Polypropylene anterior-apical single-incision UPHOLD-LITE mesh surgery in women with severe pelvic organ prolapse: Outcome at 53 months follow up.

BACKGROUND AND PURPOSE: We present this current study to complement with mesh inlays plausible benefits (UPHOLD-LITE System) on available long-term study amidst FDA's concern on mesh complications. This study aims to assess the medium-term outcomes of UPHOLD-LITE system for treatment of advanced pelvic organ prolapse (POP) and its complications, and lower urinary tract symptoms. METHODS: This is a retrospective case series of 53 months follow-up of 123 consecutive patients who underwent UPHOLD-LITE system. Objective outcome measures the anatomical correction of prolapse with POP-Q ≤ Stage 1. Subjective outcome was patient's feedback to questions 2 and 3 of POPDI-6. Secondary outcome measures the quality of life, presence of lower urinary tract symptoms and complications. Quality of life is assessed by validated questionnaires on Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire 7 (IIQ-7), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ-12) at 1 and 3 years post-operatively. RESULTS: Objective outcome at 1 and 3 years was at 96.7 % and 95.4 % respectively. The subjective cure was 95.1 % and 91.6 %. Five-year cumulative cure rate maintained at 87.2 %. Secondary outcomes observed improvement on UDI-6, IIQ-7, POPDI-6 and PISQ-12 postoperatively. Bladder outlet obstruction improved while de novo urodynamic stress incontinence (USI) increased slightly post surgically. Mesh erosion rate was 0.8 %. CONCLUSION: The UPHOLD-LITE system demonstrated good medium term anatomical correction of apical and anterior prolapse, with good subjective cure and improved quality of life. Whilst complication rate was low, slight increase in de novo USI was observed.

Immunochemical and urodynamic outcomes after polypropylene mesh explant from the pelvic wall of rats.

INTRODUCTION AND HYPOTHESIS: To analyze the immunochemical and urodynamic outcomes after partial versus complete excision of transvaginal polypropylene mesh (PPM) from pelvic walls of rats. METHODS: Forty-eight female Sprague-Dawley (SD) rats were randomly distributed into seven groups: control, mesh total removal 60 days (M-T 60D), mesh total removal 180 days (M-T 180D), mesh partial removal 60 days (M-H 60D), mesh partial removal 180 days (M-H 180D), sham 60 days (Sham 60D), and sham 180 days (Sham 180D). In the mesh groups, PPM was inserted and partially (0.3 × 0.3 cm) or completely removed 30 days later. In the Sham group, the space between the vagina and bladder was dissected without placing or removing the synthetic mesh at day 1 and day 30 later. Urodynamic studies, immunochemical analysis, and Western blot were done at days 60 and 180. RESULTS: The M-T 60D voiding pressure was significantly decreased compared to the Sham 60D and M-H 60D. The voiding interval of M-T 60D was significantly shorter than that of M-H 60D. In the M-T 60D and M-T 180D groups, the leak point pressure was significantly less than in their corresponding sham groups. IL-1 and TNF-α were significantly more intense in M-T 60D compared to M-H 60D and Sham 60D. NGF was significantly greater in M-T 60D compared to Sham 60D. There were no significant differences in MMP-2 and CD-31s throughout the group. CONCLUSION: Total mesh excision incites a host inflammatory response and transitory lower urinary tract dysfunction. Despite the good outcomes after total excision, the invasiveness and surgical risk associated with repeated procedures should not be underestimateded.

Immunochemical analysis on polypropylene mesh: does mesh size make a difference?

INTRODUCTION AND HYPOTHESIS: The aim of the study is to demonstrate the impact of the size of implanted mesh in relation to its immunohistochemical reaction implanted into animal models. METHODS: An experimental study utilizing 54 female Sprague Dawley (SD) rats was divided into five groups: control, sham, and study groups (mesh-small [M-S], mesh-medium [M-M], mesh-large [M-L]). The M-S group used a mesh size of 0.2 × 0.2 cm, the M-M group a mesh size of 0.5 × 0.5 cm, and the M-L a mesh size of 0.7 × 1.0 cm. The sham group underwent vaginal dissection with no mesh implantation. The rats were sacrificed using isoflurane overdose on days 7 and 30. The mesh with the surrounding vaginal and bladder wall tissues were removed and processed for histochemical and western blot analysis. RESULTS: There is a significant increase in IL-1 and TNF-α immunoreactivity in the M-M and M-L groups on day 7 when compared with the sham group with p values of 0.001 and < 0.001 respectively. M-L showed significantly higher immunoreactivity to TNF-α persisting until day 30. All study groups presented a significantly higher immunoreactivity to MMP-2 and NGF on day 7. However, reactivity to NGF does not persist to day 30 in all groups. Immunoreactivity to CD 31 on days 7 and 30 appears significantly greater in the M-M and M-L groups, with the reaction in the M-L group continuing until day 30. CONCLUSION: Mesh size is directly proportional to the inflammatory reaction in the host tissue. The prolonged inflammatory process leads to delayed tissue remodeling and angiogenesis, which could delay mesh-tissue integration.

Assessment of collagen-coated anterior mesh through morphology and clinical outcomes in pelvic reconstructive surgery for pelvic organ prolapse.

STUDY OBJECTIVE: To assess the morphologic features of anterior armed transobturator collagen-coated polypropylene mesh and its clinical outcomes in pelvic reconstructive surgery to treat pelvic organ prolapse. DESIGN: Evidence obtained from several timed series with intervention (Canadian Task Force classification II-3). SETTING: Chang Gung Memorial Hospital, Taoyuan, Taiwan, China. PATIENTS: Between April 2010 and October 2012, 70 patients underwent surgery to treat symptomatic pelvic organ prolapse, stage III/IV according to the POP-Q (Pelvic Organ Quantification System). INTERVENTION: Anterior armed transobturator collagen-coated mesh. MEASUREMENT AND MAIN RESULTS: Morphologic findings and clinical outcome were measured. Morphologic features were assessed via 2-dimensional introital ultrasonography and Doppler studies. Clinical outcome was measured via subjective and objective outcome. Objective outcome was assessed via the 9-point site-specific staging method of the International Continence Society Pelvic Organ Prolapse Quantification before the operation and at 1-year postoperative follow-up. Subjective outcome was based on 4 validated questionnaires: the 6-item UDI-6 (Urogenital Distress Inventory), the 7-item IIQ-7 (Incontinence Impact Questionnaire), the 6-item POPDI-6 (Pelvic Organ Prolapse Distress Inventory 6), and the 12-item PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire), at baseline and at 12 months after the operation. Data were obtained for 65 patients who underwent the combined surgery and were able to comply with follow-up for >1 year. Ultrasound studies reveal that mesh length tends to shorten and decrease in thickness over the 1-year follow-up. Vagina thickness also was reduced. Neovascularization through the mesh was observed in <8.5% of patients in the first month and at 1 year, and was evident in approximately 83%. The mesh exposure rate was 6.4%. The recorded objective cure was 90.8% (59 of 65 patients), and subjective cure was 89.2% (58 of 65 patients) at mean (SD) follow-up of 19.40 (10.98) months. At 2 years, UDI-6, IIQ-7, and POPDI-6 scores were all significantly decreased (p < .001), whereas the PISQ-12 score was significantly increased (p = .01). CONCLUSIONS: Ultrasound features suggest that the degeneration of collagen barrier may be longer than expected and that integration of collagen-coated mesh could occur up to 1 year. A substantially good clinical outcome was noted.

The properties of absorbable scaffold harvested with human amniotic fluid stem cells on rat model: an innovation for pelvic reconstruction surgery.

The current practice of restoring the anatomical structure in the treatment of pelvic floor dysfunction includes implantation of synthetic sling, which carries potential complications. This study aimed to develop biological substitutes to improve tissue function using scaffolds as a support to the host cells, through formation of new tissue. Human amniotic fluid stem cells (hAFSCs) were seeded on synthetic mesh-scaffold of AlloDerm Regenerative Tissue Matrix (RTM), Poly-DL-lactico-glycolic acid (PLGA) mesh (VICRYL) and Polydioxanone (PDS) meshes. In vitro study evaluates the metabolic activity of hAFSCs seeded mesh-scaffolds. In vivo study involving Sprague-Dawley rats was performed by assigning into 7 groups of sham control with fascia operation, AlloDerm implant, PDS implant, PLGA implant, AlloDerm harvest with hAFSC (AlloDerm-SC), PDS harvest with hAFSC(PDS-SC) and PLGS harvest with hAFSC (PGLA-SC). In vitro study reveals cell viability and proliferation of hAFSC on mesh scaffolds varies between meshes, with AlloDerm growing the fastest. The biomechanical properties of tissue-mesh-complex tension strength declined over time, showing highest tension strength on week-1, deteriorated similar to control group on week-12. All hAFSC-seeded mesh provides higher tension strength, compared to without. This study shed the potential of synthetic mesh as a scaffold for hAFSC for the surgical treatment of pelvic floor dysfunction.

The immunohistochemical and urodynamic evaluation towards the collagen-coated and non-coated polypropylene meshes implanted in the pelvic wall of the rats.

Our aim is to study the inflammatory response towards the collagen-coated and non-coated polypropylene meshes in rats and the urodynamic investigation post-operatively. Forty-two female Sprague Dawley were divided into 7 groups of 6 rats; Control, Day 7 and 30 for Sham, Avaulta Plus (MPC), Perigee (MP). UDS were taken at days 7 and 30. Mesh with the vagina and bladder wall was removed and sent for immunohistochemical examination. Results showed intense inflammatory reaction on day 7 in the study groups which decreased on day 30. IL-1, TNF-α, MMP-2 and CD31 were observed to decrease from day 7 to day 30. NGF was almost normal on day 30 in all groups. UDS showed no difference in voiding pressure. Both Study and Sham groups had shorter voiding interval (VI) on day 7 but significantly lower in MPC. VI had significantly increased on day 30 in all groups. Voided volume was significantly lower in the mesh groups even when an increase was seen on day 30. In conclusion, the higher levels of IL-1, TNF-α and MMP-2 in collagen-coated polypropylene mesh imply greater inflammation than the non-coated polypropylene mesh. Mesh implantation can lead to shorter voiding interval and smaller bladder capacity.

Concomitant tension-free vaginal tape for urinary incontinence during laparoscopic hysterectomy.

OBJECTIVE: To evaluate the effectiveness and safety of placing tension-free vaginal tape (TVT) during a laparoscopically assisted vaginal hysterectomy (LAVH) in women with stress urinary incontinence and coexistent benign gynaecological disease. DESIGN: Retrospective clinical study (Canadian Task Force classification II-2). SAMPLE: Thirty patients diagnosed with genuine stress incontinence and benign gynaecological disease were studied. METHODS: All the patients underwent LAVH and concomitant TVT procedure. RESULTS: There was no significant difference in urodynamic parameters before and after surgery. All patients were followed postoperatively for a mean duration of 24.6 +/- 11.5 months (range 12-40). The cure rate of stress urinary incontinence was 96.7%. CONCLUSIONS: Concomitant placement of tension-free vaginal tape during a laparoscopically assisted vaginal hysterectomy proved to be an efficacious and safe procedure for women with benign gynaecological disease and coexistent stress urinary incontinence.

Tension-free vaginal tape procedures in women with stress urinary incontinence with and without co-existing genital prolapse.

PURPOSE OF REVIEW: Although the tension-free vaginal tape procedure has emerged as a feasible and effective alternative for a majority of urinary stress incontinence patients, the adaptation of the technique for genital prolapse has recently attracted much attention. This review focuses on the development of the tension-free vaginal tape procedure performed with transvaginal pelvic reconstructive surgery. RECENT FINDING: Articles since 1 April 2003 with older articles included for historical purposes were focused. Tension-free vaginal tape procedures used in prolapse surgery have mainly been performed according to the original technique. Adjustment of the vaginal tape is carried out after completion of the necessary prolapse procedures. The objective and subjective cure rate for urinary incontinence after tension-free vaginal tape with concurrent prolapse procedures is between 84.9 and 94%, and 67.3 and 88.6%, respectively. The mean complication rate, bladder perforation rate, transient urinary retention rate, period of catheterization and postoperative hospital stay are between 2.7 and 34%, 0 and 13%, 9 and 43%, 3.7 and 5.1 days, and 3.4 and 6.9 days, respectively. The implanted vaginal tape seems to 'give way' to the urethra and causes no urinary obstruction at least in studies with a short follow-up period. SUMMARY: The tension-free vaginal tape procedure performed with concurrent pelvic relaxation surgery appears to be a safe and effective treatment for urinary stress incontinence with co-existing vaginal pelvic prolapse. The implanted vaginal tape is prolapsed with the adjacent pelvic tissue, but the possibility of voiding dysfunction needs to be observed in a longer follow-up period.

Ultrasound assessment of mid-urethra tape at three-year follow-up after tension-free vaginal tape procedure.

OBJECTIVES: To evaluate the anatomic changes in the polypropylene mesh sling after a tension-free vaginal tape (TVT) procedure using introital ultrasonography in a prospective study. METHODS: Eighty women with genuine stress incontinence but without pelvic relaxation syndrome underwent surgery. Introital ultrasound evaluation of the mid-urethra TVTs was performed after surgery. RESULTS: Of the 70 women available for evaluation at postoperative year 3, 62 (88.5%) were objectively cured and 6 had improvement; in 2 patients, the procedure had failed. The measurement of the tape position from the bladder neck at the first and third year compared with the tape position at 1 month revealed no statistically significant differences. The tapes were located at the mid-urethra in 60 patients (85.7%) and at the proximal urethra in 10. The measurement of the tape from the lower margin of the symphysis pubis using the rectangular coordinate system showed the tape had a downward descent of 1.7 mm at 3 years of follow-up. The rate of descent decreased during the study period. The mean thickness and width of the tape increased with time. A urethral knee angulation during maximal straining was found in 60 patients (92%), with the tape positioned at the mid-urethra for the follow-up period. CONCLUSIONS: The observations of the tape position and characteristics suggest that shrinkage and compromise of the TVT sling does not occur. The TVT sling fixes to its original implanted site along the urethra and appears to slowly descend with the surrounding tissue with time. The urethra dynamic kinking contributes to the postoperative urinary continence when the TVT sling is placed at the mid-urethra.