Clinical trial NCT00223106: Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
Official title: A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Mixed Incontinence
Vaginal Vault Prolapse
Keywords: urge incontinence
urinary incontinence
vault prolapse
stess incontinence
mixed incontinence
urine leakage
enterocele
rectocele
cystocele
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 467
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject must be female and \>18 years of age.
* Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.

Exclusion Criteria:

* Any subject with clotting defects, bleeding disorders or receiving anticoagulant treatments AND is determined to be at risk for minimally invasive surgery as determined by the investigator
* Subjects who currently have an untreated urinary tract infection
* Subject is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Subject is pregnant or desires future pregnancies.

Primary outcomes:
measure: Safety and efficacy for incontinence and prolapse procedures.
Secondary outcomes:
measure: Quality of Life Improvement as determined by Questionnaire.
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: US Surgical
state: Connecticut
Study officials:
affiliation: Medtronic - MITG
name: Noreen A. Gannon
role: STUDY_DIRECTOR
References: