Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)

Glazener, Cathryn; Breeman, Suzanne; Elders, Andrew; Hemming, Christine; Cooper, Kevin; Freeman, Robert; Smith, Anthony; Reid, Fiona; Hagen, Suzanne; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; McDonald, Alison; McPherson, Gladys; MacLennan, Graeme; Norrie, John

doi:10.1016/s0140-6736(16)31596-3

Cited by 224 publications

(197 citation statements)

References 22 publications

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“…The results of our study confirm the low rate of recurrence after implantation of an alloplastic mesh for cystocele repair described in the AWMF guidelines compared to conventional anterior colporrhaphy, which has a recurrence rate of up to 30 % [1,25]. In contrast, the recently published PROSPECT study found no benefit for mesh-based procedures compared to conventional methods [26]. They found no significant differences with regard to undesirable events, rates of dyspareunia and recurrence, and the number of repeat operations.…”

Section: Discussionsupporting

confidence: 84%

“…At 12 and 36 months after the procedure, the quality of life of the surveyed study participants had improved even more, and the difference to the preoperative figures remained significant. Further studies have also confirmed that mesh-based correction of pelvic organ prolapse can significantly improve patientsʼ quality of life, despite mesh-associated side-effects [26][27][28][29][30][31].…”

Section: Discussionmentioning

confidence: 83%

“…They found no significant differences with regard to undesirable events, rates of dyspareunia and recurrence, and the number of repeat operations. However, the authors reported that a repeat operation for mesh-induced complications was necessary in 9 % of women [26]. It should be noted that 75 % of patients with erosion which required surgical removal of the visible aspect were asymptomatic.…”

Section: Discussionmentioning

confidence: 98%

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Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months

Fünfgeld¹,

Stehle²,

Henne

et al. 2017

Geburtshilfe Frauenheilkd

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ABSTR AC TIntroduction Pelvic organ prolapse can significantly reduce quality of life of affected women, with many cases requiring corrective surgery. The rate of recurrence is relatively high after conventional prolapse surgery. In recent years, alloplastic meshes have increasingly been implanted to stabilize the pelvic floor, which has led to considerable improvement of anatomical results. But the potential for mesh-induced risks has led to a controversial discussion on the use of surgical meshes in urogynecology. The impact of cystocele correction and implantation of an alloplastic mesh on patientsʼ quality of life/sexuality and the long-term stability of this approach were investigated. MethodIn a large prospective multicenter study, 289 patients with symptomatic cystocele underwent surgery with implantation of a titanized polypropylene mesh (TiLOOP ® Total 6, pfm medical ag) and followed up for 36 months. Both primary procedures and procedures for recurrence were included in the study. Anatomical outcomes were quantified using the POP-Q system. Quality of life including sexuality were assessed using the German version of the validated P-QoL questionnaire. All adverse events were assessed by an independent clinical event committee.Results Mean patient age was 67 ± 8 years. Quality of life improved significantly over the course of the study in all investigated areas, including sexuality and personal relationships (p < 0.001, Wilcoxon test). The number of adverse events which occurred in the period between 12 and 36 months after surgery was low, with just 22 events reported. The recurrence rate for the anterior compartment was 4.5 %. Previous or concomitant hysterectomy increased the risk of recurrence in the posterior compartment 2.8-fold and increased the risk of erosion 2.25-fold.Conclusion Cystocele correction using a 2nd generation alloplastic mesh achieved good anatomical and functional results in cases requiring stabilization of the pelvic floor and in patients with recurrence. The rate of recurrence was low, the patientsʼ quality of life improved significantly, and the risks were acceptable. . The most serious effect of pelvic organ prolapse is impairment of bladder and bowel function accompanied by incontinence and voiding disorders [2,3]. General well-being, personal relationships, particularly sexuality [4], and physical and social activities often suffer from the effects of prolapse [5,6]. The incidence of pelvic organ prolapse in women has increased in parallel with the general increase in life expectancy, and the likelihood that women aged 80 years will require surgical intervention (e.g. hysterectomy, pelvic floor reconstruction) is 12.2 % [7]. One in nine women is affected by prolapse [8]. Up to 30 % of patients require a repeat operation for recurrence within 5 years of the original procedure [9][10][11][12]. Surgical correction of prolapse should not just reposition the prolapsed pelvic organs, it should also restore the patientʼs quality of life or at least improve it. As the recurrence rate...

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 98%

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Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months

Fünfgeld¹,

Stehle²,

Henne

et al. 2017

Geburtshilfe Frauenheilkd

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“…13,14 A recent randomized clinical trial compared mesh and non-mesh transvaginal prolapse repair and found that there was no difference in objective or subjective outcomes, and that 1/10 patients who had mesh-augmented repairs had secondary surgery for mesh complications. 15 Placement of transvaginal mesh may still be indicated in select cases; for example, in the setting of recurrent prolapse in which an abdominal sacrocolpopexy is contraindicated.…”

Section: Cua Position Statement Regarding the Use Of Transvaginal Mesmentioning

confidence: 99%

Canadian Urological Association position statement on the use of transvaginal mesh

Welk

Carlson

Baverstock

et al. 2017

CUAJ

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Stress incontinence (SUI) and pelvic organ prolapse (POP) are common conditions. There is high-level evidence that midurethral mesh slings for stress incontinence are effective and safe; however, the rare but serious potential risks of this surgery must be discussed with the patient. The use of transvaginal mesh for prolapse repair does not appear to be supported by the current evidence, and its use should be restricted to specialized pelvic floor surgeons and specific clinical situations.

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“…Going back to native tissue repair is clearly not the answer. The Lancet Prolapse Surgery: Pragmatic Evaluation and Randomised Controlled Trials (PROSPECT) [1] proved the futility of surgical intervention to the vagina with >80% failure rate at 6 months and further attrition at 1 year.…”

mentioning

confidence: 99%

Should surgeons continue to implant mesh sheets behind the vagina?

2018

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Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)

Abstract: UK National Institute of Health Research.

Cited by 224 publications

References 22 publications

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months

Canadian Urological Association position statement on the use of transvaginal mesh

Should surgeons continue to implant mesh sheets behind the vagina?

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