Elevate and Uterine Preservation: Two-Year Results.

OBJECTIVE: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. MATERIALS AND METHODS: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. RESULTS: Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. CONCLUSIONS: Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusion.

Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.

OBJECTIVE: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. METHODS: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. RESULTS: Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%-93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%-99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001). CONCLUSIONS: Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.

Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to compare extrusion (vaginal mesh exposure) rates in patients undergoing transvaginal prolapse repair with the trocar-based Apogee and/or Perigee devices (American Medical Systems, Minnetonka, MN, USA) using either the original type I polypropylene mesh (IntePro, American Medical Systems, Minnetonka, MN, USA) or a newer generation lightweight type I mesh (IntePro Lite, American Medical Systems, Minnetonka, MN, USA). METHODS: Data were pooled from three similarly designed prospective multicenter studies evaluating the safety and efficacy of Perigee for correction of the anterior (AC) and/or Apogee to repair the posterior/apical (PC/A) compartments. The first two studies utilized IntePro (mesh density 50 g/m(2)) and the third utilized IntePro Lite (mesh density 25.2 g/m(2)). Data were pooled to form IntePro and IntePro Lite groups for comparison. Patient demographics were recorded. Risk factors for vaginal mesh exposure were also considered. RESULTS: Two hundred and sixty-three patients were implanted with Perigee and/or Apogee with IntePro for a total of 371 heavier mesh implants (174 Perigee, 197 Apogee) compared to 86 patients who underwent Perigee and/or Apogee with IntePro Lite for a total of 116 lightweight mesh implants (60 Perigee, 56 Apogee). Demographics and potential risk factors for extrusion were compared between the two groups. Mean follow-up was 2.0 years and similar between the two groups. In the AC, there were 234 implants, with mesh extrusion occurring in 8.0 % following IntePro compared to 5.0 % following IntePro Lite (p = 0.57). In the PA/C, there were 253 implants, with mesh extrusion occurring in 13.7 % following IntePro compared to 7.1 % following IntePro Lite (p = 0.25). Overall mesh extrusion rates in 487 implants in all compartments were found to be 11.1 % with IntePro versus 6.0 % with IntePro Lite with an estimated odds ratio of 1.93 (95 % confidence interval 0.84-4.44, p = 0.12). CONCLUSIONS: No statistically significant difference in extrusion rates were seen following use of IntePro versus IntePro Lite; however, the 46 % reduction in rate of mesh exposure observed in those receiving the lighter weight mesh may represent clinical importance.

Single-incision apical and posterior mesh repair: 1-year prospective outcomes.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. METHODS: This prospective multicenter study included 139 women with ≥ stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage ≤ I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. RESULTS: At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. CONCLUSIONS: The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considered.

Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse.

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh "kit" repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning.

Venous thromboembolism prophylaxis in gynecologic surgery: a systematic review.

OBJECTIVE: To comprehensively review and critically assess the available gynecologic surgery venous thromboembolism prophylaxis literature and provide clinical practice guidelines. DATA SOURCES: MEDLINE and Cochrane databases from inception to July 2010. We included randomized controlled trials in gynecologic surgery populations. Interventions and comparators included graduated compression stockings, intermittent pneumatic compression, unfractionated heparin, and low molecular weight heparin; placebo and routine postoperative care were allowed as comparators. METHODS OF STUDY SELECTION: One thousand two hundred sixty-six articles were screened, and 14 randomized controlled trials (five benign gynecologic, nine gynecologic oncology) met eligibility criteria. In addition, nine prospective or retrospective studies with at least 150 women were identified and provided data on venous thromboembolism risk stratification, gynecologic laparoscopy, and urogynecologic populations. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently screened articles with discrepancies adjudicated by a third. Eligible randomized controlled trials were extracted for these characteristics: study, participant, surgery, intervention, comparator, and outcomes data, including venous thromboembolism incidence and bleeding complications. Studies were individually and collectively assessed for methodologic quality and strength of evidence. Overall incidence of clinical venous thromboembolism was 0-2% in the benign gynecologic population. With use of intermittent pneumatic compression for benign major procedures, venous thromboembolism incidence was less than 1%. No venous thromboembolisms were identified in prospective studies of benign laparoscopic procedures. Overall quality of evidence in the benign gynecologic literature was poor. Gynecologic-oncology randomized controlled trials reported venous thromboembolism incidence (including "silent" venous thromboembolisms) of 0-14.8% with prophylaxis and up to 34.6% without prophylaxis. Fair quality of evidence supports that unfractionated heparin and intermittent pneumatic compression are both superior to placebo or no intervention but insufficient to determine whether heparins are superior to intermittent pneumatic compression for venous thromboembolism prevention. Combining two of three risks (aged 60 years or older, cancer, or personal venous thromboembolism history) substantially elevated the risk of venous thromboembolism. CONCLUSION: Intermittent pneumatic compression provides sufficient prophylaxis for the majority of gynecology patients undergoing benign surgery. Additional risk factors warrant the use of combined mechanical and pharmacologic prophylaxis.

Prospective evaluation of a single incision sling for stress urinary incontinence.

PURPOSE: We report 12-month outcomes of the MiniArc single incision sling for stress urinary incontinence in women. MATERIALS AND METHODS: We performed a multicenter, prospective, single arm institutional review board/ethics committee approved study evaluating the effectiveness of the MiniArc sling after implantation via qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) and quantitative (1-hour pad weight test and cough stress test) measurements. Secondary outcome measures included procedural variables (procedure time and estimated blood loss), length of stay, perioperative complications, Wong-Baker Faces Pain Scale and adverse events. RESULTS: A total of 188 women with a mean age of 51.1 +/- 10.6 years (median 50.4, range 25.9 to 79.6) were enrolled in the study. At 1 year 157 patients were available for analysis. Mean procedure time, estimated blood loss and length of hospital stay were 11.0 +/- 6.7 minutes (median 10, range 2 to 55), 41.7 +/- 47.0 ml (median 25, range 0 to 250) and 9.5 +/- 14.1 hours (median 3.2, range 0.5 to 77.2), respectively. At discharge from hospital the mean Wong-Baker pain score was 1.3 +/- 2.0 (range 0.0 to 10.0). Of the patients 90.6% had a negative cough stress test and 84.5% had a 1-hour pad weight test less than 1 gm at 12 months. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed a statistically significant decrease (p <0.001). Adverse events included urinary tract infection (4.3%), constipation (3.7%), temporary urinary retention (3.2%), dyspareunia (2.1%) and vaginal extrusion (1.6%). CONCLUSIONS: The MiniArc single incision sling is a safe and effective first line surgical procedure for the treatment of female stress urinary incontinence. It demonstrated excellent patient tolerability with minimal pain, early return to normal activity and low morbidity. In addition to sustained efficacy outcomes at 12 months patients treated with the MiniArc experienced a significant improvement in quality of life.

Graft use in transvaginal pelvic organ prolapse repair: a systematic review.

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0-3%), visceral injury (1-4%), urinary infection (0-19%), graft erosion (0-30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.

Modified Thiele massage as therapeutic intervention for female patients with interstitial cystitis and high-tone pelvic floor dysfunction.

OBJECTIVES: To evaluate the effectiveness of transvaginal manual therapy of the pelvic floor musculature (Thiele massage) in symptomatic female patients with interstitial cystitis and high-tone dysfunction of the pelvic floor. METHODS: A total of 21 women with documented interstitial cystitis and high-tone pelvic floor dysfunction underwent transvaginal massage using the Thiele technique twice a week for 5 weeks. Symptoms were evaluated before massage, at protocol conclusion, and at a mean of 4.5 months after therapy completion (long-term follow-up). The response to treatment was evaluated through the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes, Likert Visual Analogue Scales for urgency and pain, and Short-Form 12-item (SF-12) Quality-of-Life Scale, and through changes in the physical examination findings using a 5-point modified Oxford Scale to document pelvic floor tenderness. RESULTS: A statistically significant improvement was seen in the Symptom and Problem Indexes of the O'Leary-Sant Questionnaire (P = 0.015 and P = 0.039, respectively), Likert Visual Analogue Scales for urgency and pain (P = 0.001 and P = 0.005, respectively), the Physical and Mental Component Summary from the SF-12 Quality-of-Life Scale (P = 0.049 and P = 0.044, respectively), and the modified Oxford Scale (P <0.05) after protocol completion. At long-term follow-up, the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (P = 0.049 and P = 0.02, respectively), Likert Visual Analogue Scales for urgency and pain (P = 0.004 and P = 0.005, respectively), and modified Oxford Scale for three of four muscles in the pelvic floor (P <0.05) remained significantly improved. CONCLUSIONS: Thiele massage appears to be very helpful in improving irritative bladder symptoms in patients with interstitial cystitis and high-tone pelvic floor dysfunction in addition to decreasing pelvic floor muscle tone.

Anterior enterocele: a report of three cases.

Anterior enterocele is an uncommon finding in patients with pelvic organ prolapse. We reviewed 490 consecutive operations for pelvic organ prolapse . Three anterior enteroceles were identified in a series of 193 enterocele repairs (1.6%). The presentation and treatment of each of these patients is reviewed.