The Gynecel Trial for Pelvic Floor Reconstruction using a Biomaterial Mesh in women with symptomatic anterior vaginal wall prolapse

To assess the tissue regeneration efficacy and safety of the ADAPT (a new anti-calcification process for xenogenic tissue) treated bovine pericardial patch (BPP) in a pelvic floor reconstruction procedure. The ADAPT treated bovine pericardial patch will be placed as follows: General or regional anaesthesia may be administered according to the surgeon/anaesthetist preference. The patient is placed in the lithotomy position, with the buttocks slightly overhanging the table, followed by standard antiseptic preparation of the vulva and vaginal skin. Antibiotic prophylaxis is administered. The anterior wall vaginal incision is made vertically from approximately 1 cm below the cervix (or vault) ending approximately 2-3 cm from the bladder neck. The anterior vaginal wall edges are grasped with retraction hooks to maintain traction whilst a dissection of the vaginal wall is performed. The pubocervical fascia will be maintained on the vaginal wall. The dissection will be continued lateral to the bladder on each side into the paravesical space, creating a broad space lateral to the bladder with the aim of identifying the entirety of the arcus tendineus fasciae pelvis (ATFP), which extends from the posterior aspect of the pubic arch to the ischial spine. The Gynecel patch will then be fashioned to insert into this dissected space, with the aim of a tension-free attachment of each side of the patch to the ATFP on each pelvic side wall. The anterior and posterior aspects of the mesh will be stabilised in place by 2.0 Monocryl sutures at the bladder neck and the vault respectively, and the lateral edges attaching to the ATFP will be secured by Vicryl or titanium tacks, or sutures. Trimming of redundant vaginal skin is not advised. The vaginal skin incision is then repaired with 2.0 Vicryl with a continuous locking suture. A vaginal pack and urinary catheter are inserted at the end of the procedure for till the next morning. The procedure will take approximately 1 hour to perform, and is performed once only on each patient. The patient is retained as an in-patient and will follow the standard trial of void protocol of the Unit upon removal of the vaginal pack and catheter to identify any voiding dysfunction problems that may occur. The primary objectives are to evaluate the safety, efficacy and clinical performance of the ADAPT BPP. The above parameters will be assessed by documentation of: 1. Device related complication issues – which will be assessed by monitoring device implantation issues (intra-operatively), device strength and durability, device failure (as evidenced by recurrence of subsequent anterior vaginal wall prolapse)and post-operative infection rates. 2. Early (<30 days) morbidity – including haemorrhage (>500mls), blood transfusion, infection, bladder injury. 3. Long-term (up to 12 months) morbidity – including chronic infection, ulceration, calcification of the device, recurrence of prolapse. 2.2 Secondary Objectives The secondary objectives are to evaluate: 1. Design features – which will be assessed by monitoring use of the device intra-operatively, by allocating a score out of 10 for handling characteristics and shape and sizing characteristics, and recording associated suture/staple used to fix the device. 2. Objective Clinical Results – this will be assessed by objective measurement of the position of Point Aa (anterior wall 3cm proximal to the hymen) and Point Ba (leading-most point of anterior vaginal wall prolapse) by Pelvic Organ Quantification (POP-Q) score pre-operatively, and then at 6 weeks, 6 months and 1 year post-operatively. 3. Subjective Clinical Results – the validated Pelvic Floor Distress Inventory - Short Form 20 (PFDI-SF 20) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) will be used pre- and post-operatively to assess patients’ functional status.