Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence

University Of Perugia

Status: Completed

Conditions: Urinary Incontinence

Study type: Observational

Funder types: Other

Identifiers

NCT00658944

EC_ML_002s

EC_ML_002

Details and patient eligibility

About

To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak point pressure in predicting outcome in patients who underwent trans-obturator tape for the treatment of female stress urinary incontinence.

Full description

A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or > 40 cmH20 and ≤ or > 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

Enrollment: 65 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mixed urinary incontinence (stress component clinically predominant)

Exclusion criteria

• > grade II uro-genital prolapse in any vaginal compartment
• Previous incontinence surgery
• Urine retention, neurogenic bladder, benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
• Active pelvic inflammatory disease
• Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
• Pregnancy or lactation; AND
• Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Trial design

65 participants in 1 patient group

A

Description:

Patients suffering from stress or mixed urinary incontinence