Prospective study of the Perigee™ system for treatment of cystocele - our five-year experience.

OBJECTIVES: The Perigee™ transobturator cystocoele repair system (AMS) was designed and first used in Townsville, Australia. In this study, we are reporting our five-year experience with the Perigee™ system in the management of cystocoele stage III and above. METHODS: Women who underwent surgery with the Perigee™ system between March 2004 and June 2008 were reviewed. Women who consecutively presented to our clinic with a stage III cystocoele or above were given information regarding the Perigee™ mesh surgery. Those who consented were included in our study. The study involved a POPQ assessment pre- and post-operatively at six weeks, three months, six months, 12 months and subsequently biannually. RESULTS: A total of 376 women underwent surgery with the Perigee™ system between March 2004 and June 2008, of which 26 were lost to follow-up. The anatomical success rate for the device was 94.3%, and there were no life-threatening complications with the procedure. 39 (11.1%) of women were found to have small mesh extrusion through the vagina, and 20 (5.7%) had recurrence of stage II cystocoele. Of the subset of women analysed, 45.1% reported no sexual dysfunction, 40.9% reported improvement in sexual function, while 4.1% reported worsening of dyspareunia. CONCLUSION: In this five-year experience, the Perigee™ system is deemed safe with an acceptable recurrence risk rate and complication rate. Further randomised controlled trials comparing Perigee™ system with traditional anterior colporrhaphy should be performed to evaluate mesh-based surgery safety and efficacy for level one evidence.

Prospective study of the Perigee system for the management of cystocoeles--medium-term follow up.

OBJECTIVES: The Perigee transobturator cystocoele repair system (AMS) was designed and first used in Townsville, Australia. This prospective study evaluates the efficacy and safety of this device for the management of cystocoeles. METHODS: Patients who underwent surgery with the Perigee system between March 2004 and December 2005 were reviewed. Patients who consecutively presented to our clinic with a stage 3 cystocoele or above were given information regarding the Perigee mesh surgery. Those who consented were included in our study. The study involved a questionnaire and POPQ assessment pre- and postoperatively at six weeks, three months, six months, 12 months and subsequently biannually. RESULTS: A total of 70 patients underwent surgery with the Perigee system between March 2004 and December 2005. There were no life-threatening complications with the procedure. Five (7.1%) patients were found to have small mesh extrusion through the vagina, and three (4.28%) patients had recurrence of stage 2 cystocoele. DISCUSSION/CONCLUSION: On medium-term evaluation (18 to 36 months) of the Perigee system the results seem very encouraging. The morbidity is minimal, as is the recurrence and mesh extrusion rate.

A multi-centre, randomised clinical control trial comparing the retropubic (RP) approach versus the transobturator approach (TO) for tension-free, suburethral sling treatment of urodynamic stress incontinence: the TORP study.

To compare the safety and efficacy of the transobturator tape (Monarc) with the retropubic tape (tension-free vaginal tape, TVTR) for the treatment of urodynamic stress incontinence (USI) a prospective, single-blinded, multi-centre randomised clinical controlled trial was undertaken in four urogynaecology units in Australia. One hundred and eighty-seven women with USI were randomly allocated to undergo surgery with either the Monarc sling (n = 80) or TVT (n = 107). Outcome measures were intra-operative complications (especially bladder injury), as well as peri-operative complications, symptomatology, quality of life and urodynamic outcomes. At 3 months, data were available on 140 women, 82 (59%) TVT and 58 (42%) Monarc. The TVT group was significantly more likely to be complicated by bladder injury (7 TVT, 0 Monarc, p < 0.05). Blood loss and operative time were significantly less in the Monarc group, which was 49 mls (31) vs that of the TVT group, which was 64 mls (41) p < 0.05; 18.5 min (6.5) TVT vs 14.6 min (6) Monarc (p < 0.001). The subjective and objective stress incontinence cure rates were 86.6% (71) vs 72.4% (42) p = 0.77 and 79.3 vs 84.5%, p = 0.51 for the TVT and Monarc groups, respectively. Both groups reported similar improvement in incontinence impact and satisfaction with their operation, although return to activity was significantly quicker with the transobturator route (p = 0.029). The transobturator tape appears to be as effective as the retro-pubic tape in the short term, with a reduction in the risk of intra-operative bladder injury, shorter operating time, decreased blood loss, and quicker return to usual activities.

A long-term review of posterior colporrhaphy with Vypro 2 mesh.

The objective is to study the long-term outcomes of posterior colporrhaphy with composite polyglactin 910-polypropylene mesh (Vypro 2, Ethicon, Somerville, NJ, USA) utilizing an overlay technique. Seventy-eight patients involved in our previous study were contacted 3 years after their initial operation for follow-up (Lim YN, Rane A, Muller R, Int Urogynecol J 16:126-131, 2005). Thirty-seven (47%) returned for follow-up and completed a standardized questionnaire survey, whereas a further 16 (20%) returned their postal questionnaires. Mean age was 61.3 (SD 10.8) years, and follow-up was 35.7 (SD 4.5) months. There were statistically significant improvements in vaginal lump sensation and constipation (p < 0.001) but no differences with defecatory difficulties or dyspareunia. De novo dyspareunia was reported in 27%. On examination, the incidences of mesh vaginal erosion and rectocele recurrence were 30% and 22%, respectively. It appears that posterior colporrhaphy incorporating Vypro 2 mesh with an overlay method is associated with unacceptably high incidence of complications.

Sling distress: a subanalysis of the IVS tapes from the SUSPEND trial.

AIM: To study the incidence of erosions and tape infections following the use of intravaginal slingplasty (IVS) treatment for stress urinary incontinence after the SUSPEND trial period of 30 months. This subanalysis was carried out because of concerns regarding high percentage of delayed sling erosions and infections during follow up of the patients who participated in the trial. MATERIALS AND METHODS: The subanalysis patient group consisted of all IVS patients drawn from the SUSPEND randomised control trial that compared the safety and efficacy of three types of suburethral slings, TVT, SPARC and IVS, for the treatment of urodynamic stress incontinence. RESULTS: A total of 62 patients were reviewed during this study conducted from April 2002 to May 2003. Continence was achieved in 88% the patients. A total of eight (13%) sling erosions were found requiring sling removal. Forty-eight (77.4%) patients were followed up at 12 months with one case of erosion (1.7%). Twenty-nine (46.8%) of the 62 patients were followed up between 12 and 34 months, and seven cases of sling erosions were diagnosed. One patient had purulent suprapubic sinus, five patients had foul-smelling discharge, and one had recurrent urinary tract infection associated with pain and discharge. After the slings were removed the patients had no further symptoms. However, three of them had recurrent stress urinary incontinence. DISCUSSION/CONCLUSION: The delayed presentation of the sling erosion from this subanalysis is a concern, and pelvic reconstructive surgeons using IVS need to be aware of the delayed presentations we found in our cohort of patients.

Suburethral slingplasty evaluation study in North Queensland, Australia: the SUSPEND trial.

OBJECTIVE: To compare the safety and efficacy of three types of suburethral slings for the treatment of urodynamic stress incontinence. METHODS: Following ethics approval, 195 (3 x 65) patients with urodynamic stress incontinence were randomly assigned to undergo suburethral slingplasty with the Tension-free Vaginal Tape (TVT; Gynecare, Ethicon, Somerville, NJ, USA), Intravaginal Sling (IVS; Tyco Healthcare, Mansfield, MA, USA), or Suprapubic Arc Sling (SPARC; American Medical Systems, Minnetonka, MN, USA). The patients were blinded to the type of sling implanted. MAIN OUTCOME MEASURES WERE: (1) operative and short-term complications; (2) pre- and postoperative symptomatology; and (3) pre- and postoperative urodynamic findings. RESULTS: There was a statistically significant increased rate of sling protrusion (13.1% vs. 3.3% and 1.7%; P = 0.04) in the SPARC group when compared to TVT and IVS. Otherwise, there were no significant differences between the groups with respect to the incidences of other operative complications, patients' main subjective outcomes, satisfaction rates, or postoperative urodynamic findings. The overall objective stress incontinence cure rates were 87.9%, 81.5% and 72.4% for the TVT, IVS, SPARC groups respectively (P = 0.11). CONCLUSIONS: All three slings appear quite successful for the treatment of stress incontinence. The SPARC tapes showed more sling protrusion complications and a trend towards lower objective cure rates; probably as a result of the insertion method used in this study which favoured a loose SPARC sling placement. The authors recommend that the SPARC slings be left tighter than TVT, or for the cough test to be carried out.

Transobturator tape for stress incontinence: the North Queensland experience.

A prospective observational study of 96 patients undergoing insertion of the MONARC transobturator tape (American Medical Systems, Minnetanka, USA) for treatment of urodynamic stress incontinence was conducted to investigate its' the safety and efficacy. Although there were no major intraoperative complications, sling protrusion was observed in 11/91 patients (12.1%) at early follow up visits. At these visits, 80 women (87.9%) were either completely or substantially continent and 74 women (81.3%) were satisfied with the operation. Objectively, 74 women (81.3%) were cured on urodynamic assessment and only one woman (1.1%) was found to have voiding dysfunction. As a conclusion, it would appear that this new technique is effective for the treatment of stress incontinence; but further studies are needed to investigate its long-term results and complications.