ABSTRACT
INTRODUCTION: Japan's ageing crisis has brought major prolapse and incontinence problems. We hypothesized the problem was collagen leaching out of ligaments which support organs and could be corrected by the TFS (Tissue Fixation System) minisling which uses 7 mm wide tapes to create new collagen for ligament reinforcement.We analysed our 10-year experience (2009-2019) with TFS minisling prolapse repair with regard to one main question: "Is this technology of benefit to the ageing Japanese population?". MATERIAL AND METHODS: Retrospective analysis from two tertiary referral units; 3100 tapes were implanted (variously) into cardinal, uterosacral, arcus tendineus fascia pelvis (ATFP), perineal body ligaments of 960 Japanese women (mean age 69.6 years), to repair POPQ 3rd or 4th degree prolapse (918/960), 50% under local anesthesia/sedation, remainder general/spinal anesthesia. RESULTS: Patient discharge within 24 hours indicated minimal intra-operative problems. Prolapse cure at 12 months reached 90%. Complications requiring intervention were infected rectal perforation by tape, 3 delayed ileus complications. Eroded tapes (2.4-3.5%) were trimmed in the clinic. De novo long-term pain and major urine loss were virtually absent. CONCLUSIONS: The TFS system works by restoring ligament support (pubourethral, ATFP, cardinal, uterosacral, perineal body), differently from mesh sheets which work by blocking organ descent, which can lead to fibrosis of the vagina, and may cause chronic pain and massive incontinence. We had no such problems, because tapes have small volume, are applied transversely, with little vaginal contact. Specific ligament reinforcement with collagenopoietic tapes seems to be an important new direction for aged women with major prolapse, with high cure rate, acceptable complications, low erosions and virtually no long-term pain.
ABSTRACT
AIM: The ageing population in Japan brings problems of pelvic organ prolapse (POP), bladder and bowel incontinence, and fragility as regards major pelvic surgery. Existing data from tissue fixation system (TFS) surgery show high cure rates for these conditions, but long-term data are lacking. We aimed to elucidate the usefulness of TFS by assessing 5-year postoperative outcomes. METHODS: A total of 68 patients, mean age 70 years, underwent total pelvic floor repair. Cystocele, apical prolapse, and rectocele were variously addressed by TFS repair of pubourethral, arcus tendineus fasciae pelvis, cardinal, uterosacral, and perineal body ligaments using a mean 3.2 tapes per patient (n = 216). Patients were followed up at 12 months then yearly. We included patients with third- or fourth-degree uterine/vaginal prolapse (POP Quantification classification). We excluded patients with serious comorbid conditions. RESULTS: The mean operating time was 88 min and the mean blood loss was 78 mL. There was minimal postoperative pain and urinary retention, as evidenced by a mean hospital stay of 0.8 days and early return to normal activities. The 5-year cure rates for urinary stress incontinence, urgency, nocturia, and frequency were 82%, 91.7%, 58%, and 52%, respectively. The surgical cure rate for POP was 87.1% at 12 months, falling to 79.0 at 60 months. The cumulative 5-year erosion rate was 0% and 1.7% for all ligaments except the perineal body (25.7%), reducing to 2.6% by year 5 following anchor placement into deep transversus perinei. Two cases of ileus were attributed to incorrect technique. CONCLUSION: Reinforcing up to four ligaments with the TFS was sufficient for cure of third- and fourth-degree POP. The technique is minimally invasive, suitable for elderly women, and effective at 5 years for both anatomical and symptom cure.
