Transvaginal mesh surgery for pelvic organ prolapse��Prolift+M: a prospective clinical trial

Introduction and hypothesis  

This study deals with assessment of safety, efficacy, and potential complications of Prolift+M system to correct uterovaginal prolapse.     

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.     

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.     

Association between pelvic floor muscle trauma and pelvic organ prolapse 20 years after delivery

Introduction and hypothesis

It is known that pelvic floor muscle trauma (PFMT) after vaginal delivery is associated with pelvic organ prolapse (POP) symptoms (sPOP) and signs (POP-Q ≥2) in patient populations. Our aims were to establish the prevalence and investigate a possible association between PFMT and sPOP and POP-Q ≥2 in healthy women 20 years after their first delivery.

Methods

During 2013 and 2014 we conducted a cross-sectional study among 847 women who delivered their first child between 1990 and 1997. Women responded to a postal questionnaire and were offered a clinical examination including prolapse grading and pelvic floor ultrasonography. The main outcome measures were sPOP, POP-Q ≥2 and PFMT, defined by levator avulsion or a levator hiatal area on Valsalva manoeuvre of >40 cm² on ultrasonography.

Results

Of the 847 eligible women, 608 (72 %) were examined. Data on POP symptoms, POP-Q stage, levator avulsion and levator hiatal area were available in 598, 608, 606 and 554 women, respectively, and of these 75 (13 %) had sPOP, 275 (45 %) had POP-Q ≥2, 113 (19 %) had levator avulsion and 164 (30 %) had a levator hiatal area >40 cm². Levator avulsion was associated with POP-Q ≥2 with an odds ratio (OR) of 9.91 and a 95 % confidence interval (CI) of 5.73 – 17.13, and with sPOP (OR 2.28, 95 % CI 1.34 – 3.91). Levator hiatal area >40 cm² was associated with POP-Q ≥2 (OR 6.98, 95 % CI 4.54, – 10.74) and sPOP (OR 3.28, 95 % CI 1.96 – 5.50).

Conclusion

Many healthy women selected from the general population have symptoms and signs of POP 20 years after their first delivery, and PFMT is associated with POP-Q ≥2 and sPOP.

     

Associated pelvic organ prolapse in women with stress urinary incontinence: when to operate?

PURPOSE OF REVIEW: This review discusses recently published data concerning the indications for pelvic organ prolapse (POP) surgery in women who present with stress urinary incontinence (SUI). RECENT FINDINGS: POP can functionally mask SUI. Surgery for POP may unmask occult SUI in many women. Clinically continent women undergoing POP surgery are at risk for developing symptomatic SUI postoperatively. Preoperative identification of occult (and overt) SUI will facilitate the use of an appropriate prophylactic anti-incontinence procedure at the time of prolapse repair. Numerous studies on the preoperative prediction of SUI following repair of POP have been conducted in an effort to determine whether concomitant prophylactic measures should be taken at the time of POP repair to prevent the postoperative unmasking of SUI in women who do not have SUI preoperatively (with or without prolapse reduction). Although the literary evidence available is not sufficient for POP with occult SUI, there is some information available to guide clinicians in deciding when to perform concurrent POP surgery in women who are undergoing primary surgery for SUI. SUMMARY: The intended goal of surgical correction of SUI and POP is durable restoration of normal anatomy and function, with symptomatic relief and avoidance of morbidity. Recommendations regarding when to surgically intervene for POP in women who present with SUI are based on the available literature although contemporary studies are few and include small numbers of patients with no controls. Long-term, randomized, controlled prospective studies of large numbers of patients are indicated.     

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.     

Does pelvic organ prolapse quantification exam predict urethral mobility in stages 0 and I prolapse?

Objective: To determine if women with anterior support stages 0 or I by pelvic organ prolapse quantification (POP-Q) system require Q-tip testing to assess urethral mobility. Methods: A prospective study of 134 women presenting for urogynecologic evaluation were examined and assigned stages of anterior wall support according to the POP-Q system. A Q-tip test was performed and urethral hypermobility was defined as a straining angle 30°. The Spearman correlation coefficient was used to assess degree of correlation between POP-Q point Aa position and Q-tip values. Results: The correlation coefficient between point Aa position and Q-tip angle was r=0.787 (P<0.001). Urethral hypermobility was noted in 91% of stage I and 100% of stage II–IV patients. The positive predictive value of Q-tip angle 30° in stage I–IV prolapse was 99%. Conclusion: The POP-Q system is highly predictive of straining urethral angle in all stages of prolapse.     

Is hysterectomy or prior reconstructive surgery associated with unsuccessful initial trial of pessary fitting in women with symptomatic pelvic organ prolapse?

Introduction and hypothesis

There is little data in the literature regarding the feasibility and limitations of pessary therapy after pelvic reconstructive surgery for symptom recurrence for treating urinary incontinence. Hysterectomy is an important risk factor for failure of pessary fitting. We aimed to evaluate the influence of these prior surgeries on subsequent initial trials of fitting a pessary.

Methods

Six hundred and twenty-nine women with symptomatic pelvic organ prolapse (POP) were included in a prospective cohort study from January 2014 to December 2015. All women had symptomatic stage ≥2 POP. During the study period, various types of pessaries were used for the fitting process.

Results

O the 629 women, 489 (77.7 %) had neither hysterectomy nor reconstructive pelvic surgery, and 24 (3.8 %) had hysterectomy for different indications. Initial pessary fitting was possible in all patients in both groups (100 %) 116 (18.4 %) had a total of 159 previous, predominantly vaginal, surgeries for POP, with or without vaginal hysterectomy. In 25/116 (21.5 %) cases, initial fitting was impossible due to altered anatomy. After one surgery, the probability of failure was 18.8 % (15/80) and after two 27.3 % (9/33). Of the three women who had three or more surgeries, one failure occurred.

Conclusion

Surgery for POP is an important risk factor for an unsuccessful pessary fitting. It seems conclusive to recommend pessary treatment as a general first-line therapy for symptomatic POP, since after unsuccessful pessary treatment, women can still undergo surgery, whereas reversing treatment options might not always be feasible.

     

Which factors determine subjective improvement following pelvic organ prolapse 1?year after surgery?

Introduction and hypothesis  

The factors influencing a patient’s subjective improvement 1 year after pelvic organ prolapse (POP) surgery were studied.     

Levator ani defect scores and pelvic organ prolapse: is there a threshold effect?

Introduction and hypothesis

The goal of this study was to use a well-described system of quantifying levator ani defect (LAD) severity using magnetic resonance imaging (MRI) to examine the relationship between defect severity and the presence or absence of prolapse.

Methods

This is a secondary analysis of two case–control studies comparing 284 cases (with prolapse) to 219 controls (normal support) defined by using Pelvic Organ Prolapse Quantification (POP-Q) exams. LAD were assessed on MRI, with scores from 0 (no defects) to 6 (complete, bilateral defects). The number of cases and controls at each score were compared. Logistic regression and receiver operating characteristic (ROC) analyses were used to quantify relationships between LAD and prolapse.

Results

The proportion of cases exceeds the overall prolapse rate in this study at LAD scores ≥3, with higher rates of prolapse at higher LAD scores (p?p?Conclusions There are three clusters of prolapse risk: low (0–2), moderate (3–5), and high (6). Although LAD have a dose-response-like effect for prolapse, other factors are clearly involved.     

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.     

Does COLIA1 SP1-binding site polymorphism predispose women to pelvic organ prolapse?

Introduction and hypothesis  COLIA1 polymorphism is associated with increased risk for stress urinary incontinence. We hypothesize that a similar association exists with pelvic organ prolapse (POP). Methods  Patients with advanced prolapse and healthy controls were evaluated by interview, validated questionnaires, and pelvic examination. DNA was extracted from peripheral blood, and polymerase chain reaction was performed to determine the presence or absence of the polymorphism. Power calculation indicated the need for 36 patients in each arm. Results  The prevalence of the polymorphic heterozygous genotype (GT) in the study and control groups was 33.3% and 19.4%, respectively, leading to an odds ratio of 1.75. This difference, however, did not reach statistical significance (p = 0.27). Conclusions  The COLIA1 polymorphism was not significantly associated with increased risk for POP.     

Patient reported outcome measures in women undergoing surgery for urinary incontinence and pelvic organ prolapse in Denmark, 2006–2011

Introduction and hypothesis

The aim of this study was to evaluate the impact of urogynecological surgery on quality of life based on patient reported outcome measures (PROMs).

Methods

Data were retrieved from the Danish Urogynaecological Database. Inclusion criteria were Danish women undergoing surgery for urinary incontinence (UI) or pelvic organ prolapse (POP) from 2006 to 2011. Using frequency of symptoms and a visual analogue scale (VAS) both pre- and postoperatively, their severity of symptoms and quality of life were measured by questionnaires.

Results

During the study period, 20,629 urogynecological procedures were performed. The questionnaires on severity of symptoms and the VAS had been completed both pre- and postoperatively for approximately one third of women undergoing surgery. For UI surgery, 83 % had improved symptoms, 13 % were unchanged, and 4 % had worse symptoms postoperatively. For POP surgery, 80, 17, and 3 % were improved, unchanged, and worsened, respectively. The postoperative bother of symptoms and interference in everyday life evaluated by VAS were significantly reduced for both UI [preoperative median VAS score 9, postoperative median score 1 (p?<?0.001)] and POP [8 preoperatively and 0 postoperatively (p?<?0.001)].

Conclusions

Based on PROMs, surgery for UI and POP is effective in alleviating symptoms associated with UI or POP, and it can improve quality of life in symptomatic women. Pre- and postoperative questionnaires are useful tools in assessing symptomatic outcome measures after surgery.     

Perineal descent and patients’ symptoms of anorectal dysfunction, pelvic organ prolapse, and urinary incontinence

Introduction and hypothesis  

The aim of this dynamic magnetic resonance (MR) imaging study was to assess the relation between the position and mobility of the perineum and patients’ symptoms of pelvic floor dysfunction.     

Urodynamic indices and pelvic organ prolapse quantification 3?months after vaginal delivery in primiparous women

Introduction and hypothesis

This study aims to describe multichannel urodynamic indices and pelvic organ prolapse quantification (POP-Q) in primiparous women 3?months after vaginal delivery.

Methods

This was a secondary analysis of a group of women who had been randomized to either coached or non-coached pushing during the second stage of labor. Primiparous women were evaluated with POP-Q examination and multichannel urodynamic testing 3?months after vaginal delivery.

Results

Of 128 women evaluated, the cumulative stage of prolapse was distributed as 4.7% stage 0, 39% stage I, 56% stage II, and none with stage III prolapse or greater. For the anterior compartment, most had stage II prolapse. Stage I prolapse predominated for both the central and posterior compartments. Of the women, 14.1% had urodynamic stress incontinence, 12.5% had detrusor overactivity, and 6% had both.

Conclusions

In a predominantly Hispanic primiparous population, ICS POP-Q stage II prolapse of the vagina, urodynamic stress incontinence, and detrusor overactivity are common findings at a 3-month postpartum assessment.