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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)
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author
organization
publishing date
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
2014-02-10 12:16:04
date last changed
2017-11-12 03:34:05
@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&lt;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},
  keyword      = {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},
  volume       = {121},
  year         = {2014},
}