Transvaginal mesh implants independent review: interim report
This interim report outlines the work of the Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Chapter 6: The choice of surgical approach of mesh device implantation for the treatment of stress urinary incontinence in women: Clinicians' view
6.1 Clinicians' views
For best outcome of surgery, a well-informed patient is as important as a well-informed clinician. In 2014, the Scottish Government's Expert Group first published a comprehensive leaflet for patients considering surgery using synthetic mesh for stress urinary incontinence (SUI). This leaflet is currently being updated with current evidence and adapted for use by all four UK nations later this year[12].
In 2013, NICE published the document: information to assist counselling of women considering SUI surgery using mesh implants, mainly aimed at clinicians[13]. The document was largely based on the MHRA York report[14]. The following table represents updated level I evidence from the Cochrane Collaboration, building on the NICE and MHRA document, as interpreted by the Scottish Government's Independent Review. Where research evidence is lacking, expert opinion based on collective experience from the expert group of the clinicians is expressed (level III).
Clinicians counselling patients for such surgery may find the updated information useful during the shared-decision process, alongside the national patient information leaflet available on the Scottish Government website and the relevant full NICE guidance.
Table 6.1
| Outcomes from the recent systematic review from the Cochrane Collaboration |
Retropubic mesh tape device |
Transobturator mesh tape device |
RR, 95%CI, number of studies and participants |
Favours... |
Notes on research evidence from the Cochrane Collaboration |
|---|---|---|---|---|---|
| Short term efficacy |
Similar Subjective: 84.4% Objective: 87.2% |
Similar 82.3% 85.7% |
RR 0.98, 95% CI 0.96 to 1.00 36 trials, 5514 women. RR 0.98, 95% CI 0.96 to 1.00 40 trials, 6145 women |
None |
Research evidence favouring retropubic approach for both patient-reported and clinician-reported outcomes did not reach statistical significance. |
| Long term efficacy |
Similar Subjective: 70.7% Objective: 85.5% |
Similar 65.1% 83% |
RR 0.95, 95%CI 0.80 to 1.12. 4 trials, 714 women. RR 0.97, 95% CI 0.90 to 1.06; 3 trials, 400 women |
None |
Research evidence favouring retropubic approach for both patient-reported and clinician-reported outcomes did not reach statistical significance. |
| Need for repeat continence surgery after 1 year |
Lower 1.1% |
Higher 11.3% |
RR 8.79, 95% CI 3.36 to 23.00; 4 trials, 695 women |
Retropubic |
Research evidence favours retropubic approach. Despite reaching statistical significance, the number of studies and participants are relatively smaller than those contributing to short-term efficacy. |
| Bladder injury |
higher risk 4.5% |
lower risk 0.6% |
RR 0.13, 95% CI 0.08 to 0.20; 40 trials, 6372 women |
Obturator |
While risk of bladder injury is higher with retropubic approach, it is diagnosed intra-operatively in almost all cases, as cystoscopy is routinely employed. The tape is replaced in the correct position and no long-term problems are expected. |
| Voiding problems |
higher risk 7.2% |
lower risk 3.8% |
RR 0.53, 95% CI 0.43 to 0.65; 37 trials, 6200 women |
Obturator |
Retropubic tapes appear to be more 'obstructive'. Patients at increased risk of voiding dysfunction following surgery (using an obturator or retropubic approach) may need to learn self-catheterisation beforehand. |
| groin, pelvic and thigh pain |
lower risk 1.3%; |
higher risk 6.4% v |
RR 4.12, 95% CI 2.71 to 6.27; 18 trials, 3221 women |
Retropubic |
Chronic pain and dyspareunia appear to be the most common symptoms reported by mesh-injured women. |
| mesh exposure |
Similar risk 2.1% |
Similar risk 2.4% |
RR 1.13, 95% CI 0.78 to 1.65; 31 trials, 4743 women |
None |
None |
| mesh erosion into bladder or urethra |
Similar risk |
Similar risk |
None |
None |
|
| Operative blood loss |
Higher |
Lower |
MD 6.49 95%CI 12.33 to 0.65 |
Obturator |
The 6.5-ml statistically-significant difference in favour of the obturator approach is clinically-insignificant. |
| Operation time |
Longer |
Shorter |
MD 7.54 95%CI 9.31 to 5.77 |
Obturator |
The 7.5-minute statistically significant difference in favour of the obturator approach is thought to be due to usage of cystoscopy to rule out bladder injury during the retropubic approach. The time is thought to be well-invested. |
| Feasibility and characteristics of complete surgical removal |
Possible, regardless of duration of implantation. Removal usually requires an abdomino-perineal approach. The surgical technique and anatomy of the retropubic space are well understood by most surgeons. Removal is usually complete. |
Possible, only during the first few weeks of implantation. Removal is difficult afterwards. Removal usually requires only a perineal approach. The surgical technique and anatomy of the upper thigh are poorly understood. Removal is usually incomplete. |
Clinical Opinion (Level III) |
Retropubic |
In either condition, complete removal of the mesh device does not guarantee cure from pain. |
6.2 Conclusion
In light of the above clinical interpretation of evidence, members of the Independent Review who perform surgery for SUI are of the view that
- The retropubic approach (with diagnostic cystoscopy) is preferred when offering routine surgery for women who choose a mesh tape procedure for treatment of stress urinary incontinence.
- The transobturator approach may be offered if a retropubic approach carries additional risks e.g. organ damage in women who had prior extensive abdominal surgery.
- Regardless of the approach employed, patients with persistent groin or pelvic pain for 4-8 weeks following mesh tape insertion should be considered for timely removal surgery. Patients should be aware that even complete removal of tape does not guarantee relief of pain. All patients should be discussed by the multi-disciplinary team and referral to a regional centre may be required.
Contact
Email: Gillian McCallum
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