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Meta-Analysis
. 2019 Dec 10;12(12):CD002239.
doi: 10.1002/14651858.CD002239.pub4.

Laparoscopic colposuspension for urinary incontinence in women

Affiliations
Meta-Analysis

Laparoscopic colposuspension for urinary incontinence in women

Jawad Freites et al. Cochrane Database Syst Rev. .

Abstract

Background: Laparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities. This Cochrane Review was last updated in 2010.

Objectives: To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions.

Search methods: We searched the Cochrane Incontinence Specialised Register (22 May 2019), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings.

Selection criteria: Randomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm.

Data collection and analysis: We independently extracted data from eligible trials, assessed risk of bias and implemented GRADE.

Main results: We included 26 trials involving 2271 women. Thirteen trials (1304 women) compared laparoscopic colposuspension to open colposuspension and nine trials (412 women) to midurethral sling procedures. One trial (161 women) compared laparoscopic colposuspension with one suture to laparoscopic colposuspension with two sutures; and three trials (261 women) compared laparoscopic colposuspension with sutures to laparoscopic colposuspension with mesh and staples. The majority of trials did not follow up participants beyond 18 months. Overall, there was unclear risk of selection, performance and detection bias and generally low risk of attrition and reporting bias. There is little difference between laparoscopic colposuspension using sutures and open colposuspension for subjective cure within 18 months (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.99 to 1.08; 6 trials, 755 women; high-quality evidence). We are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low-quality evidence) or whether there is a greater risk of repeat continence surgery with laparoscopic colposuspension. Laparoscopic colposuspension may have a lower risk of perioperative complications (RR 0.67, 95% CI 0.47 to 0.94; 11 trials, 1369 women; low-quality evidence). There may be similar or higher rates of bladder perforations with laparoscopic colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 10 trials, 1311 women; moderate-quality evidence). Rates for de novo detrusor overactivity (RR 1.29, 95% CI 0.72 to 2.30; 5 trials, 472 women) and voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 5 trials, 507 women) may be similar but we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. There may be little difference between laparoscopic colposuspension using sutures and tension-free vaginal tape (TVT) for subjective cure within 18 months (RR 1.01, 95% CI 0.88 to 1.16; 4 trials, 256 women; low-quality evidence) or between laparoscopic colposuspension using mesh and staples and TVT (RR 0.71, 95% CI 0.55 to 0.91; 1 trial, 121 women; low-quality evidence). For laparoscopic colposuspension compared with midurethral slings, there may be lower rates of repeat continence surgery (RR 0.40, 95% CI 0.04 to 3.62; 1 trial, 70 women; low-quality evidence) and similar risk of perioperative complications (RR 0.99, 95% CI 0.60 to 1.64; 7 trials, 514 women; low-quality evidence) but we are uncertain due to the wide confidence intervals. There may be little difference in terms of de novo detrusor overactivity (RR 0.80, 95% CI 0.34 to 1.88; 4 trials, 326 women; low-quality evidence); and probably little difference in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 5 trials, 412 women; moderate-quality evidence) although we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. No studies reported on bladder perforations. Low-quality evidence indicates that there may be higher subjective cure rates within 18 months with two sutures compared to one suture (RR 1.37, 95% CI 1.14 to 1.64; 1 trial, 158 women). Comparing one suture and two sutures, one suture may have lower rates of repeat continence surgery (RR 0.35, 95% CI 0.01 to 8.37; 1 trial, 157 women) and similar risk of perioperative complications (RR 0.88, 95% CI 0.45 to 1.70) but we are uncertain due to the wide 95% CIs. There may be higher rates of voiding dysfunction with one suture compared to two sutures (RR 2.82; 95% CI 0.30 to 26.54; 1 trial, 158 women; low-quality evidence), but we are uncertain due to the wide confidence interval. This trial did not report bladder perforations, de novo detrusor overactivity or quality of life. We are uncertain whether laparoscopic colposuspension with sutures is better or worse for subjective cure within 18 months compared to mesh and staples (RR 1.24, 95% CI 0.96 to 1.59; 2 trials, 180 women; very low-quality evidence) or in terms of repeat continence surgery (RR 0.97, 95% CI 0.06 to 14.91; 1 trial, 69 women; very low-quality evidence). Laparoscopic colposuspension with sutures may increase the number of perioperative complications compared to mesh and staples (RR 1.94, 95% CI 1.09 to 3.48; 3 trials, 260 women; low-quality evidence) but rates of de novo detrusor overactivity may be similar (RR 0.72, 95% CI 0.17 to 3.06; 2 trials, 122 women; low-quality evidence), however, we are uncertain due to the wide confidence interval. None of the studies reported bladder perforations, voiding dysfunction or quality of life.

Authors' conclusions: The data indicate that, in terms of subjective cure of incontinence within 18 months, there is probably little difference between laparoscopic colposuspension and open colposuspension, or between laparoscopic colposuspension and midurethral sling procedures. Much of the evidence is low quality, meaning that a considerable degree of uncertainty remains about laparoscopic colposuspension. Future trials should recruit adequate numbers, conduct long-term follow-up and measure clinically important outcomes. A brief economic commentary identified three studies. We have not quality-assessed them and they should be interpreted in light of the findings on clinical effectiveness.

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Conflict of interest statement

JF: none known FS: none known MIO: none known AM: none known WA: Wael Agur has received a Research Fellowship from the Chief Scientist Office, NHS Research Scotland and support for travel to meetings from the University of Aberdeen; trainer and speaker fees from CR Bard for training surgeons on mesh procedures for incontinence and prolapse, sponsorship from Boston Scientific for training on mesh procedures for prolapse, sponsorship from Neomedic for training on mesh procedures for incontinence, trainer and speaker fees from SEP Pharma/Contura, NHS Ayrshire & Arran, and the London Medical Education Academy for cadaver training on native tissue continence surgery, including laparoscopic colposuspension; consultancy fees from Astellas and SEP Pharma/Contura; expert fees from the Central Legal Office of NHS Scotland and various law firms in Scotland, England, USA, the Republic of Ireland and Australia for provision of medicolegal advice, expert report writing and/or appearance in court, on mesh litigation; and institutional research support as principal investigator for the SIMS pilot studies, PROSPECT, VUE, POPPY, OPAL, TOPSY and PURSUIT studies.

Figures

1
1
PRISMA study flow diagram: search for effectiveness studies
2
2
PRISMA study flow diagram: search for economic evaluations for the BEC
3
3
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies
4
4
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
1.1
1.1. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 1 Subjective cure within 18 months.
1.2
1.2. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 2 Subjective cure from 18 months up to 5 years.
1.3
1.3. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 3 Objective cure within 18 months.
1.4
1.4. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 4 Objective cure from 18 months up to 5 years.
1.5
1.5. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 5 Objective cure after 5 years.
1.6
1.6. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 6 Length of inpatient stay (days).
1.7
1.7. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 7 Time to return to daily activities (days).
1.8
1.8. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 8 Operation time (minutes).
1.9
1.9. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 9 Blood loss (mL).
1.10
1.10. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 10 Duration of catheterisation (days).
1.11
1.11. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 11 Perioperative complications (number of events).
1.12
1.12. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 12 Bladder perforations.
1.13
1.13. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 13 De novo detrusor overactivity (urodynamic diagnosis).
1.14
1.14. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 14 Voiding dysfunction within 18 months.
1.15
1.15. Analysis
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 15 Quality of life.
2.1
2.1. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 1 Subjective cure within 18 months.
2.2
2.2. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 2 Number of women with de novo urgency symptoms.
2.3
2.3. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 3 Incontinence episodes per week.
2.4
2.4. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 4 Objective cure within 18 months.
2.5
2.5. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 5 Length of inpatient stay (days).
2.6
2.6. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 6 Time to return to daily activities (days).
2.7
2.7. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 7 Operation time (mins).
2.8
2.8. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 8 Perioperative complications (number of events).
2.9
2.9. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 9 De novo detrusor overactivity (urodynamic diagnosis) within 18 months.
2.10
2.10. Analysis
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 10 Voiding dysfunction within 18 months.
3.1
3.1. Analysis
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 1 Subjective cure within 18 months.
3.2
3.2. Analysis
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 2 Objective cure within 18 months.
3.3
3.3. Analysis
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 3 Perioperative complications.
3.4
3.4. Analysis
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 4 De novo detrusor overactivity within 18 months.

Update of

References

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Kitchener 2006 {published data only}
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References to studies excluded from this review

Choi 2006 {published data only}
    1. Choi SJ, Kim YH, Choi SH, Ki WS, Kim SA, Jung H. A prospective study of transobturator tension free tape (TOT) and laparoscopic Burch operation for stress urinary incontinence (Abstract number 462). International Urogynecology Journal 2006;17(Suppl 2):307. [sr‐incont64442]
Foote 2007 {published data only}
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ISRCTN44339585 {published data only}
    1. ISRCTN44339585. Laparoscopic treatment for female urinary incontinence. isrctn.org/ISRCTN44339585 (first received 23 January 2004). [ISRCTN44339585; sr‐incont17206]
Koster 1996 {published data only}
    1. Koster S, Volz J, Melchert F. Indications for 3 D laparoscopy in gynecology [Zur indikation der 3 D‐laparoskopie in der gynaekologie]. Geburtshilfe und Frauenheilkunde 1996;56(8):431‐3. [sr‐incont6892] - PubMed
Lee 1997 {published data only}
    1. Lee YS, Kim JH, Seo JT. A comparison of laparoscopic versus open Burch procedure for stress urinary incontinence. International Urogynecology Journal of Pelvic Floor Dysfunction 1997;8(1 Suppl):S37. [sr‐incont9822]
Lernis 1997 {published data only}
    1. Lernis P, Pantekhis G, Kalakoutis G. Presentation of our experience with laparoscopic colposuspension (Burch) at Makarios Hospital, Nicosia, Cyprus. Acta Obstetricia et Gynecologica Scandinavica 1997;76 Suppl 167(1):14. [sr‐incont6669]
NCT00573703 {published data only}
    1. NCT00573703, Palomba S, Zullo F. Laparoscopic Burch colposuspension versus transobturatory tape for the treatment of female urinary stress incontinence [A comparison between laparoscopic Burch colposuspension and transobturatory tape (TOT) for the treatment of female urinary stress incontinence]. clinicaltrials.gov/show/NCT00573703 (first received 14 December 2007). [NCT00573703; sr‐incont61582]
Prezioso 2013 {published data only}
    1. Prezioso D, Iacono F, Lauro G, Illiano E, Romeo G, Ruffo A, et al. Retraction note: stress urinary incontinence: long‐term results of laparoscopic Burch colposuspension. BMC Surgery 2016;16(1):26 [Retraction of: BMC Surgery 2013;13(Suppl 2):S38. doi: 10.1186/1471‐2482‐13‐S2‐S38. PMC3851039]. [PMC4848875; PUBMED: 27122153] - PMC - PubMed
    1. Prezioso D, Iacono F, Lauro G, Illiano E, Romeo G, Ruffo A, et al. Stress urinary incontinence: long‐term results of laparoscopic Burch colposuspension. BMC Surgery 2013;13(Suppl 2):38 [Retraction in: BMC Surgery 2016;16(1):26. doi: 10.1186/s12893‐016‐0141‐6. PMC4848875]. [sr‐incont49424; PUBMED: 24268031] - PMC - PubMed
Salam 2004 {published data only}
    1. Salam TA. Laproscopic versus conventional surgical treatment of genuine urinary stress incontinence (Abstract number 4). Progres en Urologie 2004;14(3 Suppl 3):6. [sr‐incont31091]

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References to other published versions of this review

Dean 2006
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Moehrer 2000
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Publication types