Robot-assisted surgery for the management of apical prolapse: a bi-centre prospective cohort study.

OBJECTIVE: Robot-assisted surgery is a recognised treatment for pelvic-organ prolapse. Many of the surgical subgroup outcomes for apical prolapse are reported together, leading to a paucity of homogenous data. DESIGN: Prospective observational cohort study (NCT01598467, clinicaltrials.gov) assessing outcomes for homogeneous subgroups of robot-assisted apical prolapse surgery. SETTING: Two European tertiary referral hospitals. POPULATION: Consecutive patients undergoing robot-assisted sacrocolpopexy (RASC) and supracervical hysterectomy with sacrocervicopexy (RSHS). METHODS: Anatomical cure (simplified Pelvic Organ Prolapse Quantification, sPOPQ, stage 1), subjective cure (symptoms of bulge), and quality of life (Pelvic Floor Impact Questionnaire, PFIQ-7). MAIN OUTCOME MEASURES: Primary outcome: anatomical and subjective cure. SECONDARY OUTCOMES: surgical safety and intraoperative variables. RESULTS: A total of 305 patients were included (RASC n = 188; RSHS n = 117). Twelve months follow-up was available for 144 (RASC 76.6%) and 109 (RSHS 93.2%) women. Anatomical success of the apical compartment occurred for 91% (RASC) and in 99% (RSHS) of the women. In all compartments, the success percentages were 67 and 65%, respectively. Most recurrences were in the anterior compartment [15.7% RASC (symptomatic 12.1%); 22.9% RSHS (symptomatic 4.8%)]. Symptoms of bulge improved from 97.4 to 17.4% (P < 0.0005). PFIQ-7 scores improved from 76.7 ± 62.3 to 13.5 ± 31.1 (P < 0.0005). The duration of surgery increased significantly for RSHS [183.1 ± 38.2 versus 145.3 ± 29.8 (P < 0.0005)]. Intraoperative complications and conversion rates were low (RASC, 5.3 and 4.3%; RSHS, 0.0 and 0.0%). Four severe postoperative complications occurred after RASC (2.1%) and one occurred after RSHS (1.6%). CONCLUSIONS: This is the largest reported prospective cohort study on robot-assisted apical prolapse surgery. Both procedures are safe, with durable results. TWEETABLE ABSTRACT: European bi-centre trial concludes that robot-assisted surgery is a viable approach to managing apical prolapse.

Da Vinci robot emergency undocking protocol.

The role of robot-assisted surgery across gynaecology is evolving with increasing numbers of procedures being undertaken with varying degrees of complexity. While the risk of conversion is low at approximately 1 %, the reasons for conversion are variable. These range from technical issues with the robot, surgical complications such as haemorrhage and anaesthetics issues such as an inability to ventilate the patient adequately. While many conversions to open or laparoscopic approach are not due to life-threatening indications, it is important that the theatre staff are aware of the indication and can perform an emergency undocking as effectively, efficiently and safely as possible when the need arises. Unfortunately, there is a paucity of the literature available outlining such protocols. For this reason, we developed an emergency undocking protocol clearly outlining the role of each theatre staff member and the need for clear concise communication.

The Effect of Bariatric Surgery on Urinary Incontinence in Women.

BACKGROUND: Little is known regarding the effect of bariatric surgery on urinary incontinence. METHODS: Between September 2008 and November 2014, 240 female patients underwent bariatric surgery. RESULTS: The prevalence of urinary incontinence preoperatively was 45 % (108). Eighty-two (76 %) completed urinary function questionnaires pre-operatively and post-operatively. Fifty-seven (70 %) underwent laparoscopic gastric bypass, twenty-four (29 %) underwent sleeve gastrectomy and one underwent a banding procedure. Thirty-one (38 %) reported leaking on sneezing or coughing-stress urinary incontinence (SUI). Thirteen (16 %) complained of leaking before reaching the toilet-overactive bladder syndrome (OAB). The remaining thirty-eight (46 %) reported mixed symptoms. The mean pre-operative weight and BMI were 133 (18) kg and 50 (SD = 6.2) kg/m(2) respectively. The mean post-operative BMI drop was 16 (SD = 5.2) kg/m(2). Preoperatively, 61 (75 %) reported moderate to very severe urinary incontinence compared to 30 (37 %) post-operatively (χ (2) = 3.24.67, p = 0.050). Twenty-seven (33 %) patients reported complete resolution of their urinary incontinence. Fifty-one (62 %) patients required incontinence pads on a daily basis pre-operatively, compared to 35 (43 %) post-operatively (χ (2) = 22.211.6, p = 0.00). The mean International Consultation on Incontinence Questionnaire- Urinary Incontinence short form (ICIQ-UI SF) score was 9.3 (SD = 4.4) pre-operatively compared to 4.9 (SD = 5.3) post-operatively (t = 7.2, p = 0.000). The improvement score post-operatively was 8 (SD = 3). A significant difference in the ICIQ-UI SF was identified between OAB and SUI groups when adjusting for age, number of children, type of delivery and pre-op BMI (t = 1.98, p = 0.05). CONCLUSION: Bariatric surgery results in a clinically significant improvement in urinary incontinence. However, this is not proportional to pre-operative BMI, weight loss, age, parity and mode of delivery.

Status of the pelvic floor in young primiparous women.

OBJECTIVES: To investigate the postnatal prevalence of sonographically diagnosed pelvic floor trauma, and the correlations with various antenatal/intrapartum predictors in primiparous women. METHODS: This was a prospective cohort study performed in a tertiary hospital with 9000 deliveries per annum. Of those invited, 202 (23.2%) primiparous participants were assessed clinically at least 1 year after delivery by Pelvic Organ Prolapse Quantification (POP-Q), two/three-dimensional transperineal sonography and quantification of serum collagen type III levels. RESULTS: There was a high prevalence of clinically significant pelvic organ prolapse (POP) on POP-Q staging: uterine prolapse, 63%; cystocele, 42%; and rectocele, 23%. Ballooning of the levator ani muscle (LAM) hiatus was detected in 33% and LAM avulsion in 29% of participants, with partial LAM avulsion occurring in 15% and complete avulsion in 14%. Postnatal POP symptoms (odds ratios (ORs) given here for presence of multiple prolapse symptoms) were positively associated with similar prepregnancy symptoms (OR, 7.2 (95% CI, 1.19-44.33)), LAM avulsion (OR, 4.8 (95% CI, 1.99-11.34)) and forceps delivery (borderline significance; OR, 1.8 (95% CI, 0.96-3.25)) and negatively associated with elective (OR, 0.2 (95% CI, 0.09-0.63)) and emergency (OR, 0.3 (95% CI, 0.12-0.83)) Cesarean section. LAM abnormality was associated with forceps delivery (OR, 4.9 (95% CI, 1.44-16.97)) and prolapse (OR, 6.8-11.7 (95% CI, 2.34-78.51)), whereas collagen levels did not play a role (OR, 1.001 (95% CI, 0.99-1.02)). CONCLUSIONS: Clinically significant POP was common in relatively young premenopausal primiparous women. Partial or full levator avulsion was seen in 29% of participants and was associated with POP and related symptoms. Congenital factors seem to play little role in the etiology of LAM trauma, and the main risk factor seems to be forceps delivery. Avoidance of difficult vaginal deliveries may prevent severe pelvic floor trauma.

The role of prepregnancy pelvic floor dysfunction in postnatal pelvic morbidity in primiparous women.

INTRODUCTION AND HYPOTHESIS: Little is known about the natural history of pelvic floor dysfunction (PFD). We investigated the association between prepregnancy and postnatal PFD in premenopausal primiparous women and the associated effect of mode of delivery. METHODS: A prospective cohort study, nested within the parent Screening for Pregnancy Endpoints (SCOPE) study, was performed in a tertiary referral teaching hospital with approximately 9,000 deliveries per annum. The validated Australian pelvic floor questionnaire was completed by 872 nulliparous women at 15 weeks' gestation, at the time of recruitment to the SCOPE study and 1 year postnatally. The questionnaire contained four sections with questions about urinary, faecal, prolapse and sexual dysfunction. RESULTS: One year postnatally urinary dysfunction was present in 73%, faecal in 49%, prolapse in 14% and sexual in 58% of participants. Prepregnancy PFD persistent postnatally constituted more than half of total PFD. The majority of affected (71%) had multicompartment involvement. Participants with persistent PFD had higher prevalence of severe symptoms and bothersome symptoms within the group. Severity of prepregnancy PFD worsened in <15% cases postnatally. CONCLUSIONS: The main damage to the pelvic floor seems to occur in the majority of patients before first pregnancy, where first childbearing does not worsen prepregnancy PFD in the majority of cases. Pregnancy appears to affect more pre-existing symptoms of urgency and urge incontinence comparing to stress incontinence. Caesarean section seems to be more protective against postnatal worsening of prepregnancy PFD comparing to de novo onset pathology. However, larger studies are needed to confirm these findings.

Prevalence, etiology and risk factors of pelvic organ prolapse in premenopausal primiparous women.

INTRODUCTION: The natural history of pelvic organ prolapse (POP) is poorly understood. We investigated the prevalence and risk factors of postnatal POP in premenopausal primiparous women and the associated effect of mode of delivery. METHODS: We conducted a prospective cohort study in a tertiary teaching hospital attending 9,000 deliveries annually. Collagen-diseases history and clinical assessment was performed in 202 primiparae at ≥ 1 year postnatally. Assessment included Pelvic Organ Prolapse Quantification (POP-Q) system, Beighton mobility score, 2/3D-transperineal ultrasound (US) and quantification of collagen type III levels. Association with POP was assessed using various statistical tests, including logistic regression, where results with p < 0.1 in univariate analysis were included in multivariate analysis. RESULTS: POP had a high prevalence: uterine prolapse 89 %, cystocele 90 %, rectocele 70 % and up to 65 % having grade two on POP-Q staging. The majority had multicompartment involvement, and 80 % were asymptomatic. POP was significantly associated with joint hypermobility, vertebral hernia, varicose veins, asthma and high collagen type III levels (p < 0.05). In multivariate logistic regression, only levator ani muscle (LAM) avulsion was significant in selected cases (p < 0.05). Caesarean section (CS) was significantly protective against cystocele and rectocele but not for uterine prolapse. CONCLUSIONS: Mild to moderate POP has a very high prevalence in premenopausal primiparous women. There is a significant association between POP, collagen levels, history of collagen disease and childbirth-related pelvic floor trauma. These findings support a congenital contribution to POP etiology, especially for uterine prolapse; however, pelvic trauma seems to play paramount role. CS is significantly protective against some types of prolapse only.

An insight into pelvic floor status in nulliparous women.

INTRODUCTION AND HYPOTHESIS: Few studies have comprehensively investigated the prevalence of various types of pelvic floor Dysfunction (PFD) in women before their first pregnancy. However, no previous studies have investigated in detail all four compartments of PFD and the correlation between them. METHODS: This was a cross-sectional study nested within a parent prospective study Screening for Pregnancy Endpoints (SCOPE) performed in a tertiary referral teaching hospital with approximately 9,000 deliveries per annum. Nulliparous women completed the validated Australian Pelvic Floor Questionnaire at 15 weeks' gestation, at the time of recruitment to the SCOPE study. The questionnaire contained four sections, with questions about urinary, faecal, prolapse and sexual dysfunction in the prepregnancy period. RESULTS: A total of 1,484 participants completed the prenatal questionnaire. Urinary dysfunction was present in 61 % of participants, faecal in 41 %, prolapse in 5 % and sexual in 41 %; in 37 %, dysfunction was perceived as bothersome . At least one clinically significant symptom, defined as severity grade 2 or 3, or grade 1 associated with being bothersome, was reported by 58.2 % of participants. More than one type of PFD was present in 57.6 % of cases. The severity score of each symptom within a PFD section was associated with total section score. CONCLUSIONS: We confirmed a high rate of PFD in nulliparous women. Clinically significant symptoms and associated bother were very common among symptomatic participants. The majority of affected women had more than one type of PFD. Postnatal follow-up is needed in order to elucidate the role of prepregnancy symptoms in the aetiology of postnatal pelvic floor pathology.

Lightweight meshes: evaluation of mesh tissue integration and host tissue response.

INTRODUCTION: Differences in mesh composition may affect outcomes such as erosion, tissue integration and inflammation. The majority of commercially available meshes are type 1, manufactured from monofilament polypropylene with differing pore sizes and mechanical properties. OBJECTIVE: To assess the local tolerance of four commercially available meshes in terms of mesh integration and host tissue response. METHOD: Using an animal model, mesh was implanted onto the abdominal sheath. Animals were sacrificed at 7, 30 and 90 days and data collected. RESULTS: Strength of mesh-skin integration increased in all groups across the three time points. Polyform displayed highest strength of separation overall. VM PFR and Iprolite reached their maximum integration earliest. In regard to mesh abdominal wall integration Polyform had the greatest strength of separation, with Ultrapro displaying some weakening of integration at 30 and 90 days. Host tissue response was similar in all groups at each time point. CONCLUSION: Polyform and VM PFR have enhanced tissue integration when compared to Ultrapro. This decreased integration in Ultrapro may lead to increased mesh failure. The composition of mesh affects its integration and potentially its failure rate but not host tissue response. These observations in mesh characteristics may benefit the design of next generation meshes with a view to reducing failure rates and erosion.

Interstitial cystitis/bladder pain syndrome: diagnosis and management.

INTRODUCTION AND HYPOTHESIS: The bladder pain syndrome (BPS) is a spectrum of urological symptoms characterised by bladder pain with typical cystoscopic features. Diagnosis and management of this syndrome may be difficult. There is no evidence-based management approach for the diagnosis or treatment of BPS. The objective of this study was to critically review and summarise the evidence relating to the diagnosis and treatment of the bladder pain syndrome. METHODS: A review of published data on the diagnosis and treatment of the BPS was performed. Our search was limited to English-language articles, on the "diagnosis", and "management" or "treatment" of "interstitial cystitis" and the "bladder pain syndrome" in "humans." RESULTS: Frequency, urgency and pain on bladder filling are the most common symptoms of BPS. All urodynamic volumes are reduced in patients with BPS. Associated conditions include psychological distress, depression, history of sexual assault, irritable bowel syndrome and fibromyalgia. Cystoscopy remains the test for definitive diagnosis, with visualisation of haemorrhage on cystoreduction. A multidisciplinary treatment approach is essential in the management of this condition. Orally administered amitriptyline is an efficacious medical treatment for BPS. Intravesical hyaluronic acid and local anaesthetic, with/without hydrodistension are among new treatment strategies. Sacral or pudendal neuromodulation is effective, minimally invasive and safe. Surgery is reserved for refractory cases. CONCLUSIONS: There remains a paucity of evidence for the diagnosis and treatment of BPS. We encountered significant heterogeneity in the assessment of symptoms, duration of treatment and follow up of patients in our literature review.

Robot-assisted surgery:--impact on gynaecological and pelvic floor reconstructive surgery.

The da Vinci Surgical System dominates robotic surgery, as the only robotic device to have FDA approval in gynaecology. The benefits of robot-assisted surgery include decreased length of stay, decreased blood loss and analgesic requirements. Ergonomic improvements allow the surgeon to operate with less risk of neck and back injury. Unfortunately the initial economic impact of purchasing and maintaining a robot are great but must be balanced with the potential savings from reduced length of stay and earlier return to normal activity. This review looks at the uses for the robot in both gynaecology and urogynaecology, assessing the efficacy of this modality compared to both straight stick (laparoscopy) and open procedures. We assess the benefits to both patient and surgeon from the available literature. Within the current economic environment we appraise the costs associated with the robot.

A prospective randomised double-blind controlled trial evaluating the effect of trans-sacral magnetic stimulation in women with overactive bladder.

Overactive bladder (OAB) is a prevalent condition with 16% of adults having one or more symptoms that significantly affect quality of life. Transcutaneous electrical nerve stimulation and neuromodulators have had success in treating OAB but are expensive, invasive, and sometimes cumbersome. We developed an alternative neuromodulatory technique that involves electromagnetic stimulation of the sacral nerve roots with a portable electromagnetic device to produce trans-sacral stimulation of the S3 and S4 sacral nerve roots. The aim of this study was to evaluate the impact of this device on OAB symptoms in women with a prospectively randomised double-blind controlled study. Following a power analysis, women with symptoms of OAB were prospectively recruited with ethical approval for randomisation to an active treatment (n = 33) or placebo group (n = 30) in a double-blind trial. The patient, at home, used the belt device daily for 20 min over 12 weeks. Outcome measures included a 3-day voiding diary, 1 h pad test, visual analogue score (VAS) for symptom impact (0-100%), Kings Health Questionnaire (KHQ) and Australian Quality of Life questionnaire (AQOL) at baseline, 6 and 12 weeks. Overall, no difference was found between groups for any of the research questions. Specifically, we were unable to demonstrate any difference between the active and sham device groups in frequency, nocturia, urinary leakage, or quality of life, nor was there any evidence of a placebo effect. The quality of the data was high with the number of missing observations (especially for disease specific KHQ and general AQOL) being few. This attempt to promote trans-sacral electromagnetic neuromodulation with a specially created device was ineffective on the symptoms of OAB.

Transdermal posterior tibial nerve laser therapy is not effective in women with interstitial cystitis.

PURPOSE: Interstitial cystitis (IC) is a debilitating condition which causes irritative bladder symptoms, pain and a decrease in health status. The pathophysiology is poorly understood so therapeutic options are diverse. Percutaneous posterior tibial nerve stimulation is an effective treatment and pulsed transdermal laser stimulation is an established technique for pain management. We evaluated the efficacy of transdermal laser stimulation of the posterior tibial nerve for patients with IC. MATERIALS AND METHODS: Women meeting the National Institutes of Health National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC were prospectively recruited and randomized to treatment (29) or placebo (27) cohorts in a double-blind trial. At home the patient performed laser therapy daily for 30 seconds over the SP6 acupuncture point for 12 weeks. Measures at baseline and at 84-day followup included the 7-day voiding diary, the Interstitial Cystitis Problem Index, Interstitial Cystitis Symptom Index and RAND 36-Item Health Survey questionnaires. RESULTS: There were no significant differences between the treatment and control cohorts on any of the measures. However, there was a significant decrease between baseline and 12-week followup in the amount voided, symptom problems and severity, and on all 8 SF-36 scales. There was no significant effect of fluid intake. CONCLUSIONS: This study demonstrated no difference between the active and sham device. However, it is interesting that treatment and control cohorts experienced similar improvements, suggesting that the control cohort improvements may have been due to participants' belief that they were receiving active treatment from the stimulator. These findings provide support for investigating placebo effects in randomized trials.

A quantitative analysis of purinoceptor expression in human fetal and adult bladders.

PURPOSE: In adults there is evidence that adenosine triphosphate acting at P2X receptors functions as a co-transmitter at vesical smooth muscle. The contractile mechanisms of human fetal bladder have been studied to a limited extent and it remains undetermined whether P2X receptors contribute. We compared the expression of the 7 known P2X receptors in fetal and adult human bladders using a quantitative polymerase chain reaction (PCR) based method. MATERIALS AND METHODS: Real-time quantitative reverse transcriptase-PCR provides a system for the detection and analysis of RNA. Four complete cadaver fetal bladders were obtained at 16 weeks to full-term gestation and divided into a total of 12 segments. Adult bladder samples were obtained from 4 patients requiring bladder biopsy. Total RNA was extracted from each sample and 10 ng. were used for individual PCR reactions. An ABI 7700 machine (PE Applied Biosystems, California) determined expression levels of the 7 P2X genes in total RNA. RESULTS: In adult bladders P2X1 was by far the predominant purinergic receptor at the messenger RNA level. The remaining purinergic receptors were consistently present in the order P2X1 >> P2X4 > P2X7 >> P2X5 > P2X2 >> P2X3 = P2X6 = 0. In fetal bladders the expression of P2X1 transcripts was much lower than in adult bladders, and P2X4 and P2X7 were also present. The rank order of the P2X transcript level was P2X1 = P2X4 > P2X7 >> P2X5 >> P2X2 >> P2X3 = P2X6 = 0. With increasing gestation the P2X receptor transcript level (expression) shifted from the dome to the body of the bladder. CONCLUSIONS: P2X1 is the predominant purinoceptor subtype in adult human bladders, consistent with pharmacological evidence. The fetal expression of all P2X receptor transcripts is much lower than in adults, suggesting that purinergic transmission is of less importance. However, there are also several marked developmental changes in purinoceptor expression in the bladder, in that P2X4 is expressed in developing bladders at relatively high levels. There is also a marked developmental change in the regional distribution of purinoceptors. These changes are likely to reflect the changing role of purinergic transmission in the control of bladder motility during fetal maturation.

A quantitative analysis of purinoceptor expression in the bladders of patients with symptomatic outlet obstruction.

OBJECTIVE: To compare the expression of the seven known P2X receptors in human bladder from male patients with detrusor instability caused by symptomatic bladder outlet obstruction with that from control bladders, using a quantitative reverse transcription-polymerase chain reaction (RT-PCR) method. PATIENTS AND METHODS: Real-time quantitative RT-PCR provides a system for detecting and analysing RNA. Bladder biopsies were obtained from nine patients undergoing prostate surgery and control biopsies were obtained from eight age-matched men undergoing routine bladder endoscopy studies, and who were asymptomatic. Total RNA was extracted from each sample and 10 ng of this used for individual PCR reactions. The expression levels of the seven P2X genes in the total RNA were then determined. RESULTS: In the control bladder, P2X1 was by far the predominant purinergic receptor at the RNA level, the remainder consistently present in the order P2X1 >> P2X4 > P2X2 > P2X7 > P2X5 >> P2X3 = P2X6 = 0. Calponin, a smooth muscle-specific protein, was used as a marker for smooth muscle content. In bladder from symptomatic patients, the P2X1/calponin ratio was greater than that in controls (P = 0.016). There appeared to be no difference in P2X2, but P2X4, P2X5, and P2X7 were all greater in the symptomatic bladder than in the controls, although these differences were not significant. CONCLUSION: P2X1 is the predominant purinoceptor subtype in the human male bladder, consistent with pharmacological evidence. The amount of P2X1 receptor per smooth muscle cell is greater in the obstructed than in control bladder, suggesting an increase in purinergic function in the unstable bladder arising from bladder outlet obstruction.

Formulation of a defined medium to maintain cell health and viability in vitro.

The first step in formulating a defined medium is to conduct a thorough search of the scientific literature. If a defined medium formulation is located that might be compatible with the intended cell system, a pilot study should be carried out to evaluate the general performance of the medium. Depending on the initial data obtained from this study, individual components of the medium and their concentrations may need to be manipulated (added/subtracted, increased/decreased) to obtain the desired results. Also, sometimes the basal medium or proportions of basal media must be changed. Because the formulation of a defined medium is a circular process, alteration of the basal medium type or ratio of basal media will necessitate redoing all of the previous addition/subtraction and optimization steps. Revalidation must also be done if vendors of components are changed or whenever different cells or cells of other ages are used in the system. This paper presents a brief procedure for formulating a defined media and an overview of the application of two defined media in muscle cell culture.