CONTENT

• Submissions for 2009
• Interim Reports from 2007 Grant Recipients
• Announcement of AGES Clinical Research Grants awarded in 2008
• Announcement of AGES Clinical Research Grants awarded in 2007
• Announcement of AGES Clinical Research Grants awarded in 2006
• Announcement of AGES Clinical Research Grants awarded in 2005
• Announcement of Recurrent Funding in 2005 for AGES Clinical Research Grants awarded in 2004
• Announcement of AGES Clinical Research Grants awarded in 2004
• Announcement of Recurrent Funding in 2004 for AGES Clinical Research Grants awarded in 2003
• Announcement of AGES Clinical Research Grants awarded in 2003

Submission details for Clinical Research Fund Applications for 2009

AGES has established a Clinical Research Fund with major contribution from Stryker Australia, Platinum Sponsor of AGES. The Society has undertaken to make available a total of up to $300,000 over three years for research into gynaecological surgery and its impact on improvements in women’s health.

You can download the information package as a .zip file (828Kb) of eight Microsoft Word files:

• Call for Submissions Fellows 2009
• Trainee Call for Submissions 2009
• Application Template
• 2008 Review Schedule for 2009 Grants
• Role of Research Grant Committee
• Ethical Principles
• Interim Reports 2008 Grants
• Interim Reports 2009 Grants

The closing date for submission has been extended to 14 November 2008

Interim Reports from 2007 Grant Recipients.

The MAP (mesh for anterior prolapse) trial — Paul Duggan
This multicentre randomised controlled trial is comparing the outcome of traditional anterior colporrhaphy against anterior Prolift mesh repair for women presenting with anterior compartment vaginal prolapse of at least POP-Q stage 2 (i.e. at maximal straining the lowermost part of the anterior wall is 1cm above the hymenal ring, or worse).  We are expecting a 30% rate of surgical failure in the traditional group and 10% failure in the mesh group. The primary end-points are anatomical correction of the anterior compartment prolapse and quality of life.  Secondary end-points include surgical complications and relative costs.  Additional procedures, such as hysterectomy, incontinence procedures and posterior compartment repair are permitted and anatomical and functional correction in these compartments will be evaluated also as secondary end-points.  The POP-Q system is used to evaluate the anatomical result and the P-QOL questionnaire is used for evaluation of quality of life.  The P-QOL questionnaire is a validated instrument developed by the King’s unit for this type of research.  The POP-Q and P-QOL data are to be compared pre-operatively and at six months and two years after surgery.  The research has been approved in four public gynaecology units in Adelaide and at present three units are contributing patients – the Royal Adelaide Hospital, The Queen Elizabeth Hospital and the Lyell McEwin Hospital.  We are keen to hear from colleagues in other units in Australia who may be interested in participating in this trial. Please contact the principal researcher, Paul Duggan, Senior Lecturer, Gynaecology Unit, Royal Adelaide Hospital (telephone 08 8222 4816) for further information.

The BIDO (Botulinum toxin for Idiopathic Detrusor Overactivity) trial — Paul Duggan
This single centre randomised dose-response trial is comparing the effect of the intradetrusor injection of Botulinum A toxin (100 or 200 units) in women with detrusor overactivity and who have not responded to conventional therapy.  Women are required to cease all anticholinergic therapy at least two weeks before injection.  The primary endpoints are the time taken from injection to recommencement of anticholinergic drugs or other therapy for recurrent detrusor overactivity, the effect on quality of life using a disease-specific, validated questionnaire, and rates of urinary retention following injection.

Analysis of 1531 endometriosis biopsies taken from 471 patients in the AWARE study — Luk Rombauts, Michael Cooper, Susan Evans, Jim Tsaltas, Lis Young, Geoff Reid.
The Endocan study provides evidence that surgical treatment of minimal and mild endometriosis improves the fecundity of women trying to conceive naturally. The effectiveness of surgery for patients presenting with pelvic pain has been less convincing so far. The correlation between the experienced pain and the extent of the disease, as scored in the rAFS classification, is weak. Similarly, it is difficult to predict based on the rAFS classification alone which individual patients will report pain relief after surgery and the overall recurrence rate of pelvic pain can be as high as 60%. A number of factors, such as surgical technique, severity of the disease and other more patient-specific factors are probably important in determining how surgery will affect the patients outcome.

The aim of this study was to further define what predicts a successful surgical outcome.

We analysed a total of 1556 biopsies were taken from 471 patients undergoing a laparoscopy for infertility and/or pain in the AWARE cohort. All lesions were classified at surgery as superficial or deep. The size was estimated as <100mm³, 100 to 1000mm³ or >1000mm³. Information was collected regarding the site and final histology. Hierarchical clustering analysis (HCA) was performed to group variables according to their maximal degree of association.

Our results confirm previous reports that endometriosis shows a statistically significant trend to be more left-sided with 35.9% of the biopsies classified as left-sided as opposed to 31.8% for right-sided lesions. Fifty one percent of the biopsies from patients with minimal endometriosis and 19.5% - 25.0% of the lesions from patients with mild to severe disease could not be confirmed as endometriotic lesions.

HCA confirmed that pelvic pain, dysmenorrhea, dyspareunia, and dyschezia clustered closely together. HCA also demonstrated that lesion depth clustered more closely to AFS stage than lesion volume. Interestingly, none of the pain types clustered with any of the biopsy variables or even the AFS score, despite using several different HCA strategies. Pain scores did improve following surgery, but the percent change was not correlated with AFS score or any of the biopsy variables. Interestingly, there was a significant inverse relationship between depression score and pain improvement.

In conclusion, the fact that post-operative pain improvement is not predicted by classical measures such as the AFS score, but by the patient’s preoperative psychological well-being, suggests that more work needs to be done to find effective strategies that maximise the benefits of the surgical intervention.

Hysterectomy versus uterine conservation for prolapse of the upper vagina. - Juneja M, Barry C, Munday D
The following is a summary of the progress of the study to date:
Ethics approval was obtained from the institutional human research and ethics committee at the Queen Elizabeth Hospital in Adelaide. The study began in February 2007.This is a pilot study based on the hypothesis that anatomical correction and reduction in prolapse recurrence can be achieved without hysterectomy at the time of surgery for upper vaginal prolapse. The study design is a prospective, randomised trial comparing vaginal hysterectomy to uterine conservation. All patients have posterior infra-coccygeal mesh augmentation sacropexy using the Apogee vaginal vault repair system. Corrections of anterior compartment defects are performed at the same time either using native fascial tissue or mesh at the discretion of individual surgeon. The mandatory inclusion criteria are predominant uterine prolapse of grade 2 or more (C -1 or greater based on quantitative POP-Q scoring), no uterine or cervical disease warranting hysterectomy and willingness to be randomised to hysterectomy or uterine conservation.

The pre-operative evaluation includes pelvic and renal ultrasound as well as urodynamic evaluation if there is large anterior compartment defect or stress urinary incontinence. Women are asked to complete three validated questionnaires pre-operatively as well as at 6 months and yearly follow up.   The questionnaires are Prolapse-Quality of life (P-QOL), Sheffield prolapse symptoms questionnaire (SPS-Q) and Pelvic organ prolapse /urinary/sexual function questionnaire (PISQ-12).The primary outcome measure is objective measurement  of anatomical resolution of prolapse with point C at least - 6 cm above the hymen and no prolapse of grade 2 or more at any other anatomical site. Other secondary outcome criteria include subjective success rate, duration of surgery, operative morbidity, post-operative analgesic requirement, impact on bladder & sexual function and mesh related complications. The post-operative evaluation for anatomical outcome at 6 monthly and annual visits is being undertaken by an independent evaluator (consultant gynaecologist not involved in the study).

The intended target was inclusion of 20 women in the first year, however recruitment has been slower than expected and 18 women have been included so far in the study. This can be attributed to current practice of offering conservative therapy using support pessaries and pelvic floor exercises, secondly a large proportion of women referred to the hospital have already undergone hysterectomy .Overall the acceptability of the study has been good. Despite being informed other risk of mesh erosion pre-operatively, most  women in the study  have  not expressed any concern about use of synthetic mesh  and are  keen to have a single operation with the chance of higher cure rate. Sixteen out of eighteen recruited women have undergone surgery and the other 2 have been listed. To date there has been no serious adverse event that required reporting to the local human ethics research committee. There have been 2 cases of mesh erosion so far. The first patient experienced symptomatic mesh erosion/infection 4 weeks after surgery and was managed with antibiotics and trimming in the uterine conservation group. The second patient belonged to the hysterectomy arm and had asymptomatic mesh exposure discovered at the six monthly visit. None of the patients have required surgery so far for apical recurrence. We intend to undertake an interim analysis at the end of this year. After 2 years of follow-up, we intend to submit the paper for publication in a peer reviewed journal. We acknowledge the support of AGES and will provide a further report next year.

Laparoscopic sacral colpopexy versus total vaginal mesh surgery for vaginal vault prolapse: A randomised control trial - A Prof Christopher Maher

I am delighted to report that the progress in the study has been excellent and is as predicted in the study timeline. Ethics committee approvals were completed in 2006 and 110 women with symptomatic vaginal vault prolapse extending to or beyond the introitus were recruited by end 2007 and surgery completed by end March 2008.

Patients are undergoing 6-monthly POP-q assessment and completing validated Queensland Pelvic Floor and Kings college QoL POP questionnaire. The last review will be in November and we are hoping to achieve a mean 2-year review for the initial study which we hope to present and publish in 2009.

Other than the ongoing difficulties with ensuring women return for reviews there has been no unforeseen problems. This study would not have been possible with the expert assistance of our Research and continence nurses which have been part funded by the research grant from AGES in 2006 & 2007 for which we remain extremely grateful.

We look forward to presenting the study to the AGES in 2009.

Assessment of changes in multi-compartmental prolapse after laparoscopic pelvic floor reconstruction using static and dynamic magnetic resonanc eimaging - K. Johnston G. Cario, D. Chou, D. Rosen, D. Moses
Aims:  A prospective consecutive longitudinal series to quantitate the degree of multi-compartment prolapse before and after laparoscopic pelvic floor reconstruction using MRI.

Methods and materials:  Twenty women (mean age 53 yrs, range 28-73 yrs) with multi-compartmental prolapse were imaged before and after laparoscopic pelvic floor reconstructions. Patient consent and IRB approval was sought prior to imaging. A 1.5 T MRI assessed the pelvic floor using the following sequences: sagittal, axial and coronal high resolution T2 TSE sequences at rest; axial, sagittal and coronal ssFSE sequences at rest and during maximal strain; and sagittal and axial steady state preprecession T2 weighted images dynamically while the patient alternated between rest and maximal strain. Quantitative evaluation included construction of the pubococcygeal line (PCL), measurement of the anterior posterior genital hiatus (“H” line), measurement of the vertical decent of the levator hiatus (“M” line) and calculation of levator plate angulation.

Results:  A decrease in the AP dimensions of the genital hiatus (H line) was noted postoperatively in 15 of the 20 patients (75%). The mean improvement was 18 mm (range 2 to 81), p=0.02. Pelvic floor decent (M line), improved post operatively in 12 of the 20 patients (60%), p=0.047. The mean improvement was 19 mm (range 4 to 73). A decrease in the degree of levator plate angulation was noted in 17 of the 20 patients (85%). The mean decrease was 19 degrees (range 3 to 56), p=0.015.

Conclusions:  Definitive and statistically significant changes were seen in the quantitative parameters before and after laparoscopic pelvic floor reconstruction. Our surgeons believe that the superb, magnified view of the pelvic floor offered by laparoscopy facilitates the optimal approach to reconstructive surgery. This is supported by the post-operative MRI measurement improvements seen in high percentages of patients.

Clinical relevance and application: MRI’S role in pelvic floor prolapse continues to develop as a non invasive technique which provides excellent dynamic and static visualization of the pelvic anatomy. MRI offers an objective modality in assessing the outcome of the various techniques of pelvic floor surgery and in doing so will hopefully help define optimal surgical reconstructions
(The quality of life analysis and POP-Q assessment still to be statistically correlated)

Announcement of AGES Clinical Research Grants awarded in 2008

The Research Committee, chaired by Associate Professor Peter Maher, has awarded new grants to five of the nine grant applicants. All of these are new grants. A total of $62,000 has been awarded. As in past years, two independent referees with no apparent conflict of interest were selected for each application. The applications were also reviewed by Associate Professor Peter Maher and Dr David Munday.

A high priority was given to funding for College trainees and to encourage young Fellows. The Committee was very pleased to award two grants of $5,000 to trainees this year.

AGES appreciates the significant contribution by Stryker to this important long-term project.

Announcement of AGES Clinical Research Grants awarded in 2007

The Research Committee, chaired by Professor Ian Fraser, has awarded new grants to three of the five grant applicants, and renewed funding to three of three applicants. A total of $77, 046 was awarded in 2007. As in past years, two independent referees with no apparent conflict of interest were selected for each application. The applications were also evaluated by Professor Fraser and/or Dr David Munday.

Announcement of AGES Clinical Research Grants awarded in 2006

The Research Subcommittee, chaired by Professor Ian Fraser, has awarded new grants to six of seven grant applicants. No recurring grant funding was sought. A total of $90,000.00 has been awarded for 2006. As in past years, two independent referees with no apparent conflict of interest were selected for each application. The applications were also evaluated by Professor Fraser and/or Dr David Munday.

Announcement of AGES Clinical Research Grants awarded in 2005

The AGES Research Sub-Committee chaired by Prof. Ian Fraser has awarded grants in 2005 to four of five grant applications. All applications were sent to two independent referees, with the final judging undertaken by those members of the Sub-Committee who had no conflict of interest.
The successful applicants are:

Those applicants who applied for a second year of funding have been advised that these applications will be favourably reviewed by the Research Grant Subcommittee in late 2005, subject to a satisfactory detailed report on the progress of the research in the first 9-10 months of this year. Both an interim and final report are required.

It is anticipated that all grant recipients will submit their results for publication in a peer-reviewed journal. Proper accounting of all projects is expected, and any unspent funds must be returned to AGES.

Announcement of Recurrent Funding in 2005 for AGES Clinical Research Grants awarded in 2004

Announcement of AGES Clinical Research Grants awarded in 2004

The AGES Research Sub-Committee chaired by Prof. Ian Fraser has awarded grants in 2004 to four of eight grant applications. All applications were sent to two independent referees, with the final judging undertaken by those members of the Sub-Committee who had no conflict of interest.
The successful applicants are:

Those applicants who applied for a second year of funding have been advised that these applications will be favourably reviewed by the Research Grant Subcommittee in late 2004, subject to a satisfactory detailed report on the progress of the research in the first 9-10 months of this year. Both an interim and final report are required.

It is anticipated that all grant recipients will submit their results for publication in a peer-reviewed journal. Proper accounting of all projects is expected, and any unspent funds must be returned to AGES.

Announcement of Recurrent Funding in 2004 for AGES Clinical Research Grants awarded in 2003

AGES Clinical Research Grants awarded in 2003