Outcomes and complications of transvaginal and abdominal custom-shaped light-weight polypropylene mesh used in repair of pelvic organ prolapse.

STUDY OBJECTIVE: To assess the outcomes and complications of transvaginally placed custom-shaped light-weight polypropylene mesh for repair of pelvic organ prolapse. DESIGN: Retrospective review of medical records (Canadian Task Force classification II-2). SETTING: Two urogynecologic centers. PATIENTS: Between March 2006 and September 2007, 154 women with anterior, posterior, or apical prolapse underwent vaginal reconstructive surgery using custom-shaped transvaginal or abdominal mesh. Surgical procedures were chosen after informed consent. The primary outcome for the study was recurrence of prolapse, defined as POP-Q (Pelvic Organ Prolapse Quantitative) stage II or greater. Secondary end points included perioperative and postoperative complications. INTERVENTIONS: Anterior compartment repair was performed in 94 patients (61%), and posterior compartment repair in 60 (39%). Combined anterior and posterior repairs were performed in 25 patients. Hysterectomy was performed in 27 patients (18%) (abdominal in 1, vaginal in 19, and laparoscopy-assisted in 7). Apical support techniques included sacrospinous fixation in 69 patients (45%), abdominal sacral colpopexy in 30 (19%), and vaginal culdoplasty in 7 (5%). Transobturator sling procedures were performed in 65 patients (42%). MEASUREMENTS AND MAIN RESULTS: Postoperative follow-up exceeded 24 months in all patients. The overall success of these procedures was 97.4%. There were 4 failures (2.6%), defined as stage II prolapse or greater. Comparison of POP-Q points Aa, Ba, C, Ap, and Bp preoperatively and postoperatively revealed statistically significant improvement at each point (p <.001). Complications were observed in 17 patients (11%), with mesh extrusion in 1 (0.7%). CONCLUSIONS: Long-term follow-up demonstrated that use of custom-shaped light-weight polypropylene mesh is safe and effective, with a low rate of complications.

Site-specific rectocele repair with dermal graft augmentation: comparison of porcine dermal xenograft (Pelvicol) and human dermal allograft.

This study is a retrospective chart review comparing 195 women who underwent rectocele repair with either a porcine dermal xenograft or human allogenic cadaveric dermal graft augmentation over a two year period. A site-specific defect repair was completed prior to augmentation with the graft. Examinations were performed preoperatively and postoperatively using the pelvic organ prolapse quantification system. Questionnaires were used to assess constipation and dyspareunia. De novo dyspareunia and cure rates for constipation and dyspareunia were not statistically different between the two groups. Site-specific fascial rectocele repairs with xenograft or allograft augmentation were found to have similar complication rates as well as objective and subjective cure rates.

Posterior repair with perforated porcine dermal graft.

OBJECTIVE: To compare postoperative vaginal incision separation and healing in patients undergoing posterior repair with perforated porcine dermal grafts with those that received grafts without perforations. Secondarily, the tensile properties of the perforated and non-perforated grafts were measured and compared. MATERIALS AND METHODS: This was a non-randomized retrospective cohort analysis of women with stage II or greater rectoceles who underwent posterior repair with perforated and non-perforated porcine dermal grafts (Pelvicol(TM) CR Bard Covington, GA USA). The incidence of postoperative vaginal incision separation (dehiscence) was compared. A secondary analysis to assess graft tensile strength, suture pull out strength, and flexibility after perforation was performed using standard test method TM 0133 and ASTM bending and resistance protocols. RESULTS: Seventeen percent of patients (21/127) who received grafts without perforations developed vaginal incision dehiscence compared to 7% (5/71) of patients who received perforated grafts (p = 0.078). Four patients with vaginal incision dehiscence with non-perforated grafts required surgical revision to facilitate healing. Neither tensile strength or suture pull out strength were significantly different between perforated and non-perforated grafts (p = 0.81, p = 0.29, respectively). There was no difference in the flexibility of the two grafts (p = 0.20). CONCLUSION: Perforated porcine dermal grafts retain their tensile properties and are associated with fewer vaginal incision dehiscences.

Risk of mesh extrusion and other mesh-related complications after laparoscopic sacral colpopexy with or without concurrent laparoscopic-assisted vaginal hysterectomy: experience of 402 patients.

STUDY OBJECTIVE: To estimate the incidence of mesh-related complications including mesh erosion/extrusion rates in patients undergoing laparoscopic sacral colpopexy, with or without concurrent hysterectomy, using macroporous soft polypropylene mesh. DESIGN: Historical cohort study (Canadian Task Force classification II-2). SETTING: Private urogynecology clinic. PATIENTS: A total of 446 consecutive patients with uterovaginal or vaginal vault prolapse underwent laparoscopic sacral colpopexy with use of macroporous soft polypropylene mesh from January 2003 through January 2007. In all, 402 consecutive patients met enrollment criteria. Two groups of patients were identified: (1) those receiving concurrent hysterectomy (n = 130); and (2) those with a history of hysterectomy (n = 272). INTERVENTIONS: Patients were treated with laparoscopic sacral colpopexy with use of macroporous soft polypropylene mesh in conjunction with other laparoscopic and/or vaginal procedures. MEASUREMENTS AND MAIN RESULTS: Data were collected in the form of chart reviews and patient questionnaires. Comparisons were made between groups 1 and 2. Patient demographics, history, mesh erosion/extrusion rates, and mesh-related complications were analyzed. Length of follow-up was 1 to 54 months with a median follow-up time of 12 months. No statistically significant differences existed between 2 groups in rates of mesh erosion/extrusion or other mesh-related complications. Overall vaginal mesh erosion/extrusion rate was 1.2% (95% CI 0.5%-2.7%) with an associated mesh revision rate of 1.2% (95% CI 0.5%-2.7%). Patients with concurrent hysterectomy had an erosion/extrusion rate of 2.3% (3/130) as compared with 0.7% (2/272) in patients with a history of hysterectomy, p = .18. No cases of mesh erosion through organs and tissues other than vaginal mucosa were observed. Cuff abscess occurred in 1 patient with concurrent hysterectomy, with an overall infection rate of 0.3% (95% CI 0.01%-1.2%). One more patient developed an inflammatory reaction to the mesh. Excision of exposed mesh was performed in all 5 patients with mesh extrusion. Vaginal approach to excision was uniformly used. Laparoscopic removal of the entire mesh took place in 4 patients with persistent pelvic pain, in 1 patient with cuff abscess, and in one patient with a questionable mesh reaction. An estimated 975 to 17 000 patients were required in each group to achieve power to detect a statistically significant difference in rate of mesh-related complications in this study. CONCLUSION: Risk of mesh extrusion or other mesh-related complications after laparoscopic sacral colpopexy using soft macroporous Y-shaped polypropylene mesh is about 1% in our study. No significant increase in risk of mesh-related complications was observed in patients receiving concurrent hysterectomy when compared with patients who had a previous hysterectomy. The sample size of almost 2000 patients was needed to detect a statistically significant difference in rate of mesh-extrusion in this study.

Posterior repair with perforated porcine dermal graft

OBJECTIVE: To compare postoperative vaginal incision separation and healing in patients undergoing posterior repair with perforated porcine dermal grafts with those that received grafts without perforations. Secondarily, the tensile properties of the perforated and non-perforated grafts were measured and compared. MATERIALS AND METHODS: This was a non-randomized retrospective cohort analysis of women with stage II or greater rectoceles who underwent posterior repair with perforated and non-perforated porcine dermal grafts (PelvicolTM CR Bard Covington, GA USA). The incidence of postoperative vaginal incision separation (dehiscence) was compared. A secondary analysis to assess graft tensile strength, suture pull out strength, and flexibility after perforation was performed using standard test method TM 0133 and ASTM bending and resistance protocols. RESULTS: Seventeen percent of patients (21/127) who received grafts without perforations developed vaginal incision dehiscence compared to 7 percent (5/71) of patients who received perforated grafts (p = 0.078). Four patients with vaginal incision dehiscence with non-perforated grafts required surgical revision to facilitate healing. Neither tensile strength or suture pull out strength were significantly different between perforated and non-perforated grafts (p = 0.81, p = 0.29, respectively). There was no difference in the flexibility of the two grafts (p = 0.20). CONCLUSION: Perforated porcine dermal grafts retain their tensile properties and are associated with fewer vaginal incision dehiscences.

Posterior vaginal sling experience in elderly patients yields poor results.

OBJECTIVE: The objective of the study was to evaluate our experience with the posterior vaginal sling in an elderly population. STUDY DESIGN: Elderly patients with significant vaginal prolapse underwent a posterior vaginal sling using the IVS Tunneller device (Tyco Healthcare, United States Surgical, Norwalk, CT). Primary failure was defined as a postoperative pelvic organ prolapse quantitative point C (the apex of the vagina) within 2 cm of the preoperative value. Secondary failure was defined as any portion of the anterior or posterior vaginal walls protruding to or beyond the hymeneal ring (pelvic organ prolapse quantitative points Aa or Ap equal to or greater than 0). RESULTS: Twenty-one patients underwent the procedure; 19 were seen for follow up. The average age was 70 years (range 60-78). Twelve patients had primary or secondary failures (12 of 19, 63%). There were 5 primary failures (5 of 19, 26%) and 7 secondary failures (7 of 19, 37%). The mean time to failure was 7 weeks (range 1-18). CONCLUSION: In our elderly population, the posterior vaginal sling has a high failure rate, occurring early in the postoperative period.

Prevalence of benign microscopic hematuria among women with interstitial cystitis: implications for evaluation of genitourinary malignancy.

OBJECTIVES: To assess the prevalence of benign microscopic hematuria among a cohort of women with clinical interstitial cystitis (IC). METHODS: A total of 100 women were prospectively assessed for microscopic hematuria with postvoid sterile catheterization. The evaluation for all patients included urine culture, potassium sensitivity test (PST), cystoscopy with hydrodistension under general anesthesia, and symptom assessment with the Pelvic Pain and Urgency/Frequency (PUF) questionnaire. RESULTS: The mean age +/- SD was 37 +/- 15 years, with no difference noted in those with or without microscopic hematuria (P = 0.71). Microscopic hematuria was present in 24 (24%) of the 100 women. No patient had gross hematuria, positive urine culture, or cystoscopic findings suspicious for malignancy. The mean PUF score was 17 +/- 6. The PST was positive in 92 (92%) of 100 women, and 8 patients had only cystoscopic findings diagnostic of IC. The likelihood of a positive PST or positive cystoscopic findings among patients with microscopic hematuria was similar to that of patients without microscopic hematuria. The PST results correlated with the cystoscopic findings (P < 0.001). Of 36 patients with positive cystoscopic findings, 28 (78%) had a positive PST, and 28 (30%) of 92 with a positive PST had positive cystoscopy findings. CONCLUSIONS: In this cohort of women with IC, the prevalence of benign microscopic hematuria was 24%. These data suggest that in women at low risk of genitourinary malignancy who have clinical IC, microscopic hematuria may be an incidental finding.

Infected abdominal sacrocolpopexies: diagnosis and treatment.

The abdominal sacrocolpopexy is an excellent procedure to surgically treat vaginal vault prolapse. A synthetic graft is often used to support the vaginal apex, but has the potential to become infected or erode, requiring its removal or revision. The purpose of this paper is to report our experience in the management of patients with infected synthetic grafts after abdominal sacrocolpopexy. A review of the patient databases from three specialty gynecology centers was performed from March 1996 to June 2002. Only patients with an infected graft after an abdominal sacrocolpopexy were included in the study; patients with either suture or graft erosion responding to conservative treatment were excluded. Twenty-two women, ages 37-73 years, developed infection of the synthetic graft after an abdominal sacrocolpopexy (1-60 months after their initial surgery, mean 8.8 months). The infected materials included polytetrafluoroethylene (PTFE, Goretex, n =15) and polypropylene (n=7). Nine of the 15 PTFE meshes and four of the seven polypropylene meshes were placed at the time of a contaminated case (abdominal hysterectomy [n=12], colon resection [n=1]). Eighteen (82%) of the infected grafts involved braided permanent suture to attach the graft to the vaginal wall, monofilament/non-braided permanent suture was used in three patients, and suture type could not be determined in one. All graft removals were attempted vaginally, and this was successful in 16 cases (73%). Two patients experienced significant bleeding: the first patient required an emergency laparotomy and the second patient's bleeding was controlled with packing. A rectovaginal fistula occurred 3 weeks postoperatively in one patient. Synthetic graft infection should be considered as the differential diagnosis in a patient who has undergone an abdominal sacrocolpopexy. Transvaginal removal is preferred, but is fraught with potentially serious complications. The use of braided permanent sutures to affix the graft to the vagina may be associated with mesh infections.

Mini-incisional Burch urethropexy: a less invasive method to accomplish a time-tested procedure for treatment of genuine stress incontinence.

The purpose of this study was to evaluate the feasibility, safety and efficacy of performing the Burch urethropexy (BU) and the abdominal paravaginal repair (APR) through a 1.5-2.5 in suprapubic incision. A prospective clinical study was undertaken by four urogynecologists. Seventy-three patients, each with a urodynamic and clinical diagnosis of genuine stress incontinence, underwent a BU procedure, with 33 of the 73 having concomitant APR through the same incision. The duration of surgery and any complications were recorded. Postoperative outcome tests included subjective incontinence questionnaire, cough stress testing, pad testing, measurement of residual volumes, and analgesia requirements. The BU procedure was accomplished in 72 of 73 patients, with 1 requiring conversion to a 5 in incision. The mean operative time was 64.6 +/-21.9 (SD) min. Intraoperatively, 1 patient was noted to have a suture in the bladder. All patient having only a BU (40) went home on the day of surgery or the first postoperative day, and all patients with BU and APR went home within 2 days. All but 1 patient met the criteria for catheter removal within 7 days, with 1 patient suffering obstructive voiding. At a mean follow-up of 9 months, cough stress test and questionnaire demonstrated complete cure in 70 of 72 patients tested. Pad testing confirmed cure in all of the 46 patients who consented to the test. We conclude that the standard Burch procedure and paravaginal repair can be accomplished safely and with excellent short-term efficacy through a 1.5-2.5 in incision.

Abnormal spinal curvature and its relationship to pelvic organ prolapse.

OBJECTIVE: Intra-abdominal vector forces have been implicated in the development of genital prolapse. Because the normal spinal curvature appears to protect the pelvic cavity from direct upper abdominal forces, variations in spinal curvature may alter these vector forces and possibly potentiate the development of pelvic organ prolapse. This study was undertaken to evaluate the relationship of spinal curvature and pelvic organ prolapse, specifically, the loss of lumbar lordosis or pronounced thoracic kyphosis. STUDY DESIGN: A total of 363 patients referred for various complaints of urinary incontinence or pelvic organ prolapse were included in this multicenter, prospective, case-control study. All patients underwent a detailed history with site-specific examinations; pelvic organ prolapse was quantitatively assessed according to the POPQ (pelvic organ prolapse quantitation) staging system. Spinal curvature was measured with a flexi-curve malleable rod when patients were in a fully erect position. Spinal curvature was then transferred to graph paper by tracing the flexi-curve. Thoracic and lumbar curvatures were determined by measuring thoracic and lumbar lengths and widths, respectively. RESULTS: Ninety-two patients had abnormal spinal curvature according to the study criteria. Complete loss of lumbar lordosis was found in 69 patients. Of the 92 patients with an abnormal curvature, 84 currently had or previously had pelvic organ prolapse (sensitivity, 91%). When compared with patients with a normal curvature, patients with an abnormal spinal curvature were 3. 2 times more likely to have development of pelvic organ prolapse (odds ratio, 3.18; 95% confidence interval, 1.46 to 6.93; P =.002). There was no difference in the number of vaginal deliveries, weight of largest vaginally delivered infant, or body mass index. Only 11% (8/72) of patients with stage 0 prolapse had an abnormal spinal curvature, which increased to 30% (28/99) in patients with stage III prolapse (P =.042). CONCLUSION: An abnormal change in spinal curvature, specifically, a loss of lumbar lordosis, appears to be a significant risk factor in the development of pelvic organ prolapse.

Nephrotoxicity of high-dose ifosfamide/carboplatin/etoposide in adults undergoing autologous stem cell transplantation.

The objective of this study was to evaluate nephrotoxicity in adult patients treated with high-dose ifosfamide, carboplatin, and etoposide followed by autologous stem cell transplantation. We conducted a retrospective analysis of clinical and laboratory data from 131 patients with various malignancies who received treatment with escalating doses of ifosfamide, carboplatin, and etoposide followed by autologous stem cell transplantation as part of a phase I/II therapeutic trial. Abnormalities in glomerular filtration were evaluated by measuring peak creatinine levels and tubular dysfunction by the lowest recorded serum levels of potassium, magnesium, and bicarbonate, at different time periods after administration of ifosfamide, carboplatin, and etoposide, and after autologous stem cell transplantation. For the entire group of 131 patients, peak creatinine levels were > 1.5 mg/dL but < 3.0 mg/dL in 37% and levels were > 3.0 mg/dL in 11% at some time during their hospital stay. At the time of discharge, creatinine levels were 1.6 mg/dL to 3.0 mg/dL in 25% of patients and were > 3 mg/dL in 5%. Immediately after high-dose therapy, peak creatinine levels were significantly higher in patients receiving higher doses of ifosfamide compared to those receiving lower doses (P < 0.00001) and those receiving intermediate doses (P < 0.005). There was a dramatic decrease in serum bicarbonate, potassium, and magnesium levels immediately after chemotherapy, and they remained significantly decreased throughout the patient's hospital stay, despite massive replacement efforts (P ranging between < 0.008 and < 0.001). This is the largest adult population study documenting the incidence and severity of ifosfamide/carboplatin/etoposide-associated acute nephrotoxicity. Renal dysfunction was dose related and reversible in the majority of patients.

The prevalence of urinary incontinence or prolapse among white and Hispanic women.

OBJECTIVE: Our purpose was to study the distribution of symptoms and disorders of urinary incontinence or prolapse among white and Hispanic women. STUDY DESIGN: Data were collected for all new patients referred to the urogynecology clinic over a 2-year period. One hundred twenty-one Hispanic and 50 white women consecutively referred to the urogynecology clinic as new patients over 2 years were included in the study. All patients underwent a detailed history and physical examination and multichannel urodynamic studies. Differences between the two groups were analyzed for significant differences by use of demographic data, presenting symptoms, urodynamic profiles, and final diagnosis or disorder. RESULTS: The symptoms of stress, urge, or mixed incontinence and prolapse were noted in 26%, 18%, 30%, and 14% of white women, respectively, compared with 41%, 9%, 21%, and 26% of Hispanic women (p=0.019). The diagnosis of genuine stress incontinence, motor urge incontinence, mixed incontinence, and pelvic organ prolapse without incontinence was made, respectively, in 16%, 44%, 6%, and 18% of white women versus 30%, 27%, 5%, and 18% of Hispanic women (p=0.33). The nondiagnostic rate after a complete evaluation for both groups was 10%. Hispanic women were of significantly higher gravidity (5.6 vs 3.8, p=0.001) and parity (4.7 vs 3.0, p=0.0006) than white women but were of comparable age. Medical problems and medications were too infrequent to allow meaningful comparison. White women were much more likely to have undergone a hysterectomy (36% vs 11.5%, p=0.0004, 95% confidence interval 1.8 to 10.3). CONCLUSION: Although the distribution of presenting symptoms of incontinence differs between Hispanic and white women, the final diagnosis after a complete urogynecologic evaluation was similar. Therefore presenting complaints in patients of different ethnic groups appears to be a poor predictor of the type of incontinence. Hispanic women were of higher gravidity and parity than white women were, but white women were more likely to have undergone a hysterectomy. Because the power of this study was limited by the 50 white women, larger prospective and longitudinal studies are needed to determine the significance of possible difference in etiologic factors.

Modification of the Miya hook in vaginal colpopexy.

OBJECTIVE: To evaluate a modification of the Miya hook in performing vaginal sacrospinous ligament fixation. STUDY DESIGN: The modification was performed in over 50 patients. It involves placing the needle through the ligament unloaded; then the hook is back-threaded with the appropriate suture. The hook is then withdrawn, bringing the suture with it. RESULTS: There were no complications as a result of this modification. The technique was faster, used fewer instruments and obviated fraying of the suture. It could also be adapted when retrieving the suture when the classic technique proved difficult. CONCLUSION: The ease of this modification should promote the use of this instrument in performing vaginal sacrospinous ligament fixation.

Angiogenesis in uterine cervical squamous cell carcinoma.

This study tested the hypothesis that increased angiogenesis in squamous cell carcinoma of the cervix is an indicator of poor prognosis. We retrospectively studied 70 cases and related the microvessel count to stage and follow-up. We performed immunohistochemical staining for Factor VIII and counted the number of microvessels in a 400x field in the area of greatest density of vessels. The mean vessel count in stage I was 18.3 +/- 5.4 (26 cases), in stage II 18.0 +/- 6.8 (21 cases), in stage III 17.9 +/- 3.9 (18 cases), and in stage IV 22.2 +/- 13.6 (five cases). We found no correlation between the mean vessel count and stage (p < 0.85) or between mean vessel count and disease status on an average follow-up of 21 months (p < 0.65). With a power of approximately 70%, this study excludes the hypothesis that an increased density of microvessels is associated with a worsened prognosis in cervical squamous cell carcinoma.

Recent advances: parenteral nutrition support.

Even though there is an abundance of research related to the clinical and physiologic effects of parenteral nutrition and specific nutritional substrates, few new products have been released for clinical use. This review illustrates some of the directions being taken in the future development of parenteral nutrition products and some new perspectives related to the current effects (or lack of effects) of TPN. When considering the individual effects of specific nutrient substrates (arginine, glutamine, LCTs, MCTs, SCFAs) as reviewed here, it becomes apparent that the infusion of parenteral nutrition has the potential to produce a variety of metabolic responses that could be both beneficial and harmful. These effects depend on the type and quantity of substance infused as well as the disease and clinical condition of the patient. This also is true for those substances (GH, IGF-1) being evaluated to direct the effects of TPN infusions in a manner that improves protein accretion and supports the immunologic response of the body. At best, these investigations are producing a great amount of new and more specific information about the metabolic response to illness and the effects of TPN and individual substrate on that response.

Drug use evaluation approach to monitoring use of total parenteral nutrition: a review of criteria for use in cancer patients.

Monitoring of total parenteral nutrition (TPN) by drug use evaluation appears to be a reasonable approach to characterizing use of parenteral nutrition within an institution. Development of specific criteria for use of TPN may be difficult because of the broad nature of published guidelines. Criteria for use of TPN in tumor-bearing patients is controversial. Results from recent investigations conflict with previous generally accepted guidelines for providing TPN in cancer patients. This article reviews published guidelines for use of TPN as well as application of these guidelines for drug use evaluation. Criteria for use of TPN and results of a subsequent drug use evaluation in a cancer institution are presented.

Nonfluorescent erythrasma of the vulva.

BACKGROUND: Erythrasma is an uncommon vulvar infection, best diagnosed by its fluorescence under the Wood lamp. This report shows that despite a negative Wood lamp examination, the diagnosis can be made histologically. CASE: A 42-year-old woman was referred to our clinic with a persistent candidal infection. Evaluation included a Wood lamp examination, wet mount, and potassium hydroxide test of the affected skin, all of which were negative. A biopsy of the area demonstrated rods and filamentous organisms in the keratotic layer consistent with a Corynebacterium minutissimum infection. The patient was diagnosed as having erythrasma, and she responded to oral erythromycin. CONCLUSION: Persistent vulvar diseases may be caused by erythrasma despite a negative Wood lamp examination. The diagnosis can be made by biopsy of the lesion.