Urinary Incontinence, Stress Clinical Trial
Official title:
A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.
Urinary incontinence is the involuntary loss of urine and can affect both men and women
throughout their lives. Women are more likely to develop incontinence as a result of
pregnancy and childbirth. There are approximately 11 million cases of incontinence in the US
contributing to several different types of incontinence including :
- Urge - 30% of the market
- Stress - 30% of the market of which 85% are women
- Combination urge and stress - 40%
Despite advances in behavioral therapy, pharmacological advances as well as development of
minimally invasive surgical procedures, only one out of every twelve people affected
actually seek help.
Prolapse
Globally, approximately 1 million women suffer uterovaginal prolapse annually and this
condition can be associated with urinary incontinence. The breakdown of treatments for
uterovaginal prolapse includes:
- 20% - no treatment
- 20% - non surgical management (pessary)
- 60% - receive a surgical procedure of a suture repair or mesh repair
There were greater than 600,000 surgeries performed globally to treat prolapse. These
numbers are projected to increase due to rapid, easy, and less costly methods as well as new
products that facilitate the easier procedures.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02001714 -
Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
|
N/A | |
| Not yet recruiting |
NCT00523068 -
Pharmacological vs Surgical Treatment for Mixed Incontinence
|
Phase 4 | |
| Completed |
NCT00904969 -
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
|
N/A | |
| Completed |
NCT00190814 -
Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.
|
Phase 3 | |
| Completed |
NCT00190827 -
Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)
|
Phase 3 | |
| Terminated |
NCT00247286 -
Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.
|
Phase 4 | |
| Completed |
NCT01959347 -
Combined Treatment for Mixed Incontinence
|
Phase 3 | |
| Completed |
NCT00244296 -
To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms
|
Phase 4 | |
| Not yet recruiting |
NCT05570071 -
A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.
|
N/A | |
| Completed |
NCT02334878 -
Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence
|
Phase 3 | |
| Completed |
NCT01382602 -
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
|
Phase 3 | |
| Completed |
NCT03296462 -
Hip External Rotation Physical Therapy Trial
|
N/A | |
| Recruiting |
NCT02750878 -
Surgical Consent Process for Trans-obturator Tape Slings.
|
N/A | |
| Completed |
NCT02296099 -
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
|
Phase 4 | |
| Completed |
NCT02599051 -
Transobturator Verus Single Incision Slings
|
N/A | |
| Completed |
NCT00138749 -
An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
|
Phase 2 | |
| Terminated |
NCT03614611 -
Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence
|
N/A | |
| Completed |
NCT03722719 -
The Knack on Female Stress Urinary Incontinence
|
N/A | |
| Active, not recruiting |
NCT02275728 -
Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence
|
N/A | |
| Terminated |
NCT01358214 -
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
|
N/A |