Use of the Gynecare Prolift? system in surgery for pelvic organ prolapse: 1-year outcome

Introduction and hypothesis  

This retrospective study reports the 1-year outcome in women who underwent mesh-augmented Prolift? surgery performed from 2006 to 2008. There were a total of 254 patients, with 128, 106 and 20 patients receiving total, anterior and posterior Prolift?, respectively.     

The cube pessary: an underestimated treatment option for pelvic organ prolapse? Subjective 1-year outcomes

Introduction and hypothesis

Pelvic organ prolapse (POP) is a common condition. The use of pessaries for conservative management of POP is widespread. However, there are little data on the use of cube pessaries. The aim of our study was to evaluate whether self-therapy with the use of vaginal cube pessaries in women with POP can be a well-tolerated, first-line treatment.

Methods

In a prospective case series, 87 women who suffered from symptomatic POP, stages II–IV, were instructed in self-treatment with a vaginal cube pessary. Differences were analyzed using Wilcoxon’s rank sum test or Fisher’s exact test.

Results

A pessary could be fitted in 84/87 patients (96.6 %); 6 women were lost to follow-up. The remaining 78 patients (92.9 %, median age 60 years) completed the study. Sixteen women (20.5 %) chose not to continue with the pessary treatment. For these patients, general well-being decreased from a median numeric rating score (NRS) of 4.5 (3–6) to 2.0 (1–3, p?<?0.001). In those who continued treatment, general well-being increased from a median NRS of 3.0 (2–5) to 8.0 (7–10, p?<?0.001) after 1 year of use. The majority of patients (53) in the present study rated pessary self-care use as “very easy” or “easy” (85.5 %). The Patient Global Impression of Improvement (PGI-I) was 2.0 (1–3) at follow-up examination. There were no complications or adverse effects of pessary use.

Conclusions

Conservative self-treatment with vaginal cube pessaries might be a feasible treatment option for women who suffer from POP.     

Trocarless system for mesh attachment in pelvic organ prolapse repair��1-year evaluation

Introduction and hypothesis  

EndoFast Reliant™ system is a novel technology for pelvic organ prolapse (POP) repair that attaches mesh directly with metal fasteners.     

Where to for pelvic organ prolapse treatment after the FDA pronouncements?

Introduction

With the publication of the updated US Food and Drug Administration (FDA) communication in 2011 on the use of transvaginal placement of mesh for pelvic organ prolapse (POP) it is appropriate to now review recent studies of good quality on POP to assess the safety and effectiveness of treatment options and determine their place in management.

Methods

A systematic search for studies on the conservative and surgical management of POP published in the English literature between January 2002 and October 2012 was performed. Studies included were review articles, randomized controlled trials, prospective and relevant retrospective studies as well as conference abstracts. Selected articles were appraised by the authors regarding clinical relevance.

Results

Prospective comparative studies show that vaginal pessaries constitute an effective and safe treatment for POP and should be offered as first treatment of choice in women with symptomatic POP. However, a pessary will have to be used for the patient’s lifetime. Abdominal sacral colpopexy is effective in treating apical prolapse with an acceptable benefit-risk ratio. This procedure should be balanced against the low but non-negligible risk of serious complications. The results of native tissue vaginal POP repair are better than previously thought with high patient satisfaction and acceptable reoperation rates. The insertion of mesh at the time of anterior vaginal wall repair reduces the awareness of prolapse as well as the risk of recurrent anterior prolapse. There is no difference in anatomic and subjective outcome when native tissue vaginal repairs are compared with multicompartment vaginal mesh. Mesh exposure is still a significant problem requiring surgical excision in approximately ≥10 % of cases. The ideal mesh has not yet been found necessitating more basic research into mesh properties and host response. Several studies indicate that greater surgical experience is correlated with fewer mesh complications. In women with uterovaginal prolapse uterine preservation is a feasible option which women should be offered. Randomized studies with long-term follow-up are advisable to establish the place of uterine preservation in POP surgery.

Conclusion

Over the last decade treatment of POP has been dominated by the use of mesh. Conservative treatment is the first option in women with POP. Surgical repair with or without mesh generally results in good short-term objective and functional outcomes. However, basic research into mesh properties with host response and comparative studies with long-term follow-up are urgently needed.     

Women’s experiences of doing long-term pelvic floor muscle exercises for the treatment of pelvic organ prolapse symptoms

Introduction and hypothesis

This study investigated women’s experiences of doing prescribed pelvic floor muscle exercise (PFME) after participation in the Pelvic Organ Prolapse Physiotherapy (POPPY) trial. The aim was to understand post-supervised treatment adherence to PFME and to inform future advice for women being treated for pelvic organ prolapse (POP).

Methods

Five women were purposively selected from the New Zealand branch of the multi-centre, multi-national POPPY trial and took part in a semi-structured interviews about their experiences of PFME. The interviews were subjected to an interpretative phenomenological analysis (IPA).

Results

Three core themes were identified in the analysis. The first theme, “Patterns of PFME behaviour”, described exercise characteristics and behaviours. The second theme, “Influences on PFME maintenance cycles”, captured the participants’ responses to and evaluations of their exercise practice and related PFME self-efficacy. The “cycle” referred to the changing influences on exercise behaviour. The third theme, “Family as priority”, was expressed in terms of either putting family first or successfully combining the priorities of family and self.

Conclusion

This study revealed the importance of family in influencing PFME patterns and behaviours in the treatment of POP. It is possible that identifying strategies to help women reach their PFME goals within the context of their families will promote more successful PFME adherence. The importance of family when prescribing exercise for women with other chronic health conditions is also worth exploring.     

Labhardt’s colpoperineocleisis: subjective results of an alternative treatment for genital prolapse in patients who are not sexually active—2-year follow-up

Introduction and hypothesis

Genital prolapse affects up to 50 % of multiparous women and has an impact on quality of life (QoL) for many. Vaginal obliterative techniques are relevant in older patients who are not sexually active. We performed Labhardt’s colpoperineocleisis in such patients. The objective was the evaluation of subjective outcomes of this technique using PGI-I.

Methods

Retrospective cohort analysis of patients. We performed a bivariate, multivariate analysis, and survival curves for subjective improvement.

Results

Seventy-four cases were analyzed. Average age of the patients was 72 years, median parity 4, 95.9 % POP-Q stage III or IV, anterior leading edge defect in 61.1 %. Operating time: 54 min, estimated blood loss 70 ml, no intraoperative complications, 12 patients had protocol deviations with changes in the recommended type of suture. Median hospital stay was 2 days and average follow-up 24.9 months. There was 13.5 % anatomical recurrence, 3 of which (30 %) were in patients with protocol deviations. 1.9 % developed clinically significant de novo stress urinary incontinence (SUI). PGI-I: 64 (86 %) reported subjective improvement and 10 did not. In the subjective improvement group, 98.4 % reported being very much or much better. In the non-subjective improvement group 80 % reported that they were the same as before surgery and 20 % were worse. In bivariate analysis anatomical recurrence showed significance and persisted after multivariate analysis with an OR of 8322 for subjective failure.

Conclusion

Labhardt’s colpoperineocleisis is a safe technique with good subjective results. It has few complications, an acceptable recurrence rate, and a low rate of de novo SUI. It may be important to use the #0 or #1 polydioxanone sutures, as these are associated with better outcomes in this series. Comparative studies with other obliterative techniques are needed.     

Comparing different tissue-engineered repair materials for the treatment of pelvic organ prolapse and urinary incontinence: which material is better?

Introduction and hypothesis

Synthetic non-absorbable meshes are widely used to augment surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but these meshes are associated with serious complications. This study compares the attachment and extracellular matrix (ECM) production of adipose-derived stem cells (ADSCs) on different biodegradable nanomaterials to develop tissue engineered repair materials.

Methods

Rat ADSCs were isolated and cultured on electrospun poly-L-lactic acid (PLA) and electrospun poly(L-lactide)-trimethylene carbonate-gycolide (PLTG) terpolymers for 1 and 2 weeks. Samples were tested for cell proliferation (cell counting kit-8), microstructure, and morphology (scanning electron microscopy), production of ECM components (immunostaining for collagen I, collagen III, and elastin) and biomechanical properties (uniaxial tensile methods).

Results

The ADSCs showed good attachment and proliferation on both PLA and PLTG scaffolds. The production of collagen I and collagen III on both scaffolds was greater at 14 days than at 7 days and was greater on PLTG scaffolds than on PLA scaffolds, but these differences were not significant. The addition of ADSCs onto scaffolds led to a significant increase in the biomechanical properties of both PLA and PLTG scaffolds compared with unseeded scaffolds.

Conclusion

These data support the use of both PLA and PLTG as tissue-engineered repair materials for POP or SUI.

     

Reoperation for pelvic organ prolapse: a Danish cohort study with 15–20 years’ follow-up

Introduction and hypothesis

The objectives were to determine the reoperation rate of primary pelvic organ prolapse (POP) surgery, to describe the age distribution of the women at primary surgery for those undergoing a reoperation, and to describe the incidence of second and third reoperations.

Methods

We carried out a population-based registry study of Danish women above the age of 18 years when undergoing primary surgery for POP during the period 1996–2000. Data were retrieved from the Danish National Patient Register. All women were followed until one of the following events occurred: reoperation for POP, death, emigration, or end of follow-up period. Reoperation was defined as “repeated surgery in same compartment”. The cumulative incidence rate of reoperation was divided into three compartments (anterior, apical, and posterior) and was calculated using Kaplan–Meier plots.

Results

A total of 18,382 procedures were performed on 11,805 women. After 20 years’ follow-up, the cumulated incidence rate of reoperation for POP in the anterior, apical, and posterior compartments was 12.4%, 7.9%, and 12.1% respectively. The overall rate of reoperation was 11.5%. Of women aged between 18 and 49 years of age at primary surgery, 26.9% had a reoperation, whereas in women between 50 and 90+ years of age at primary surgery, only 10.1% had a reoperation.

Conclusions

This large study with up to 20 years’ follow-up has found that reoperation for POP is modest, that the reoperation rate is lowest for the apical compartment, but highest in all three compartments during the first year after primary surgery. The reoperation rate peaks in the group of women who had their primary surgery before the menopause in all three compartments.

     

Changes in connective tissue in patients with pelvic organ prolapse—a review of the current literature

Little is known about the pathophysiology of pelvic organ prolapse (POP). In 1996, Jackson presented a hypothesis on pelvic floor connective tissue that tried to explain the development of POP on a molecular level. The objective of this review is to test the hypothesis against recent literature. The method used was a review of literature. The association between POP and connective tissue metabolism is well established. However, the causality of this association is unclear. The characteristics of the pelvic floor connective tissue of POP patients relate to tissue repair. To resolve the question of cause and effect, the role of fibroblasts in producing the extracellular matrix should be clarified. With these data, the use of autologous or allogenic stem cells in the treatment of POP may come in sight. Recent literature supports the hypothesis of Jackson but does not resolve long-standing questions on the aetiology of POP.     

High tibial osteotomy for the treatment of medial osteoarthritis of the knee with new iBalance system: 2 years of follow-up

Background

A new system for performing open-wedge high tibial osteotomy (HTO), the iBalance HTO System-Arthrex, has been recently developed in order to make the surgery more reproducible and safe. The aim of this study was to determine the short-term outcomes of the iBalance technique in medial compartment osteoarthritis and varus malalignment of the knee.

Methods

Fifteen patients with a mean age of 50.7 years (SD 5.09), affected by symptomatic varus knee, with medial compartment osteoarthritis (1–2 Ahlbäck degree), were treated with iBalance HTO between July 2011 and February 2012 and evaluated retrospectively. Patients were assessed against the following benchmarks: subjective International Knee Documentation Committee (IKDC) score, Knee injury and Osteoarthritis Outcome Score (KOOS), and VAS for pain and Tegner scores, along with X-rays and MRI, before surgery and after a 2-year follow-up.

Results

No severe intraoperative complications or implant failures occurred. The mean preoperative scores were as follows: subjective IKDC 66.8 (SD 1.18), KOOS 61.3 (SD 0.86), Vas for pain 8.6 (SD 1.72) and Tegner 4.1 (SD 2.06), while at follow-up the scores were 73.6 (SD 1.01), 88.1 (SD 1.23), 2.9 (SD 2.35) and 3.1 (SD 1.83), respectively. Correction ranged between 3° and 8°. All patients showed complete articular recovery, no loss of correction, no substantial variation in A/P slope and no hardware problems.

Conclusions

iBalance proved to be effective and safe and produced good overall results. Consolidation and osseointegration of the system took place rapidly, while recovery was precocious, comparable with traditional methods and with no severe complications.

Level of evidence

Case series, Level IV.