Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

Helios Medical Center Schleswig

Status: Unknown

Conditions: Urinary Urge Incontinence

Study type: Observational

Funder types: Other

Identifiers

NCT03640364

HCR051631

Details and patient eligibility

About

Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

Full description

A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence.

Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• urge urinary incontinence or symptoms thereof
• 18 years old or older
• Compliance regarding data collection, therapy and follow-up
• written informed consent
• simultaneous performance of surgical colporrhaphy permitted

Exclusion criteria

• pelvic organ prolapse without symptoms of urinary urge
• age less than 18 years
• no informed consent
• lack of compliance
• adverse reaction to polypropylene
• life expectancy less than anticipated duration of protocol
• ASA 4