Autologous Fascial Slings for Stress Urinary Incontinence: a 17-year Follow-up of a Randomised Controlled Study.

INTRODUCTION AND HYPOTHESIS: Safety concerns with the use of mesh in vaginal surgery have been ongoing. Autologous fascial slings (AFS) avoid foreign body complications. We compared the long-term (17-year) outcomes of two AFS repair methods-the standard sling and short sling (sling-on-string), and assessed durability and patient satisfaction of these for the treatment of stress urinary incontinence (SUI). METHODS: A total of 107 patients from three urogynaecology units who had participated in a randomised controlled trial assessing standard (n = 52) and short (n = 55) slings were followed up for a median period of 17 years. Primary outcomes were Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores to assess the impact on the quality of life and symptom distress. Logistic quantile regression was employed to compare the two methods. Secondary outcomes included long-term complications and patient satisfaction. RESULTS: Mean scores showed no statistically significant difference between the standard and short slings at the 17-year follow-up relating to IIQ and UDI scores, leakage or urgency (p > 0.05). Improved bladder function was observed at 17 years compared with baseline (standard sling-IIQ scores mean difference [MD] 1.22 [CI: 0.69, 1.74], UDI scores MD 0.83 [CI: 0.70, 0.97]; short sling-IIQ score MD 1.14 [CI: 0.73, 1.54], UDI scores MD 0.54 [CI: 0.40, 0.67]) with age-related deterioration over time. Re-operation rates were low and patient satisfaction rates were high (67.2%) at follow-up. CONCLUSIONS: Autologous fascial slings are an effective and durable option for management of SUI and the short sling procedure can be recommended owing to plausible surgical advantages.

Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity.

AIMS: To assess the efficacy and morbidity of alkalinized lidocaine solution compared to lidocaine gel for intra-vesical anesthesia during botulinum toxin (BoNTA) injections in a statistically powered, prospective, parallel group, double-blind randomized controlled trial. METHODS: Fifty-four patients of either sex were randomized to receive either alkalinized lidocaine (AL) solution (10 ml 8.4% sodium bicarbonate + 20 ml 2% lidocaine solution + 22 ml sterile Aquagel®) or lidocaine gel (LG) (22 ml standard 2% lidocaine gel Instillagel® + 30 ml 0.9% normal saline solution). Primary outcome was average pain (assessed by 100 mm visual analog score) felt during intra-vesical BoNTA injections performed at least 20 min after instillation. Secondary outcome was the rate of adverse events. RESULTS: Of 60 randomized patients 54 received the allocated intervention and were analyzed. Mean pain score in the AL group was 17.11 mm (95%CI 8.65-25.57 mm) and in the LG group was 19.53 mm (95%CI 13.03-26.03mm) with no significant difference between the groups. Cost of interventional medication in the AL group was almost double that of the LG group. No adverse events were attributable to local anesthetic instillation in either group. CONCLUSIONS: Alkalinized lidocaine solution is not superior to lidocaine gel for anesthesia during intra-vesical BoNTA injections, and the higher cost precludes its use over lidocaine gel at our centre. We have used the results of this study to adapt our local protocol for BoNTA injections and continue to use lidocaine gel as the local anesthetic of choice. Neurourol. Urodynam. 35:522-527, 2016. © 2015 Wiley Periodicals, Inc.

Influence of antenatal physical exercise on haemodynamics in pregnant women: a flexible randomisation approach.

BACKGROUND: Normal pregnancy is associated with marked changes in haemodynamic function, however the influence and potential benefits of antenatal physical exercise at different stages of pregnancy and postpartum remain unclear. The aim of this study was therefore to characterise the influence of regular physical exercise on haemodynamic variables at different stages of pregnancy and also in the postpartum period. METHODS: Fifty healthy pregnant women were recruited and randomly assigned (2 × 2 × 2 design) to a land or water-based exercise group or a control group. Exercising groups attended weekly classes from the 20th week of pregnancy onwards. Haemodynamic assessments (heart rate, cardiac output, stroke volume, total peripheral resistance, systolic and diastolic blood pressure and end diastolic index) were performed using the Task Force haemodynamic monitor at 12-16, 26-28, 34-36 and 12 weeks following birth, during a protocol including postural manoeurvres (supine and standing) and light exercise. RESULTS: In response to an acute bout of exercise in the postpartum period, stroke volume and end diastolic index were greater in the exercise group than the non-exercising control group (p = 0.041 and p = 0.028 respectively). Total peripheral resistance and diastolic blood pressure were also lower (p = 0.015 and p = 0.007, respectively) in the exercise group. Diastolic blood pressure was lower in the exercise group during the second trimester (p = 0.030). CONCLUSIONS: Antenatal exercise does not appear to substantially alter maternal physiology with advancing gestation, speculating that the already vast changes in maternal physiology mask the influences of antenatal exercise, however it does appear to result in an improvement in a woman's haemodynamic function (enhanced ventricular ejection performance and reduced blood pressure) following the end of pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02503995. Registered 20 July 2015.

Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women.

OBJECTIVE: To compare the long-term outcomes of a tension-free vaginal tape (TVT; Gynecare™, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol™; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI). PATIENTS AND METHODS: A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol. The primary outcome was surgical success defined as 'women reporting being completely 'dry' or 'improved' at the time of follow-up'. The secondary outcomes included 'completely dry' rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL EQ-5D questionnaire scores. RESULTS: In all, 162 (80.6%) women were available for follow-up with a median (range) duration of 10 (6.6-12.6) years. 'Success' rates for TVT, AFS and Pelvicol were 73%, 75.4% and 58%, respectively. Comparing the 1- and 10-year 'success' rates, there was deterioration from 93% to 73% (P < 0.05) in the TVT arm and 90% to 75.4% (P < 0.05) in the AFS arm; 'dry' rates were 31.7%, 50.8% and 15.7%, respectively. Overall, the 'dry' rates favoured AFS when compared with Pelvicol (P < 0.001) and TVT (P = 0.036). The re-operation rate for persistent SUI was 3.2% (two patients) in the TVT arm, 13.1% (five) in the Pelvicol arm, while none of the patients in the AFS arm required further intervention. CONCLUSIONS: Our study indicates there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However, there is some evidence that 'dry' rates for AFS may be more durable than TVT.

Outcomes and complications of trans-vaginal mesh repair using the Prolift™ kit for pelvic organ prolapse at 4 years median follow-up in a tertiary referral centre.

PURPOSE: To evaluate the anatomical, functional and post-operative outcomes of polypropylene mesh (Prolift™) in the surgical management of pelvic organ prolapse (POP). METHODS: A single-centre observational study of 106 successive patients, who underwent Prolift™ mesh repair (POP ≥ 2) with a median follow-up of 4 years, was performed. Outcomes of interest measured included patient demographics, intra and post-operative complications, concomitant procedures for POP or urinary incontinence. Using the Baden-Walker classification, grade ≥2 prolapses in the operated compartment were deemed as surgical failure. Validated questionnaires including ICIQ-VS and ICIQ-UI were used to assess functional outcome. RESULTS: Of the 106 patients, 56 had an anterior, 36 a posterior and 14 a total Prolift™. 101 patients were available for follow-up (median 4 years). 82 women underwent a clinical follow-up whilst 19 underwent a telephonic follow-up. Peri-operative bladder injury was noted in 2 (1.9 %) cases. Six (5.6 %) patients developed mesh exposure post-operatively. Re-operation rates for recurrent prolapse in the operated compartment were 2.8 % (n = 3). At follow-up, prolapse recurrence in the operated compartment was noted in another 7.3 % (n = 6) patients. Combining re-operations for POP and recurrences noted during follow-up, the revised failure rate was 10.1 % (n = 9). De novo prolapse in the non-operated compartment occurred in 19.5 % (n = 16) women. CONCLUSION: Our study demonstrates that Prolift™ vaginal mesh surgery offers anatomical cure rates of 89.9 %. A higher rate of de novo recurrence in the non-operated compartment was noted suggesting that surgical correction in one compartment may exacerbate recurrence in other compartments.

Influence of somatic state on cardiovascular measurements in pregnancy.

Normal pregnancy causes marked changes in cardiac and haemodynamic function but there is continuing debate about the patterns of 'normal' change. We believe that this lack of consensus is in large part caused by inappropriate assessment conditions. This study aimed to assess physiological data obtained from pregnant women during multiple steady-states and during between-state changes. The study was a longitudinal characterization of apparently healthy pregnant women aged >18 years with assessments at three antenatal stages (12-16, 26-28 and 34-36 weeks) and at 12 weeks following birth. Cardiovascular and heart rate variability (HRV) measures were quantified non-invasively during a range of states including postural manoeuvre, exercise and respiratory regulation. Cardiovascular and HRV variables were influenced by pregnancy in specific ways: (1) steady-state values were influenced differently to state-change responses; (2) cardiac output (CO) increased progressively throughout pregnancy in all states except supine rest; (3) the ΔCO response to the supine-standing manoeuvre was particularly sensitive to pregnancy stage; (4) blood pressure was unaffected by pregnancy; (6) ΔCO and ΔSBP (systolic blood pressure) were enhanced from mid-pregnancy onwards; (7) ΔHRV responses to state changes were markedly and progressively influenced by pregnancy. This study indicates that cardiovascular function in pregnant women is best quantified during at least one physical state change (in particular during the supine-to-standing manoeuvre) and that assessment during supine rest is inadequate for quantifying antenatal physiological function.

Dynamic analysis of beat-to-beat fetal heart rate variability recorded by SQUID magnetometer: quantification of sympatho-vagal balance.

BACKGROUND: Quantitative analysis of fetal heart rate variability (HRV) can be used to investigate the neural control mechanisms of fetal cardiac activity. However, conventional power spectrum methods do not reveal the full complexity of the time-varying sympatho-vagal balance in the fetus. AIM: This study was carried out to explore alternative digital signal processing methods of analysing fetal HRV in time domain (rather than frequency domain), in line with most types of physiological monitoring. METHODS: The beat-to-beat fetal heart rate was obtained by Superconducting Quantum Interference Device (SQUID) magnetocardiographic recording. These data were filtered within appropriately selected frequency bands: high frequency (HF) f>0.2 Hz, low frequency (LF) 0.05