Anthony R.B. Smith

Orthotopic reimplantation of cryopreserved ovarian cortical strips after high-dose chemotherapy for Hodgkin's lymphoma.

BACKGROUND Infertility is a common late effect of chemotherapy and radiotherapy, and has a substantial effect on the quality of life for young survivors of cancer. For men, semen cryopreservation is a simple way of preserving reproductive potential but for women, storage of mature eggs rarely proves successful, and the alternative-immediate in vitro fertilisation with cryopreservation of embryos-is not always appropriate. Reimplantation of cryopreserved ovarian tissue has been shown to restore natural fertility in animals. We applied this technique in a woman who had received sterilising chemotherapy for lymphoma. METHODS A 36-year-old woman underwent a right oophorectomy with cryopreservation of ovarian cortical strips before receiving high-dose CBV chemotherapy for a third recurrence of Hodgkins lymphoma. 19 months later, when serum sex steroid analysis confimed a postmenopausal state, two ovarian cortical strips were thawed and reimplanted-one onto the left ovary and another at the site of the right ovary. FINDINGS 7 months after reimplantation of ovarian cortical strips, the patient reported resolution of hot flashes and, for the first time, oestradiol was detected in the serum. This finding was associated with a decrease in the concentrations of follicle-stimulating hormone and luteinising hormone, and ultrasonography revealed a 10 mm thick endometrium, a poorly visualised left ovary, and a 2 cm diameter follicular structure to the right of the midline. The patient had one menstrual period, but by 9 months after the implantation, her sex steroid concentrations had returned to those seen with ovarian failure. INTERPRETATION Orthotopic reimplantation of frozen/thawed ovarian cortical strips is a well tolerated technique for restoring ovarian function in women treated with sterilising chemotherapy for cancer.

Stress incontinence and pelvic floor neurophysiology 15 years after the first delivery

Headline This is a longitudinal study of a cohort of primigravidae recruited between 1985 and 1987 and followed up 7 and 15 years later. Pelvic floor neurophysiology was performed and questionnaires were administered to determine the natural history of stress incontinence and to establish whether pelvic floor denervation after the first delivery is associated with symptoms of stress urinary incontinence in the future.

Virtual reality laparoscopic simulator for assessment in gynaecology

A validated virtual reality laparoscopic simulator minimally invasive surgical trainer (MIST) 2 was used to assess the psychomotor skills of 21 gynaecologists (2 consultants, 8 registrars and 11 senior house officers). Nine gynaecologists failed to complete the VR tasks at the first attempt and were excluded for sequential evaluation. Each of the remaining 12 gynaecologists were tested on MIST 2 on four occasions within four weeks. The MIST 2 simulator provided quantitative data on time to complete tasks, errors, economy of movement and economy of diathermy use—for both right and left hand performance. The results show a significant early learning curve for the majority of tasks which plateaued by the third session. This suggests a high quality surgeon–computer interface. MIST 2 provides objective assessment of laparoscopic skills in gynaecologists.

One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device

OBJECTIVE The purpose of this study was to evaluate outcomes after standardized transvaginal prolapse repair with nonanchored mesh and a vaginal support device. STUDY DESIGN Postoperative vaginal support was assessed by pelvic organ prolapse quantitative examination after repair of symptomatic stage II/III prolapse. Validated questionnaires assessed pelvic symptoms and sexual function. Visual analog scales quantified experience with the vaginal support device. RESULTS One hundred thirty-six women received the planned surgery; 95.6% of the women returned for the 1-year assessment: 76.9% of the cases were stage 0/I; however, in 86.9% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms, quality of life, and sexual function improved significantly from baseline (P < .05). Median visual analog scale scores for vaginal support device awareness and discomfort were 2.6 and 1.2, respectively (0 = none; 10 = worst possible). CONCLUSION Vaginal support, pelvic symptoms, and sexual function improved at 1 year, compared with baseline, after trocar-free prolapse repair with nonanchored mesh and a vaginal support device.

How accurate is symptomatic and clinical evaluation of prolapse prior to surgical repair

The aim of this study is to assess the accuracy of pre-operative evaluation of pelvic organ prolapse. The design is a prospective observational audit set at the gynaecology department, Teaching Hospital, UK. The population is composed of patients undergoing surgery for prolapse. One hundred and four patients admitted for prolapse surgeries were enrolled in the audit. Patients’ notes were initially reviewed for adequacy of prolapse assessment in the clinic. Patients were then interviewed by the researchers and assessed using a validated Prolapse Quality of Life (P-QOL) questionnaire. The presence of unrecorded symptoms was noted. Prolapse examination in theatre under anaesthesia was compared to the findings in the clinic and the operation performed compared to the proposed operation. The outcome measures were as follows: (1) number of patients who had accurate prolapse symptom assessment before surgery when comparing clinical records with entries on P-QOL questionnaires; (2) number of patients having symptoms related to their pelvic organ prolapse that were not accurately assessed pre-operatively; and (3) the differences, if any, between pre-operative and intra-operative examination of prolapse. Sixteen patients in our cohort (15%) had adequate assessment of their prolapse pre-operatively. Symptoms that were not adequately assessed in descending order were the impact of prolapse on quality of life (76%), sexual function (75%), bowel function (27%) and lower urinary tract symptoms (12.5%). Thirty one patients (30%) had sexual dysfunction, 24 (23%) had bowel symptoms and 23 patients (22%) had urinary symptoms that were not recorded before surgery. Prolapse physical examination was adequate in 59% of the cases. Examinations in theatre were different from clinic findings in 38 cases (37%); 16 cases (42%) had a greater or lesser degree of prolapse than that described in the notes; and 11 cases (29%) had prolapse in a different compartment in the vagina. A combination of both (i.e. different degree of prolapse and prolapse in a different vaginal compartment) was found in another 11 cases (29%). The operation performed was different from the one proposed in the clinic in 21% of the cases (n = 22). Clinical evaluation and examination of patients with vaginal prolapse is often inadequate. Prolapse physical examination in a clinic setting could be different from findings under anaesthesia. This can affect the operation to repair the prolapse. Patients should be counselled about this when listed for surgery.

A valsalvometer can be effective in standardising the Valsalva manoeuvre

A prospective randomised controlled study was performed in order to study the effectiveness of a device designed to reduce the variability in intra-abdominal pressures generated by individuals performing the Valsalva manoeuvre. One hundred women were recruited to take part in the project which compared a traditional Valsalva manoeuvre following standardised verbal instruction with forced expiration through a flow restriction device called a ‘valsalvometer’. The abdominal pressure was measured using an air-filled rectal balloon catheter linked to a pressure transducer. The use of the valsalvometer was associated with a reduction in variation of intra-abdominal pressure between women to 50% of the standard deviation. The new device has the capacity to reduce the variation in intra-abdominal pressure produced when performing the Valsalva manoeuvre. The rise in intra-abdominal pressure may act as a standard against which other measurements are made.

Why don’t women participate? A qualitative study on non-participation in a surgical randomised controlled trial

Introduction and hypothesisThe objective of the study was to identify reasons why women declined participation in a pilot randomised controlled trial (RCT) comparing tension-free vaginal tape (TVT) under general anaesthetic (GA) with single incision sling (SIS) under local anaesthetic (LA). These data would inform the design of a larger trial to improve patient recruitment.MethodsThis was a qualitative interview study on women eligible to have a TVT for stress urinary incontinence in a tertiary referral hospital in the UK. Women were counselled in a standardised manner. They were informed that the short-term success rates were similar for both operations. Women who declined to take part in the RCT were interviewed using a topic guide. Themes and sub-themes on non-participation were identified by two independent observers using a constant comparison method.ResultsTwenty-three non-participants of the RCT were interviewed. Common themes for non-participation were a preference for TVT and request for GA. Sub-themes showed that the TVT was preferred due to its perceived better efficacy as well as a minimal benefit from a SIS and also an unwillingness to take unknown risks. GA was favoured due to fear of local awareness, past negative experiences and embarrassment. Additional tests and follow-up visits were not cited as a reason for non-participation.ConclusionsThe study found that non-participants are not research averse in general but they had strong preferences about specific aspects of treatment. Risk propensity and personality may also influence this behaviour. The study also demonstrates how a qualitative pilot study may improve trial design.

Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study – results from the PROSPECT Study

BACKGROUND The use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy. OBJECTIVE To compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness. DESIGN Two randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon. Participants and outcome assessors were blinded to randomisation; participants were unblinded if they requested the information. Surgeons were not blinded to allocated procedure. SETTING Thirty-five UK hospitals. PARTICIPANTS Primary study: 2474 women in the analysis (including 1348 randomised) having primary anterior or posterior prolapse surgery. Secondary study: 398 in the analysis (including 154 randomised) having repeat anterior or posterior prolapse surgery. CC3: 215 women having either uterine or vault prolapse repair. INTERVENTIONS Anterior or posterior repair alone, or with mesh inlay, biological graft or mesh kit. MAIN OUTCOME MEASURES Prolapse symptoms [Pelvic Organ Prolapse Symptom Score (POP-SS)]; prolapse-specific QoL; cost-effectiveness [incremental cost per quality-adjusted life-year (QALY)]. RESULTS Primary trials: adjusting for baseline and minimisation covariates, mean POP-SS was similar for each comparison {standard 5.4 [standard deviation (SD) 5.5] vs. mesh 5.5 (SD 5.1), mean difference (MD) 0.00, 95% confidence interval (CI) -0.70 to 0.71; standard 5.5 (SD 5.6) vs. graft 5.6 (SD 5.6), MD -0.15, 95% CI -0.93 to 0.63}. Serious non-mesh adverse effects rates were similar between the groups in year 1 [standard 7.2% vs. mesh 7.8%, risk ratio (RR) 1.08, 95% CI 0.68 to 1.72; standard 6.3% vs. graft 9.8%, RR 1.57, 95% CI 0.95 to 2.59]. There were no statistically significant differences between groups in any other outcome measure. The cumulative mesh complication rates over 2 years were 2 of 430 (0.5%) for standard repair (trial 1), 46 of 435 (10.6%) for mesh inlay and 2 of 368 (0.5%) for biological graft. The CC findings were comparable. Incremental costs were £363 (95% CI -£32 to £758) and £565 (95% CI £180 to £950) for mesh and graft vs. standard, respectively. Incremental QALYs were 0.071 (95% CI -0.004 to 0.145) and 0.039 (95% CI -0.041 to 0.120) for mesh and graft vs. standard, respectively. A Markov decision model extrapolating trial results over 5 years showed standard repair had the highest probability of cost-effectiveness, but results were surrounded by considerable uncertainty. Secondary trials: there were no statistically significant differences between the randomised groups in any outcome measure, but the sample size was too small to be conclusive. The cumulative mesh complication rates over 2 years were 7 of 52 (13.5%) for mesh inlay and 4 of 46 (8.7%) for mesh kit, with no mesh exposures for standard repair. CONCLUSIONS In women who were having primary repairs, there was evidence of no benefit from the use of mesh inlay or biological graft compared with standard repair in terms of efficacy, QoL or adverse effects (other than mesh complications) in the short term. The Secondary trials were too small to provide conclusive results. LIMITATIONS Women in the Primary trials included some with a previous repair in another compartment. Follow-up is vital to identify any long-term potential benefits and serious adverse effects. FUTURE WORK Long-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates, need for further prolapse surgery, adverse effects and cost-effectiveness. TRIAI REGISTRATION Current Controlled Trials ISRCTN60695184. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 95. See the NIHR Journals Library website for further project information.

Is mid‐urethral placement of synthetic minimal access tapes important in stress urinary incontinence surgery?

The introduction of the tension free vaginal tape over a decade ago heralded the adoption of sub‐urethral sling placement under the mid‐urethra rather than the proximal urethra. This paper reviews the literature which led to the change in practice and also looks at which factors concerning tape position influence surgical outcome with particular reference to the position along the urethra. There is conflicting evidence on the importance of the mid‐urethral position and there is also evidence that other factors such as the configuration of the tape under the urethra at rest and under strain and the proximity of the tape to the urethral mucosa may be as important in influencing outcome. Further research is required. Neurourol. Urodynam. 29:676–678, 2010.

An evaluation of the efficacy of in-patient bladder retraining.

Abstract: This is a retrospective review of 50 consecutive patients with urinary frequency, urgency and urge incontinence, admitted in 1995 and early 1996 for bladder retraining in the form of timed voiding. At discharge 80% of the women were subjectively cured or satisfactorily improved, but this was significantly reduced to 32% of the 37 who replied to a postal survey between 12 and 29 months (mean interval 21.3 months) later. There were no significant associations between outcome and urodynamic diagnosis, reduced cystometric capacity, length of symptomatology, previous treatment or requirement for additional therapy, but this may have been in part due to small numbers. In conclusion, bladder retraining is a method of treatment for patients with both sensory urgency and detrusor instability which appears to be at least as successful as other modes of treatment for these conditions.