pleased with current quality of life due to urinary symptoms; Indwelling catheter; Multiple sclerosis; 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); Use of alpha blockers, anticholinergic agents, bethanechol, or other UI treatment within the past 2 weeks ( 3 weeks for long acting muscarinic receptor antagonists); Females who are pregnant or lactating.