Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial
Rudnicki, M. ; Laurikainen, E. ; Pogosean, R. ; Kinne, I. ; Jakobsson, Ulf LU
and Teleman, Pia
LU
(2014)
In BJOG: An International Journal of Obstetrics & Gynaecology
121(1).
p.102-110
- Abstract
- ObjectiveTo investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy. DesignA randomised controlled study. SettingSix departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark. PopulationWomen aged 55years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage2 or higher. MethodsWomen scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms,... (More)
- ObjectiveTo investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy. DesignA randomised controlled study. SettingSix departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark. PopulationWomen aged 55years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage2 or higher. MethodsWomen scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire. Main outcome measuresThe primary outcome was objective cure, defined as prolapse below POP-Q stage2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications. ResultsIn total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.96.4years versus 64.7 +/- 6.6years, respectively; mean +/- SD). The objective cure rate was 39.8% (95%CI 28.6-50.9%) in the anterior colporrhaphy group, compared with 88.1% (95%CI 80.7-95.6%) in the mesh group (P<0.001). Vaginal mesh exposure occurred in ten women (13.3%) and dyspareunia occurred in two women (2.7%, not significant) in the mesh group at the 12-months follow-up. Questionnaires revealed no difference between the groups. ConclusionsOur study demonstrates a significantly improved objective cure rate associated with a high exposure rate among women with mesh surgery as opposed to conventional surgery. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4261853
- author
- Rudnicki, M.
; Laurikainen, E.
; Pogosean, R.
; Kinne, I.
; Jakobsson, Ulf
LU
and Teleman, Pia
LU
- organization
- publishing date
- 2014
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Anterior repair, collagen coated, mesh, pelvic organ prolapse, randomised controlled trial
- in
- BJOG: An International Journal of Obstetrics & Gynaecology
- volume
- 121
- issue
- 1
- pages
- 102 - 110
- publisher
- Wiley-Blackwell
- external identifiers
-
- wos:000328647800014
- scopus:84890983145
- ISSN
- 1471-0528
- DOI
- 10.1111/1471-0528.12454
- language
- English
- LU publication?
- yes
- id
- 7f987d61-e907-42df-8f58-e4d5635bce9f (old id 4261853)
- date added to LUP
- 2016-04-01 12:58:59
- date last changed
- 2022-01-27 08:40:25
@article{7f987d61-e907-42df-8f58-e4d5635bce9f,
abstract = {{ObjectiveTo investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy. DesignA randomised controlled study. SettingSix departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark. PopulationWomen aged 55years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage2 or higher. MethodsWomen scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire. Main outcome measuresThe primary outcome was objective cure, defined as prolapse below POP-Q stage2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications. ResultsIn total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.96.4years versus 64.7 +/- 6.6years, respectively; mean +/- SD). The objective cure rate was 39.8% (95%CI 28.6-50.9%) in the anterior colporrhaphy group, compared with 88.1% (95%CI 80.7-95.6%) in the mesh group (P<0.001). Vaginal mesh exposure occurred in ten women (13.3%) and dyspareunia occurred in two women (2.7%, not significant) in the mesh group at the 12-months follow-up. Questionnaires revealed no difference between the groups. ConclusionsOur study demonstrates a significantly improved objective cure rate associated with a high exposure rate among women with mesh surgery as opposed to conventional surgery.}},
author = {{Rudnicki, M. and Laurikainen, E. and Pogosean, R. and Kinne, I. and Jakobsson, Ulf and Teleman, Pia}},
issn = {{1471-0528}},
keywords = {{Anterior repair; collagen coated; mesh; pelvic organ prolapse; randomised controlled trial}},
language = {{eng}},
number = {{1}},
pages = {{102--110}},
publisher = {{Wiley-Blackwell}},
series = {{BJOG: An International Journal of Obstetrics & Gynaecology}},
title = {{Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial}},
url = {{http://dx.doi.org/10.1111/1471-0528.12454}},
doi = {{10.1111/1471-0528.12454}},
volume = {{121}},
year = {{2014}},
}