Pelvic Organ Prolapse, Urinary Incontinence
Conditions
Keywords
Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery
Brief summary
To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair
Detailed description
Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.
Interventions
PROCEDUREPelvic organ prolapse repair and Burch colposuspension
Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Study inclusion criteria were POP \> 2, UI as was defined by ICS \[2\], age ≥ 18 and ≤ 75 yrs.
Exclusion criteria
* 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 * Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test. | 2002-2006 |
Secondary
| Measure | Time frame |
|---|---|
| changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires | 2002-2206 |
Countries
Italy
Outcome results
None listed