Authors' objectives

To assess the safety and efficacy of tension-free urethropexy for stress urinary incontinence in women.

Searching

MEDLINE, Current Contents, EMBASE and the Cochrane Library (Issue 3, 2000) were searched to June or August 2000. The search strategies were provided in the report. Materials from the International Continence Society Conference (2000) were also checked. The database searches were not restricted by language, but only English language reports were included in the review.

Study selection

Assessment of study quality

The studies were graded as poor, average or good for internal and external validity. The grading for internal validity was based on an assessment of bias, confounding and the role of chance; the grading for external validity was based on the population, inclusion or exclusion criteria and follow-up. Each study was also assigned a level of evidence from I (highest) to IV (lowest). The authors do not state how the papers were assessed for validity, or how many of the reviewers performed the validity assessment.

Data extraction

The data were extracted using standard templates, but the authors do not state how many of the reviewers performed the data extraction. The following data were extracted: the number of women with specific complications and the number of women at risk; the number of women continent or with improved continence and the number initially incontinent. Objective and subjective outcomes were recorded as such.

Methods of synthesis

Results of the review

Fifteen studies (from 17 papers) were included. Two studies examined IVS prototype (n=125), 2 examined two-stage IVS (n=110), and 11 examined TVT (n=662 with some patient data duplication likely between reports).

The included studies provided level IV evidence. Validity was poor or poor/average.

IVS prototype.

No deaths occurred as a consequence of the operation. The complications included infection or erosion and defective healing of the vaginal wall. In one study (n=75) the mean operating time was 30 minutes, the average hospital stay was less than one day, and post-operative voiding resumed within 24 hours. The cure rate (restoration of continence) ranged from 78 to 89%.

Two-stage IVS.

No deaths were reported. The complications included infection and/or erosion, haematometra, infection of the cervix and urinary retention. In one study (n=85) the mean operating time was 25 minutes, the average hospital stay was less than one day, and post-operative bladder catheterisation was required in 6% of the patients. In that study, the cure rate of stress incontinence was 88% and that of urge incontinence 86%. TVT.

No deaths or infection/erosion were reported. There was one case of haemorrhage. The incidence of bladder perforation and of urinary tract infection was 0 to 7%. The incidence of wound infection and of defective vaginal healing was 0 to 2%. Urinary retention ranged from 0 to 3% and post-operative micturition difficulty from 0.8 to 17%. When studies of concurrent gynaecological surgery were excluded, the mean operating time was 22 to 42 minutes and the rate of post-operative bladder catheterisation was 3 to 16%. The estimated mean time to resumption of voiding was 6 to 24 hours (2 studies). One study, which used a visual analogue scale to measure the discomfort caused by incontinence, showed a reduction from 7.5 to 0.5. The mean hospital stay ranged from 8 hours to 3 days, and the cure rate in the first year ranged from 85 to 100%.

The results of studies available only as abstracts, non-English language literature and reviews are also summarised in the report.

Authors' conclusions

The safety and efficacy of tension-free urethropexy, compared with IVS or TVT, cannot be determined because the available evidence is incomplete and of poor quality.

CRD commentary

The review question and the inclusion criteria were clearly defined. The authors point out that their search strategy was pragmatic rather than ideal. The database-specific search strategies used were provided in the report. The study selection process was conducted independently to minimise bias. The possibility of language bias cannot be excluded, as non-English language papers were not included. The critical appraisal of study quality was thorough. Detailed tables of the characteristics of the included studies, and the critical appraisal, were provided. A narrative synthesis was appropriate and the authors' conclusions clearly follow from the evidence presented.

Implications of the review for practice and research

Practice: The authors state that the safety and efficacy of tension-free urethropexy procedures cannot be determined at this time.

Research: The authors state that a RCT should be conducted to assess the safety and efficacy of two-stage IVS, ideally compared with the TVT procedure, along with the Burch colposuspension as the 'gold' standard. They also point out that a RCT of TVT versus Burch colposuspension is currently underway in the UK.

Bibliographic details

Merlin T, Arnold E, Petros P, Tulloch A, MacTaggart P, Jamieson G, Faulkner K, Maddern G. A systematic review of tension-free urethropexy for stress urinary incontinence: intravaginal slingplasty and the tension-free vaginal tape procedures. North Adelaide, S. Australia, Australia: Royal Australasian College of Surgeons, Australian Safety and Efficacy Register of New Interventional Procedures (ASERNIP) - Surgical. ASERNIP-S Report; 11. 2001.

Original Paper URL

http://www.surgeons.org/AM/Template.cfm?Section=ASERNIP_S_Publications&T emplate=/TaggedPage/TaggedPageDisplay.cfm&TPLID=17&ContentID=3297

Other publications of related interest

Merlin T, Arnold E, Petros P, MacTaggart P, Tulloch A, Faulkner K, Maddern G. A systematic review of tension-free urethropexy for stress urinary incontinence: intravaginal slingplasty and the tension-free vaginal tape procedures. BJU Int 2001;88:871-80.

Indexing Status

Subject indexing assigned by CRD

MeSH

Urethra /surgery; Urinary Incontinence, Stress /surgery; Vagina /surgery

AccessionNumber

12002008395

Database entry date

31/07/2003

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.