How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial.

OBJECTIVE: To report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs. DESIGN: Secondary analysis of the PROSPECT randomised controlled trial and cohort study. SETTING: Thirty-five UK hospitals. POPULATION: A total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair. METHODS: Event rates were calculated for all complications. Analysis was by treatment received. MAIN OUTCOME MEASURES: IUGA/ICS classification of complications and validated patient reported outcome measures. RESULTS: At baseline, 8.4% of women had 'generic' pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re-admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re-admission were vaginal adhesions, urinary retention, infection and constipation. CONCLUSIONS: This is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications. TWEETABLE ABSTRACT: A prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.

Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).

OBJECTIVE: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN: Randomised controlled trial. SETTING: Thirty-three UK hospitals. POPULATION: Women having surgery for recurrent prolapse. METHODS: Women recruited using remote randomisation. MAIN OUTCOME MEASURES: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.

Procidentia in pregnancy: a systematic review and recommendations for practice.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) in pregnancy is a rare condition with decreasing incidence and improved management and outcome world-wide recently. Systematic review of the literature for cases of POP in pregnancy published since 1990 was carried out to identify common factors in presentation, management and outcomes. One case from our own practice was added to the analysis. METHODS: An extensive search of the Pubmed/Medline, Scopus and Google Scholar databases was performed to identify all cases of POP in pregnancy since 1990. Published case reports of POP in pregnancy were reviewed and summarized in tables to find similarities in history, course, management and outcome of the pregnancies. RESULTS: Of the 43 cases and one case series, 41 case studies were eligible for analysis. Two types of POP in pregnancy were identified: preexisting is less common (14 vs 27 cases), often resolves during pregnancy (5 out of 14) and always recurs after delivery (14 out of 14); acute onset of POP in pregnancy rarely resolves in pregnancy (2 out of 27), but often resolves after delivery (18 out of 27). Most patients were managed with bed rest (20 out of 41), pessary (15 out of 41), manual reduction (6 out of 41) and local treatment (6 out of 41). The most common complications reported include preterm labour (14 out of 41), cervical ulcerations (9 out of 41), infection (3 out of 41) and obstructed labour (4 out of 41). About a half of the women delivered vaginally (22 out of 41), caesarean section due to prolapse was required in 15 cases. CONCLUSIONS: Two distinct entities were identified based on similarities regarding onset, course and outcome of POP in pregnancy. Concise recommendations for practice were derived from the analysis of case studies published since 1990.

Prevention of postpartum stress incontinence in primigravidae with increased bladder neck mobility: a randomised controlled trial of antenatal pelvic floor exercises.

OBJECTIVE: To test whether supervised pelvic floor exercises antenatally will reduce the incidence of postpartum stress incontinence in at-risk primigravidae with bladder neck mobility, ultrasonically proven. DESIGN: Single blind, randomised controlled trial. SETTING: Antenatal clinic in a UK NHS Trust Hospital. SAMPLE: Two hundred and sixty-eight primigravidae attending an antenatal clinic at approximately 20 weeks of gestation with bladder neck mobility, on standardised valsalva, of 5 mm or more linear movement. The median age was 28, ranging from 16 to 47 years. INTERVENTION: Patients randomised to supervised pelvic floor exercises (n = 139) attended a physiotherapist at monthly intervals from 20 weeks until delivery. The exercises comprised three repetitions of eight contractions each held for six seconds, with two minutes rest between repetitions. These were repeated twice daily. At 34 weeks of gestation the number of contractions per repetition was increased to 12. Both the untreated control group and the study group received verbal advice on pelvic floor exercises from their midwives antenatally. MAIN OUTCOME MEASURES: Subjective reporting of stress incontinence at three months postpartum. Pelvic floor strength, using perineometry, and bladder neck mobility measured by perineal ultrasound. RESULTS: Of the 268 women enrolled, information on the main outcome variable was available for 110 in the control group and 120 in the study group. Fewer women in the supervised pelvic floor exercise group reported postpartum stress incontinence, 19.2% compared with 32.7% in the control group (RR 0.59 [0.37-0.92]). There was no change in bladder neck mobility and no difference in pelvic floor strength between groups after exercise, although all those developing postpartum stress incontinence had significantly poorer perineometry scores than those who were continent. CONCLUSIONS: The findings suggest that antenatal supervised pelvic floor exercises are effective in reducing the risk of postpartum stress incontinence in primigravidae with bladder neck mobility.

How often should shelf/Gellhorn pessaries be changed? A survey of IUGA urogynaecologists.

INTRODUCTION AND HYPOTHESIS: Gellhorn and shelf pessaries can be effective management for women with pelvic organ prolapse (POP). This study aimed to investigate the opinion of IUGA members about shelf/Gellhorn pessary use, and in particular, how often to change them in patients with POP. There are no evidence-based guidelines available on this subject. METHODS: Members of the International Urogynaecology Association (IUGA) and the British Society of Urogynaecology (BSUG) were sent a single electronic mailing of semi-structured questionnaires containing closed and open questions and free text response boxes. The internet-based survey consisted of 13 questions. Free text responses were analysed using a thematic qualitative analysis. RESULTS: A total of 322 respondents from the IUGA membership participated in the survey. Most consider shelf/Gellhorn pessaries an effective first-line treatment for their patients with POP. Self care is usually acceptable with ring pessaries, but with shelf/Gellhorn, 35 % would like to change them every 3 months, 31 % every 6 months and the rest varied. The routine use of oestrogens along with shelf/Gellhorn pessaries is a common practice. The risk of urogenital fistulae is well documented, but overall clinicians felt that shelf/Gellhorn pessaries are a safe and effective treatment for POP. CONCLUSIONS: This study highlights the wide variation in global practice of the management of shelf/Gellhorn pessaries for POP. In order to inform our practice, evidence-based guidelines are required. A randomised control trial may help to decide whether or not it is appropriate to change the shelf/Gellhorn pessaries at all.

Cutting a mediolateral episiotomy at the correct angle: evaluation of a new device, the Episcissors-60.

BACKGROUND: Anal incontinence is nine times more prevalent in women than in men due to obstetric anal sphincter injury (OASI). OASI is linked to midline episiotomies and mediolateral episiotomies with post-delivery angles of <30 and >60 degrees. Studies show that doctors and midwives are unable to correctly "eyeball" the safe angle required due to perineal stretching by the fetal head at crowning. A new scissor instrument (Episcissors-60) was devised to allow cutting a mediolateral episiotomy at a fixed angle of 60 degrees from the perineal midline. METHODS: Scissors with a marker guide limb pointing towards the anus were devised, ensuring an angle of 60 degrees between the scissor blades and the guide limb. This device was initially tested in models. Post-delivery angles were recorded on transparencies and analyzed by an author blinded to clinical details. Accoucheurs were asked to rate the ease of use on a 5-point scale. RESULTS: Of the 17 women, 14 delivered with ventouse, two with forceps, and one with sequential ventouse-forceps. Indications for instrumental delivery were suboptimal cardiotocogram and/or prolonged second stage of labor. Mean birth weight was 3.41 (2.92-4.12) kg. A mean post-delivery angle of 42.4±7 (range 30-60, median 43) degrees (95% confidence interval 38.8-46) was achieved with the Episcissors-60 instrument. Eighty-eight percent of clinicians agreed or strongly agreed that the scissors were easy to use. CONCLUSION: The Episcissors-60 delivered a consistent post-delivery angle of 43 degrees. They could replace "eyeballing" when performing mediolateral episiotomies and form part of a preventative strategy to reduce OASI.

Is anatomical failure following anterior vaginal repair associated with weak native vaginal tissues? A biomechanical and immunohistochemical study.

INTRODUCTION AND HYPOTHESIS: This study was performed to determine whether anatomical recurrence of cystocoele 1 year after anterior vaginal repair is related to biomechanical properties and/or the content of collagen in the vaginal wall and epithelial tissues. METHODS: In this prospective, observational study in a UK teaching hospital, we assessed women undergoing surgery for symptomatic anterior compartment prolapse. Outcome measures were anatomical recurrence, biomechanical strength and collagen content in vaginal tissues. In part one of the study, 42 women underwent biomechanical testing of full-thickness anterior vaginal wall tissue samples to determine the elastic moduli and yield stress. In part two, 59 women underwent immunohistochemical testing of anterior vaginal wall tissue samples to determine tissue content of procollagen I; collagen types I, III, V; and matrix metalloproteinases 1 and 2 (MMP-1 and 2). Results were then compared with anatomical outcome at 1 year postsurgery. RESULTS: Differences in yield strain in all outcome groups (optimal, satisfactory and unsatisfactory) were not statistically significant. Considerable variation was found in collagen type I in both satisfactory and unsatisfactory groups. There was no difference or correlation with procollagen, collagen types III and V, and MMP-1 and recurrence of pelvic organ prolapse (POP) between groups. There was a weak correlation between collagen type I and higher yield stress in both groups. CONCLUSIONS: Anatomical failure of anterior repair does not appear to be related to the biomechanical strength or collagen content of the anterior vaginal wall.

Is there a need for postoperative follow-up after routine urogynaecological procedures? Patients will self-present if they have problems.

INTRODUCTION AND HYPOTHESIS: The value of outpatient appointments for postoperative review has been questioned for many years, and the surgeon practice around this issue is varied. The aim of this study, as part of a larger study assessing postoperative follow-up, was to assess how many patients self-present to their general practitioner (GP) or the emergency department after surgery for urogynaecology procedures. METHODS: A retrospective observational study of postoperative urogynaecology patients between 2007 and 2012 was performed using the British Society of Urogynaecology (BSUG) database to identify patients. These records were correlated with hospital and GP records to assess whether any patient was seen postoperatively for a procedure-related problem. RESULTS: There were 244 patients with complete data on the BSUG database, of whom 25 (10 %) presented to hospital/secondary care in the year following their surgery; only three of these were admitted for problems related to their surgery. There was a response rate of 70 % from GPs for access to their records. This represented 171 patients, 90 of whom (52.3 %) presented to their GP within a year of surgery mostly for a minor procedure-related event: 11 of these were re-referred to secondary care, and the remainder were treated in the community. CONCLUSIONS: The most important aspect of patient care is safety, and this should not be compromised if, for example, postoperative review were to be moved to primary care. As expected, this study shows that patients will self-present if they have problems postoperatively.

A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study.

INTRODUCTION AND HYPOTHESIS: This prospective multi-centre true two-sided equivalence trial was designed to test the clinical equivalence of open (ASCP) and laparoscopic (LSCP) sacrocolpopexy using objective and subjective outcomes METHODS: The study was carried out in three urogynaecology units in England, UK and the patient population consisted of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions were either abdominal or laparoscopic sacrocolpopexy following randomisation to one of the types of surgery. RESULTS: For the primary outcome (point C on the POP-Q) the results at 1 year were -6.63 cm for the open ASCP and -6.67 cm for the LSCP respectively. Subjective outcomes at 1 year showed that 90% of the ASCP group and 80% of the LSCP group were "much better". There were improvements with regard to blood loss, haemoglobin and shorter length of stay in the LSCP group compared with the ASCP group. CONCLUSION: This fully powered randomised controlled trial comparing open and laparoscopic sacrocolpopexy has shown clinical equivalence.

Do we really know the outcomes of prolapse surgery?

The exact success rate from conventional as well as new surgical procedures for pelvic organ prolapse is unknown possibly due to the lack of standardisation of outcome measures. Usually objective measures, e.g. Pelvic Organ Prolapse Quantification (POPQ) assessment have been used as the primary outcome in most studies which show that procedures such as anterior repair have a poor outcome. However these outcomes correlate poorly with subjective assessment and re-operation rates are lower than the anatomical failure rate suggesting that conventional surgery might not have as poor an outcome as previously suggested. Nonetheless, new procedures have been introduced for which efficacy and safety data are required via well conducted randomised controlled trials.

The long-term effectiveness of antenatal pelvic floor muscle training: eight-year follow up of a randomised controlled trial.

OBJECTIVE: To determine the long-term effectiveness of antenatal pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI). DESIGN: Eight-year follow up of a randomised controlled trial (RCT). SETTING: Acute NHS Teaching Trust. POPULATION: Participants in an RCT of antenatal PFMT 8 years previously. METHOD: Participants were asked about the presence of SUI, impact on quality of life, frequency of performance of PFMT and details of subsequent deliveries. MAIN OUTCOME MEASURE: The prevalence of SUI at 8 years. RESULTS: One hundred and sixty-four (71%) of the original 230 women responded. The significant improvement in postnatal SUI originally shown in the PFMT group compared with controls (19.2 versus 32.7%, P = 0.02) at 3 months was not evident 8 years later (35.4 versus 38.8%, P = 0.7). On direct questioning, 68.4% of the study group claimed that they still performed PFMT as taught during the study, with 38.0% of them performing this twice or more per week. There was no difference in outcome between those who performed PFMT twice or more per week compared with those performing PFMT less frequently. There were no differences in quality-of-life domains between the study and the control groups at 8 years. CONCLUSION: The initially beneficial effect of supervised antenatal PFMT on SUI did not continue for a long term despite the majority claiming to still perform PFMT. These findings are in keeping with those of other studies and raise concerns about the long-term efficacy of PFMT. Strategies to improve compliance with PFMT are required.

cDNA sequences for transcription factors and signaling proteins of the hemichordate Saccoglossus kowalevskii: efficacy of the expressed sequence tag (EST) approach for evolutionary and developmental studies of a new organism.

We describe a collection of expressed sequence tags (ESTs) for Saccoglossus kowalevskii, a direct-developing hemichordate valuable for evolutionary comparisons with chordates. The 202,175 ESTs represent 163,633 arrayed clones carrying cDNAs prepared from embryonic libraries, and they assemble into 13,677 continuous sequences (contigs), leaving 10,896 singletons (excluding mitochondrial sequences). Of the contigs, 53% had significant matches when BLAST was used to query the NCBI databases (< or = 10(-10)), as did 51% of the singletons. Contigs most frequently matched sequences from amphioxus (29%), chordates (67%), and deuterostomes (87%). From the clone array, we isolated 400 full-length sequences for transcription factors and signaling proteins of use for evolutionary and developmental studies. The set includes sequences for fox, pax, tbx, hox, and other homeobox-containing factors, and for ligands and receptors of the TGFbeta, Wnt, Hh, Delta/Notch, and RTK pathways. At least 80% of key sequences have been obtained, when judged against gene lists of model organisms. The median length of these cDNAs is 2.3 kb, including 1.05 kb of 3' untranslated region (UTR). Only 30% are entirely matched by single contigs assembled from ESTs. We conclude that an EST collection based on 150,000 clones is a rich source of sequences for molecular developmental work, and that the EST approach is an efficient way to initiate comparative studies of a new organism.

The effect of cannabis on urge incontinence in patients with multiple sclerosis: a multicentre, randomised placebo-controlled trial (CAMS-LUTS).

OBJECTIVE: To test whether cannabinoids reduce urge incontinence episodes without affecting voiding in patients with multiple sclerosis. This was part of the multicentre trial of the Cannabinoids in Multiple Sclerosis (CAMS) study. SUBJECTS AND METHODS: The CAMS study randomised 630 patients to receive oral administration of cannabis extract, Delta(9)-tetrahydrocannabinol (THC) or matched placebo. For this substudy subjects completed incontinence diaries. RESULTS: All three groups showed a significant reduction, p<0.01, in adjusted episode rate (i.e. correcting for baseline imbalance) from baseline to the end of treatment: cannabis extract, 38%; THC, 33%; and placebo, 18%. Both active treatments showed significant effects over placebo (cannabis extract, p=0.005; THC, p=0.039). CONCLUSION: The findings are suggestive of a clinical effect of cannabis on incontinence episodes in patients with MS. This is in contrast to the negative finding of the CAMS study, where no difference was seen in the primary outcome of spasticity.

Initial management of stress urinary incontinence: pelvic floor muscle training and duloxetine.

Stress urinary incontinence (SUI) is common among women of all ages and can have a negative impact on quality of life (QoL). Often, women refrain from seeking treatment due to the fear that surgery might be the only option, or that no other treatments exist. SUI symptoms can often be treated with simple measures such as pelvic floor muscle training (PFMT), weight loss, devices, etc. However, PFMT has low compliance rates, and few continue long term. More recently, another treatment option has been introduced, i.e. the relatively balanced serotonin and noradrenaline reuptake inhibitor (SNRI) duloxetine. PFMT and/or SNRI are recommended as a first-line therapy for the initial management of SUI in women in the guidelines of the third International Consultation on Incontinence. SNRI have received a grade A recommendation. As PFMT and duloxetine target different areas (i.e. pelvic floor muscle and distal urethral sphincter/rhabdosphincter, respectively), combined therapy might provide additional benefit. A recent study comparing the effect of combined treatment with no active treatment found that combination therapy was significantly better for all outcomes, including frequency of SUI episodes, pad use, improvements in QoL and global impression of improvement scores. The data suggest that combination therapy might provide another treatment option for SUI symptoms in women.

Overactive bladder.

The overactive bladder is a common condition, which has significant effects on quality of life. The aetiology in most cases is unknown, and treatment outcomes have until recently been unsatisfactory. Management includes excluding pathology and implementing behavioural changes such as caffeine reduction, bladder and pelvic floor training, as well as antimuscarinic drug therapy. Compliance is often problematic, and this can be improved with some of the newer antimuscarinics with fewer side-effects, and a good therapist/patient relationship. In the majority of cases this 'treatment package' is successful, but in those where it is not, intravesical therapies have been introduced, e.g. neuromodulation, alternative drug therapies (e.g. vanilloids, botox) and surgery. With a better understanding of the aetiology and identification of risk factors better outcomes from treatment are likely.