Reinforcement of suspensory ligaments under local anesthesia cures pelvic organ prolapse: 12-month results

Abstract

Introduction and hypothesis: In 2005, a new minimally invasive procedure, the tissue fixation system (TFS) was reported. Like TVT (tension-free vaginal tape), the TFS works by creating a foreign body collagenous tissue reaction that reinforces a weakened pelvic ligament. The objective was to assess the effectiveness and perioperative safety of TFS in a day surgery clinic for the treatment of pelvic organ prolapse (POP).

Methods: The TFS tape was applied in a tunnel adjacent to natural ligaments to repair the anterior cervical ring and cardinal ligament, paravaginal tissues and uterosacral ligaments under local anesthesia/sedation. We prospectively studied 60 patients, mean age 67, between October 2008 and February 2010 at Women's Clinic LUNA. Levels of POP were grade 2 (n = 20; 7 %), grade 3 (n = 30; 55 %), and grade 4 (n = 4; 7 %) according to the ICS POPQ classification. Fifty-four patients (90 %) who underwent a total of 162 POP operations presented for review. Follow-up was performed at 12 months. We defined surgical failure according to the ICS POPQ classification. We used prolapse quality of life (P-QOL) questions for QOL measurement.

Results: Ninety-eight percent of patients were discharged on the day of surgery. Of the 162 TFS operations reviewed, 157 were successful and 5 failed. The 5 failed operations comprised 4 cystoceles and 1 rectocele. Two patients developed cervical protrusions at the introitus at 6 months with no prolapse of the uterine body. We found 5 cases of erosion in 162 tape insertions. The total number of patients who had no complications, no surgical failures, no erosions, no sensation of bulging, and no cervical protrusions was 47 (87 %).

Conclusions: The TFS uses the same surgical principle for repair as the TVT; this principle vastly minimizes the volume of mesh used, erosions, and other complications.

Fig. 1

The tissue fixation system (TFS). The TFS consists of two anchors (An) joined by a polypropylene mesh tape (T) passing through a one-way trapdoor at each base, which allows tightening. The anchor is fitted on top of the TFS applicator (Ap). The anchor is released into the tissues by activating the TFS applicator button (B)

Fig. 2

Repair principle using tensioned tapes: schematic diagram. Example: how the TFS repairs the uterosacral ligaments (USL). Blue solid line: tape prior to tightening; red broken lines: tape after tightening; black broken lines: replaced organ, ligaments, and connective tissues. CL lax cardinal ligament

Fig. 3

TFS for pelvic organ prolapse (POP). Cervical ring/cardinal ligament sling the anchors were put along the cardinal ligament beyond the lateral sulcus. TFS U-Sling The anchors were placed below the pubic ramus, extending onto the medial aspect of the obturator fossa, in the position of the ATFP insertion. USL TFS Sling The anchors were placed approximately 2 cm distal from the insertion of the uterosacral ligaments (USL) into the sacrum