Original Article

The TFS minisling restores major pelvic organ prolapse and symptoms in aged Japanese women by repairing damaged suspensory ligaments – 12 - 48 month data

  • HIROMI INOUE
  • YUTAKA KOHATA
  • YUKI SEKIGUCHI
  • TUYOSHI KUSAKA
  • TAKANORI FUKUDA
  • MIKA MONNMA

Pelviperineology 2015;34(3):79-84

Background:

Ageing of Japan’s population has brought increases in pelvic organ prolapse (POP) and symptoms, creating problems for patient QOL, the health system, the community and government cost.

Objective:

To assess effectiveness of the Tissue Fixation System (TFS) in curing POP and symptoms of nocturia, urgency, frequency, chronic pelvic pain, fecal incontinence by suspensory ligament repair as predicted by the Integral Theory System.

Design, Setting, and Participants: a tertiary pelvic floor referral centre. Prospective observational study: 278 aged females (mean 69.6years), referred for primary POP repairs January 2009 - December 2012; initial 12 month and 4 year follow-up of original cohort.

Inclusion criteria: 3rd or 4th degree uterine/vaginal prolapse (POPQ classification).

Exclusion criteria: serious comorbid conditions.

Intervention(s): Damaged structures, ATFP, cardinal, uterosacral ligaments and perineal body were identified and repaired by an adjustable TFS tape attached to soft tissue anchors applying the same neoligament principle used in the TVT operation.

Outcome Measurements and Statistical Analysis:􀀚Follow-up: 12 months (n = 278), then yearly. 50/68 initial cohort reviewed at 4 years. Statistics: Lower and upper 95% confidence for observed relative frequencies of POP and symptoms were calculated for observed cure rates of 80%, 75% and 60% respectively (p < 0.05 Binomial Tests).

Surgical failure: any compartment prolapse for that patient at or beyond stage 2, (POPQ classification).

Results:

Mean hospital stay: 0.7 days (0-7); mean return to normal activities: 2.2 days. Surgical cure rate for POP (n = 278): 91.2% at 12 months, with a 10% fall at 48 months for original cohort (n = 68) to 84% (n = 50). Symptom cure rate at 12 months 278 patients: nocturia (n = 86) 72.1%; daytime frequency (n = 132) 90.1%; urgency (n = 133) 93.2%; chronic pelvic pain (n = 56) 93%; fecal incontinence (n = 52) 88.5%. Complications There were two early cases of ileus because of intraperitoneal placement of the tape, attributed to incorrect technique. Erosion rate (all TFS placements) 3.0% Excluding the perineal body tapes, the erosion rate was 9/989 = 1.1%

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Limitations 18 absent patients from the 4 year follow-up.

Conclusions:

The minimal nature and high cure rate of bladder and bowel symptoms may offer hope for reduction of admissions to Nursing Homes in the future. However, large multicenter more robust comparative studies will be required to more fully assess this method before such hopes can be justified.

Keywords: TFS; POP; Nursing homes; Cystocele repair; Perineal body repair; Rectocele repair; Uterine prolapse repair; Adjustable minisling.