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Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial.
BJOG. 2006 Sep; 113(9):1007-13.BJOG

Abstract

OBJECTIVE

To compare the effectiveness and cost effectiveness of open and laparoscopic colposuspension in the treatment of stress urinary incontinence.

DESIGN

A randomised controlled trial. Women were randomised between March 1999 and February 2002 and were seen for assessment at 6, 12 and 24 months, postoperatively.

SETTING

Women were recruited from six gynaecology units in the UK.

POPULATION

Women with proven stress urinary incontinence requiring surgery.

METHODS

Open abdominal retropubic colposuspension or laparoscopic colposuspension.

MAIN OUTCOME MEASURES

Primary outcomes were subjective (satisfaction with outcome) and objective (negative 1-hour pad test). Secondary outcomes were operative and postoperative morbidity and quality of life. The study was powered to demonstrate noninferiority, i.e. that the absolute cure rate of laparoscopic colposuspension was no more than 15% below that of open colposuspension.

RESULTS

A total of 291 women were randomised, with 24-month data on subjective and objective outcomes in 88 and 82.5%, respectively. The intention-to-treat analysis indicated no significant difference in cure rates between open and laparoscopic surgery. The objective cure rates for open and laparoscopic were 70.1 and 79.7%, respectively. Subjective cure rates by satisfaction were lower than objective cure; 54.6 and 54.9%, respectively, and there was considerable nonconcordance both ways.

CONCLUSIONS

Laparoscopic colposuspension is not inferior to open colposuspension in terms of curing stress urinary incontinence.

Authors+Show Affiliations

Kitchener HC
Division of Human Development, University of Manchester, Manchester, UK. henry.kitchener@cmmc.nhs.uk
Dunn G
No affiliation info available
Lawton V
No affiliation info available
Reid F
No affiliation info available
Nelson L
No affiliation info available
Smith AR
No affiliation info available
COLPO Study Group
No affiliation info available

MeSH

FemaleHumansIncontinence PadsLaparoscopyLength of StayMiddle AgedTreatment OutcomeUrinary Incontinence, StressVagina

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16956332

Citation

Kitchener, H C., et al. "Laparoscopic Versus Open Colposuspension--results of a Prospective Randomised Controlled Trial." BJOG : an International Journal of Obstetrics and Gynaecology, vol. 113, no. 9, 2006, pp. 1007-13.
Kitchener HC, Dunn G, Lawton V, et al. Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial. BJOG. 2006;113(9):1007-13.
Kitchener, H. C., Dunn, G., Lawton, V., Reid, F., Nelson, L., & Smith, A. R. (2006). Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial. BJOG : an International Journal of Obstetrics and Gynaecology, 113(9), 1007-13.
Kitchener HC, et al. Laparoscopic Versus Open Colposuspension--results of a Prospective Randomised Controlled Trial. BJOG. 2006;113(9):1007-13. PubMed PMID: 16956332.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial. AU - Kitchener,H C, AU - Dunn,G, AU - Lawton,V, AU - Reid,F, AU - Nelson,L, AU - Smith,A R B, AU - ,, PY - 2006/9/8/pubmed PY - 2006/10/25/medline PY - 2006/9/8/entrez SP - 1007 EP - 13 JF - BJOG : an international journal of obstetrics and gynaecology JO - BJOG VL - 113 IS - 9 N2 - OBJECTIVE: To compare the effectiveness and cost effectiveness of open and laparoscopic colposuspension in the treatment of stress urinary incontinence. DESIGN: A randomised controlled trial. Women were randomised between March 1999 and February 2002 and were seen for assessment at 6, 12 and 24 months, postoperatively. SETTING: Women were recruited from six gynaecology units in the UK. POPULATION: Women with proven stress urinary incontinence requiring surgery. METHODS: Open abdominal retropubic colposuspension or laparoscopic colposuspension. MAIN OUTCOME MEASURES: Primary outcomes were subjective (satisfaction with outcome) and objective (negative 1-hour pad test). Secondary outcomes were operative and postoperative morbidity and quality of life. The study was powered to demonstrate noninferiority, i.e. that the absolute cure rate of laparoscopic colposuspension was no more than 15% below that of open colposuspension. RESULTS: A total of 291 women were randomised, with 24-month data on subjective and objective outcomes in 88 and 82.5%, respectively. The intention-to-treat analysis indicated no significant difference in cure rates between open and laparoscopic surgery. The objective cure rates for open and laparoscopic were 70.1 and 79.7%, respectively. Subjective cure rates by satisfaction were lower than objective cure; 54.6 and 54.9%, respectively, and there was considerable nonconcordance both ways. CONCLUSIONS: Laparoscopic colposuspension is not inferior to open colposuspension in terms of curing stress urinary incontinence. SN - 1470-0328 UR - https://www.unboundmedicine.com/medline/citation/16956332/Laparoscopic_versus_open_colposuspension__results_of_a_prospective_randomised_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -