An anatomical pathway for restoration of bladder neck closure by a midurethral sling, according to the integral theory.

A firm pubourethral ligament (PUL) is required to prevent the reflex posterior pelvic muscle forces forcibly opening out the posterior urethral wall on effort. A weak or loose PUL elongates on effort and this allows the posterior pelvic muscles to stretch open the posterior urethral wall causing urine loss, "stress urinary incontinence." Such forcible opening out of the urethra exponentially reduces the urethral resistance to flow inversely by the fourth power of the radius (i.e., 16 times). For example, if the radius doubles in size, the bladder pressure required for urine to flow out decreases by a factor of 16, from say, 160 to 10 cm H2 O. A midurethral sling reinforces PUL to prevent the urethra opening out, thereby restoring both the distal urethral and bladder neck closure mechanisms.

Late-occurring pain/other dysfunctions in midurethral sling class actions are likely caused by uterosacral ligament weakness, not implant or surgeon.

BACKGROUND: Large sums of money have been awarded against manufacturers of midurethral slings (MUS) because of complaints of pain and other complications, even though pelvic pain is rarely seen at the 6-12 weeks review. HYPOTHESIS AND AIMS: Pain/other posterior fornix symptoms (urge, frequency, nocturia, and abnormal emptying) may appear weeks or months after MUS surgery due to dislocation of already weakened uterosacral ligaments (USL), a consequence of diversion of pelvic forces from pubourethral ligaments strengthened by the sling. METHODS: Review for prevalence, pathogenic pathway from damaged USLs to pain, OAB, emptying, and other late complications by reference to data from functional anatomy imaging, mechanical support of USLs (speculum test), and post-USL surgical repair. RESULTS: Pelvic pain and other pelvic symptoms frequently co-exist pre-operatively with SUI, but are not volunteered because patients complain of one main pelvic symptom, others being "under the surface" (Pescatori Iceberg). Late de novo occurrence of symptom complications beyond perioperative MUS surgery may occur: pain (5.7%), retention (5.4%), UTI (9.3%), and OAB (10.2%). Xray/ultrasound evidence of pelvic forces acting on USLs support the hypothesis of diversion of forces. Improvement of pain and urgency by the "speculum test" indicates USL causation, as do cure of pain and other pelvic symptoms by USL slings. CONCLUSIONS: Late-occurring PFS symptoms are the fault of neither implant, nor surgeon, but more likely consequences of pelvic forces acting on USLs already weakened by childbirth/age. Bladder/bowel/pain symptoms need to be sought out preoperatively and discussed before MUS surgery. BRIEF SUMMARY: Late MUS complications, OAB, pain, retention subject to class actions, may be caused by uterosacral dislocation from pre-existing structural weakness, not surgeon or device.

The TFS mini-sling for uterine/vault prolapse repair: a three-year follow-up review.

AIMS: To assess the three-year prolapse recurrence rate of the tissue fixation system (TFS) posterior mini-sling, an operation that works much like a McCall procedure. PATIENTS AND METHODS: Patients who originally presented with major symptomatic prolapse were contacted by telephone three years after a posterior TFS mini-sling operation, and invited to attend for review. All patients were questioned as to recurrence of any lumps, 'dragging pain', satisfaction with the procedure and existence of any vaginal discharge. RESULTS: Of the original group of 39 patients, 35 were interviewed, 22 attended for review and four patients were uncontactable. Symptomatic cure was reported by 30 patients (86%), improvement in two (6%), and failure in three (9%). CONCLUSIONS: The longer-term results from the TFS posterior sling are encouraging. The procedure is evolving, and more studies are required.

The Tissue Fixation System provides a new structural method for cystocoele repair: a preliminary report.

BACKGROUND: A new reconstruction principle that uses tensioned tapes instead of large mesh is described for cystocoele repair. AIM: To apply this method to patients with central, paravaginal and cervical ring defects. METHODS: Ninety patients, mean age 63 years (29-83) and mean weight 73 kg (52-117 kg), underwent cystocoele repair using the Tissue Fixation System (TFS). Tapes were applied as a retro-obturator U-sling (n=29), transversely between both arcus tendineus fascia pelvis (ATFP) ligaments (n=45), along the path of the cardinal ligament in patients with cervical ring defects (n=12), and longitudinally along the ATFP ligament (n=4). RESULTS: At mean eight months review (three to 15 months), two failures were reported. There was one haematoma that drained spontaneously at seven days, and there were no erosions. Mean hospital stay was one a half days for the Australian group (one to seven days) and five days (four to eight days) for the European group. After using single U-sling, one patient required intermittent catheterisation for seven days before she could pass urine freely. In one patient the bladder was perforated during dissection laterally towards the ATFP; the perforation was successfully repaired. CONCLUSIONS: The tensioned tape operation is simple and accurate, and appears to work well in the short term. Longer-term studies are required.

Midurethral Tissue Fixation System sling -- a 'micromethod' for cure of stress incontinence -- preliminary report.

AIMS: To assess the effectiveness of the Tissue Fixation System (TFS) in patients with stress incontinence. The TFS uses two small plastic anchors to fix an (adjustable) midurethral polypropylene mesh sling into the soft tissues below the pubic bone. PATIENTS AND METHODS: Thirty-six patients with stress incontinence, mean age 55 (35-87), mean weight 76 kg (33-117 kg), mean 0.8 previous operations for stress incontinence, underwent a TFS midurethral sling operation. The patients were preoperatively assessed with a structured questionnaire, 24-h urinary diary, cough stress test, transperineal ultrasound, and urodynamics. Using the TFS delivery system, a midurethral mesh tape was attached to the fibromuscular tissues behind the perineal membrane. The suburethral vaginal fascia was also tightened. Post-operatively. the patients were reviewed at 6 weeks, and at 3-monthly intervals with ultrasound, and cough stress tests. RESULTS: Primary symptomatic cure rate at mean 9 months (3-15 months) was 83.4% (n = 36). Pad test loss decreased from a mean 12.7 g to a mean of 0.2 g; mean operating time was 5 min, and mean hospital stay was 24 h (12-48 h). There were no cases of obstructed micturition, and minimal analgesia only was required postoperatively. CONCLUSION: The TFS is a promising new method. The results at this stage are similar to those achieved previously with the 'tension-free' tape operations, but with greater safety and shorter operating time. Testing by other surgeons will be required to evaluate this method further.

Tissue Fixation System posterior sling for repair of uterine/vault prolapse -- a preliminary report.

AIMS: To assess the posterior Tissue Fixation System (TFS) sling for repair of uterine/vault prolapse. PATIENTS AND METHODS: The TFS comprises of two small polypropylene soft tissue anchors connected to an adjustable polypropylene tape. The posterior TFS sling works much like a McCall procedure. The anchors are inserted just lateral to the uterosacral ligaments. Tightening the sling elevates the prolapsed uterus/vaginal vault. The study group comprised 67 patients who were assessed with a 24-h urinary diary, structured questionnaire, transperineal ultrasound, urodynamics, cough stress test, and 24-h pad test, pre and postoperatively. RESULTS: Sixty-seven patients, mean age 65 years (35-87), mean weight 71 kg (38-117 kg), mean 1.6 previous pelvic operations, underwent posterior sling (level 1) repair for uterine/vault prolapse (fourth degree: n = 2; third degree: n = 17; second degree: n = 20; symptomatic first degree: n = 28). Level 2 (n = 18) and level 3 repairs (n = 18) were also performed as required. One patient was lost to the study. At mean 9 months' review (3-15 months), the prolapse repair had been successful in all but one patient. There were however, 14 de novo herniations postoperatively (20%), cystocoele 12, enterocoele 1, rectocoele 1. Operating time for the sling only was 5-10 min, and mean hospital stay was 1.5 days. Minimal analgesia was required. CONCLUSIONS: The preliminary results indicate that the TFS posterior sling appears to work well in patients with uterine/vault prolapse. Longer term follow up and studies by other surgeons are required to fully evaluate this procedure.