Female Stress Urinary Incontinence Clinical Trial
Official title:
Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.
Urinary incontinence (UI), or the complaint of any involuntary loss of urine, ranges in
severity from the occasional leaking urine during actions resulting in increased abdominal
pressure (coughing, sneezing, laughing, exercise, etc.) to sudden, unpredictable strong
urges to void. Female stress urinary incontinence (SUI) is attributed to a weakening of the
pelvic floor muscles.
A recent review of literature describing the prevalence of UI calculated the median
prevalence of female UI to be 27.6% (4.8-58.4%), with the prevalence of significant
incontinence increasing with age. The prevalent cause of UI was further categorized into
stress (50%), mixed (32%) and urge (14%).
Nonsurgical treatment of female SUI has traditionally been limited to alpha-adrenergic
agonists and estrogens, pelvic floor exercises, biofeedback, electrical stimulation and
behavior modification1. Options for surgical treatment consists of periurethral injections
of bulking agents, transvaginal suspensions, retropubic suspensions, slings and sphincter
prostheses.
The Ajust™ Adjustable Single-Incision Sling is a fully adjustable single-incision sling that
anchors in the transobturator membranes, anatomically sufficient spaces for support of the
urethra.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05534269 -
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
|
Phase 2 | |
| Completed |
NCT02023502 -
Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study
|
||
| Completed |
NCT01848938 -
Treatment of Stress Urinary Incontinence Via Smartphone
|
N/A | |
| Completed |
NCT01699425 -
Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
|
N/A | |
| Completed |
NCT02418299 -
Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)
|
N/A | |
| Completed |
NCT01094353 -
A Comparative Study Minisling Versus Transobturator (TOT)Sling
|
Phase 4 | |
| Completed |
NCT00910338 -
Efficacy and Safety of Extracorporeal Biofeedback
|
N/A | |
| Recruiting |
NCT04131387 -
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence
|
N/A | |
| Not yet recruiting |
NCT02981654 -
Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.
|
N/A | |
| Completed |
NCT01032265 -
Web-based Management of Female Stress Urinary Incontinence
|
N/A |