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Background: Decisional regret (DR) has previously been applied to other urologic issues (hypospadias, prostate cancer). The present study seeks to evaluate certain patient factors that directly correlate to high DR scores in anti-incontinence procedures. Methods: Medical records for 119 patients undergoing anti-incontinence procedures between 2009 and 2020 were retrospectively reviewed. Forty-one patients were accessible for telephone follow-up and provided a Decisional Regret Scale (DRS) questionnaire. If patients had both a sling and an artificial urinary sphincter (AUS) placed, questionnaires were administered for each. DRS score was quantified in accordance with prior literature, with scores ranging 0-100. We subdivided patients based on demographics and surgical data, correlating this with DRS score. Results: In 41 patients, 46 procedures (13 slings, 33 AUS) were performed. Thirty-nine (95.1%) men underwent robotic-assisted laparoscopic prostatectomy, and 11 (26.8%) men reported prior pelvic radiation. Post-procedural continence, irrespective of procedure, yielded an average 2±1.56 pads per day (PPD). Mean DRS score across the cohort was 29.78. DRS score was subdivided into mild, moderate, and severe, with majority noting "none to mild" regret (63%), 15.2% reporting moderate and 21.7% severe. Predictors of higher regret included history of radiation (P=0.056), choice of anti-incontinence procedure (P=0.011), and need for surgical revision (P=0.00042). DR was unrelated to race, complete continence, and time to follow-up. Conclusions: DRS has recently been applied to anti-incontinence procedures for male stress incontinence; our study highlights novel findings not previously assessed. Majority of men had minimal regret with a subset that had significant regret-history of radiation, multiple revisions/explant, and those who elected for sling upfront. These results highlight the importance of patient selection and pre-operative counselling.
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PURPOSE: To report long-term results and patient reported outcomes of staged anterior urethroplasties, and isolate risk factors for recurrence. METHODS: We reviewed urethroplasty database for all patients who underwent staged urethroplasty from 2000 to 2017. Follow-up included a cystoscopy 4 months after their 2nd stage to assess early success, and then annual follow-up thereafter with post-void residual and symptom assessment. Stricture characteristics, etiology and graft type were analyzed with regards to success. RESULTS: Forty-nine patients were eligible for inclusion. The median stricture length was 7 cm (3-17 cm). The early success rate demonstrated by cystoscopy at 4 months was 100%. Long-term success was 96.4% in buccal graft (BMG) only patients; however, long-term success fell considerably to 53% in patients requiring any use split thickness skin graft (STSG) in the first stage. Median follow up time was 57 months (6-240 months). On analysis, age, increased stricture length and especially the use of STSG all appeared to be associated with late recurrence. The recurrence group had longer stricture length and were more likely to be panurethral. All recurrences occurred after the initial 4-month cystoscopy with a median time to recurrence of 78 months. CONCLUSION: Staged repairs that are amenable to BMG-only repairs have high long-term success rates. Increasing stricture length and the addition of split-thickness skin graft were associated with lower success rate in staged urethral reconstruction. Patients requiring staged repairs often experience recurrence in a very delayed fashion reinforcing the need for close, long-term follow up.
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Mucosa Bucal/trasplante , Procedimientos de Cirugía Plástica/métodos , Trasplante de Piel/métodos , Estrechez Uretral/cirugía , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Adolescente , Adulto , Anciano , Balanitis Xerótica Obliterante/complicaciones , Estudios de Seguimiento , Humanos , Hipospadias/complicaciones , Masculino , Persona de Mediana Edad , Recurrencia , Factores de Riesgo , Estrechez Uretral/complicaciones , Adulto JovenRESUMEN
OBJECTIVE: To present a novel surgical approach to performing bulbar urethroplasty and to assess its initial outcomes and safety. MATERIALS AND METHODS: From January 2016 to March 2019, anastomotic urethroplasty without full mobilization and dissection of corpus spongiosum dorsal semicircumference was performed in 8 males with bulbar strictures by a single surgeon. Patients were given uroflowmetry, urethrography, and International Index of Erectile Function (IIEF) questionnaires at their 3- and 12- month follow-up visits postoperatively. RESULTS: Mean stricture length was 2.3 cm (±0.59 cm) and mean surgery time was 131 minutes. No early or late postoperative complications were observed. Median maximum flow rate (Qmax) assessed 3 months after surgery was 22.35 mL/sec (±6.4 mL/sec). There were no significant changes in median IIEF score postoperatively (preoperative IIEFâ¯=â¯18.4 vs postoperative IIEFâ¯=â¯19.6; P >.05). During patients' 1-year observation period, no signs of constriction in the anastomosis were revealed with urethrography. One of the limitations of this technique is a necessity of more precise corpus spongiosum preparation to ensure perioperative hemostasis and good visualization. This outcome may, however, require additional time and increased blood loss during a surgeon's learning curve of the procedure. CONCLUSION: The initial experience of this minimally invasive urethroplasty technique showed high efficiency and no early stricture recurrences. However, the clinical significance of additional preservation of innervation and blood supply, the potential to further optimize this technique's functional outcomes, and applicability of this technique in patients with spongiofibrosis requires further investigation. Our results make it possible to consider this technique as a possible alternative to classic anastomotic urethroplasty.
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Anastomosis Quirúrgica , Uretra/cirugía , Estrechez Uretral/cirugía , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Adulto , Anciano , Pérdida de Sangre Quirúrgica , Humanos , Masculino , Persona de Mediana Edad , Tempo OperativoRESUMEN
The most dreaded complication of penile prosthesis (PP) implantation is device infection. We sought to assess whether inadequate cleaning and sterilization of the reusable Furlow inserter may represent one of the last etiologies of infection in PP patients. We performed a prospective analysis of cultures of the Furlow inserter used for PP surgeries from seven centers between May 1st and June 30th, 2019. Once the Furlow was received for surgery, the surgical team inspected the device for assembly status (disassembled or not) and the presence of visible stains, pieces of tissue or discoloration on either the interior of the barrel or the plunger. Swab aerobic and anaerobic bacterial and fungal cultures were then obtained from the internal component, after removal from the external component if assembled, and after introduction and immediate removal from the external component if disassembled. A total of 83 Furlow devices were cultured. Median age of surgical instrument was 4 years (2-10 years). Methods of sterilization included autoclave, wet autoclave, steam, and Sterad. Median time from sterilization was 3 days (1-22). On initial presentation, 79 devices were disassembled (95.1%) and 4 devices were still assembled (4.9%). Three external components were discolored (3.6%), while internal components demonstrated two stains (2.4%) indicative of improper cleaning which were thought to be residual blood products. Overall, 2/83 (2.4%) devices revealed positive swab cultures for Staphylococcus epidermidis. Swab cultures were negative for fungi and anaerobic bacteria. This patient cohort will continue to be followed to see if device infection occurs but it is unlikely to be meaningful since contaminated Furlows were discarded. Improper cleaning and/or sterilization of the Furlow Insertion Instrument may represent a source of infection for patients undergoing PP implantation.
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Enfermedades del Pene , Implantación de Pene , Prótesis de Pene , Preescolar , Humanos , Masculino , Pene , Estudios ProspectivosRESUMEN
The diagnosis of urethral stricture disease is often made when a man with obstructive voiding symptoms undergoes flexible cystoscopy (urethroscopy). However, a more complete and definitive diagnosis is then achieved when the urethra is subsequently evaluated with a retrograde urethrogram, and in many cases, a voiding cystourethrogram (VCUG). In situations where there is stricture disease involving the meatus or fossa navicularis that prevents the passage of adult flexible cystoscope, other testing appropriate in these cases include distal urethral calibration using bougie-a-boules and possibly the advancement of a pediatric cystoscope. It is only after the exact location and length and severity of the stricture is assessed that patients can be properly advised of all options before decision-making and the implementation of a treatment plan. This section will review the evaluation of the male urethra.
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Estrechez Uretral , Adulto , Niño , Constricción Patológica , Cistoscopios , Cistoscopía , Humanos , Masculino , Uretra/diagnóstico por imagen , Estrechez Uretral/diagnóstico por imagen , Estrechez Uretral/cirugíaRESUMEN
This section aims to review general principles of endoscopic management of urethral stricture disease and posterior urethral stenosis, with a special focus on the indications for treatment and technical aspects of urethral dilation and internal incision.
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Contractura , Estrechez Uretral , Endoscopía , Humanos , Masculino , Uretra/diagnóstico por imagen , Uretra/cirugía , Estrechez Uretral/cirugía , Vejiga Urinaria/diagnóstico por imagen , Vejiga Urinaria/cirugíaRESUMEN
OBJECTIVE: To report success and patient reported urinary and sexual outcomes of patients who underwent anastomotic urethroplasty and dorsal buccal onlay urethroplasty. MATERIALS AND METHODS: Patients who underwent primary transecting anastomotic or dorsal buccal onlay urethroplasty for bulbar strictures at our institution between 1998 and 2015 were analyzed. Patients who had a prior urethroplasty, involvement of a different portion of the urethra, or a diagnosis of lichen sclerosis (LS) or hypospadias were excluded. Outcomes were assessed by cystoscopy at 4 months, validated questionnaires assessing urinary, erectile, and ejaculatory function at the time of their most recent assessment. RESULTS: A total of 40 and 139 patients were included in the dorsal buccal and anastomotic groups, respectively. Wide patency at 4-month cystoscopy was 97.5% and 100% (P= .06) and the long-term success was 95% and 99.3% (P= .06) with a mean follow-up of 51.4 and 63.3 months. Patient reported outcomes were similar with 2 exceptions: postvoid dribbling was reported more often in the onlay group (28.1% vs 8.3%, P< .0001), and tethering with erections in the anastomotic group (23.4% vs 3.1%, P= .008). Ninety-eight percent of patients in the anastomotic group and 91% in the dorsal buccal onlay group would choose their surgery again (P= .07). CONCLUSION: Both anastomotic urethroplasty and dorsal onlay graft are associated with high success with comparable satisfaction. Patient reported outcome measures were similar regardless of approach, despite inherent differences in stricture length. Our data indicates that anastomotic urethroplasty should not be avoided due to concerns of sexual side effects.
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Eyaculación , Erección Peniana , Uretra/cirugía , Estrechez Uretral/cirugía , Micción , Procedimientos Quirúrgicos Urológicos Masculinos , Adulto , Anastomosis Quirúrgica , Humanos , Masculino , Estudios Retrospectivos , Resultado del Tratamiento , Procedimientos Quirúrgicos Urológicos Masculinos/métodosRESUMEN
INTRODUCTION: The objective of genital enlargement surgery is to increase length and/or girth for cosmetic reasons; however, newer techniques have been recently reported to be associated with only minor complications in a small percentage of patients. AIM: We aim to report the severe complications of penile augmentation surgery seen at a referral center and describe their subsequent management. METHODS: Institutional review board approval was obtained. We reviewed our prospectively collected database for all patients who presented with complications of genital enlargement surgery from 2002-2016. MAIN OUTCOME MEASURE: Interventions following complications of genital enlargement surgery. RESULTS: 11 Patients were identified. Mean age was 47 (21-77) years. Prior procedures included subcutaneous injection of silicone outside a medical setting, girth enhancement procedures involving the subcutaneous placement or injection of substances including fat, other substances, or subcutaneous silicone implants. All patients who underwent subcutaneous penile implant underwent removal prior to presentation. Adverse changes included sexually disabling penile deformity and severe shortening, curvature, edema, subcutaneous masses, infection, non-healing wounds, and sexual dysfunction. 10 patients underwent corrective surgery, with 2 requiring multiple procedures and 3 requiring split-thickness skin grafting. All 10 patients had an improved cosmetic appearance and those who had disabling shortening had significantly improved functional length. CLINICAL IMPLICATIONS: Report of such adverse events should assist in appropriate perioperative counseling prior to genital enhancement surgery. STRENGTH & LIMITATIONS: Few reports of debilitating complications of penile enlargement exist in literature. However, without knowing the overall number of procedures performed, the true complication incidence is not known. CONCLUSION: Penile and scrotal enhancement surgery can be associated with major disabling complications, leading to deformity and functional compromise in men with prior normal anatomy and function. Patients should be aware of these risks. Furr J, Hebert K, Wisenbaugh E, et al. Complications of Genital Enlargement Surgery. J Sex Med 2018;15:1811-1817.
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Enfermedades del Pene/etiología , Implantación de Pene/efectos adversos , Prótesis de Pene/efectos adversos , Complicaciones Posoperatorias/etiología , Adulto , Anciano , Humanos , Masculino , Persona de Mediana Edad , Implantación de Pene/métodos , Pene/cirugía , Siliconas/efectos adversos , Procedimientos Quirúrgicos Urogenitales/efectos adversosRESUMEN
PURPOSE: Malone antegrade continence enema has been a successful and widely used procedure for achieving fecal continence in children. We present data on the previously uninvestigated issue of patient and caregiver regret following surgery for intractable constipation and fecal incontinence. MATERIALS AND METHODS: We reviewed all patients undergoing antegrade continence enema or cecostomy creation at a single institution between 2006 and 2016. Patients and caregivers were assessed for decisional regret using the Decisional Regret Scale. Results were correlated with demographics, surgical outcomes and complications. RESULTS: A total of 81 responses (49 caregivers and 32 patients) were obtained. Mean followup was 49 months. Decisional regret was noted in 43 subjects (53%), including mild regret in 38 (47%) and moderate to severe regret in 5 (6%). No statistical difference in regret was noted based on gender, complications or performance of concomitant procedures. On regression analysis incontinence was strongly associated with decisional regret (OR 4.4, 95% CI 1.1-18.1, p <0.001) and regret increased as age at surgery increased, particularly when patients were operated on at age 13 to 15 years (OR 2.6, 95% CI 1.0-6.4 for age 13 years; OR 2.9, 95% CI 1.1-7.8 for age 14 years; OR 3.1, 95% CI 1.1-8.8 for age 15 years). CONCLUSIONS: This is the first known study describing decisional regret following surgery for fecal incontinence. Surgical factors aimed at achieving continence may be effective in decreasing postoperative regret. The finding of increased regret in teenage patients compared to younger children should be shared with families since it may impact the age at which surgery is pursued.
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Cuidadores/psicología , Cecostomía/efectos adversos , Emociones , Incontinencia Fecal/cirugía , Participación del Paciente/psicología , Complicaciones Posoperatorias/epidemiología , Adolescente , Factores de Edad , Apéndice/cirugía , Cateterismo/efectos adversos , Cateterismo/métodos , Cecostomía/métodos , Niño , Toma de Decisiones Clínicas/métodos , Estreñimiento/etiología , Estreñimiento/cirugía , Incontinencia Fecal/etiología , Femenino , Estudios de Seguimiento , Humanos , Laparoscopía/efectos adversos , Laparoscopía/métodos , Masculino , Intestino Neurogénico/complicaciones , Intestino Neurogénico/cirugía , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
We report a rare case of isolated penile fracture in a prepubescent male caused by an accidental fall. The patient presented with swelling and ecchymosis on the base of the penis and along the penile shaft. A flexible cystoscopy was performed, which did not reveal any concomitant urethral injury. The penis was degloved and the corporal tear was closed with absorbable suture. Due to the location of the injury, ventral mobilization of the urethra was required. The pathophysiology of penile fracture as well as the diagnosis and management of this rare injury are discussed in this report.
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Accidentes por Caídas , Enfermedades del Pene/cirugía , Pene/lesiones , Procedimientos de Cirugía Plástica/métodos , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Heridas y Lesiones/complicaciones , Niño , Cistoscopía , Humanos , Masculino , Enfermedades del Pene/diagnóstico , Enfermedades del Pene/etiología , Pene/diagnóstico por imagen , Pene/cirugía , Rotura , Ultrasonografía , Uretra/diagnóstico por imagen , Uretra/lesiones , Uretra/cirugía , Heridas y Lesiones/diagnóstico , Heridas y Lesiones/cirugíaRESUMEN
INTRODUCTION: Advances in vasectomy technique have minimized patient discomfort; however fear of pain remains a primary concern. The objective is to determine how the anticipation of pain associated with vasectomy compares with patient's actual intraoperative experienced pain levels. MATERIALS AND METHODS: A cohort of patients undergoing clinic vasectomy was analyzed. Using visual analog pain scale patients were asked to rate their anticipated pain score (APS) pre-procedure and then an experienced pain score (EPS) post-procedure. Patients were also stratified by APS scores (high versus low). Changes in pain score were compared across these groups. Pain scores stratified by age, race, narcotics use, psychiatric history, and prior surgical history were also compared. RESULTS: In the 172 patients included, the average pre-op APS was 5.2 (95% CI 4.3-5.6), while post-op EPS was 2.1 (95% CI 1.8-2.4). Patients were stratified into 'high' (6-10) and 'low' (0-5) pre-op APS groups. The average drop in pain scores was found to be significantly larger in the 'high' versus the 'low' APS groups (4.66 versus 1.65 p < 0.001). No statistical difference was noted in the change in pain scores based on age, race, prior surgical history, chronic narcotics use or psychiatric history. Both groups tolerated the procedure well, with the mean EPS of 2.56 for the 'high' and 1.73 for the 'low' APS group (p < 0.05). CONCLUSIONS: The actual pain experienced by a patient is significantly lower than their anticipation of vasectomy pain, which will aid clinicians in appropriately counseling patients and minimizing pre-procedural anxiety.
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Dolor Postoperatorio , Vasectomía , Adulto , Miedo , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Adulto JovenRESUMEN
While rare, trauma and injury to the male external genitalia can result in significant consequences regarding function, appearance, psychological effects, and overall quality of life. Due to the relative paucity of literature regarding male external genitalia injuries, few standardized protocols exist. This review aims to outline common clinical causes of male external genitalia injuries by both anatomic location and etiology. Initial stabilization, long-term reconstruction, and coverage options are discussed in detail. Outcomes of complex grafts have favorable success rates of 90-100% in the hands of experienced surgeons. Outcomes of penile, testicular trauma also have favorable outcomes when managed appropriately. Attempts at reconstruction after initial injury stabilization should be undertaken at high-volume centers where a multidisciplinary approach can be employed. This manuscript will be an excellent reference and source that can provide direction for evaluation and management of these complex presentations.
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Gangrena de Fournier/terapia , Enfermedades de los Genitales Masculinos/terapia , Genitales Masculinos/lesiones , Amputación Traumática/terapia , Quemaduras/terapia , Gangrena de Fournier/complicaciones , Enfermedades de los Genitales Masculinos/microbiología , Humanos , Masculino , Pene/lesiones , Piel/lesiones , Trasplante de Piel , Cordón Espermático/lesiones , Tejido Subcutáneo/lesiones , Colgajos Quirúrgicos , Testículo/lesiones , Heridas y Lesiones/etiología , Heridas y Lesiones/terapiaRESUMEN
OBJECTIVE: To describe clinical management of Fournier's gangrene and to characterize predictive factors associated with inpatient mortality and extended hospital stay. MATERIALS AND METHODS: The National Inpatient Sample was queried from 2004 to 2012 based on the International Classification of Diseases, Ninth Revision, Clinical Modification procedural and diagnosis codes. Patients admitted for Fournier's gangrene who underwent debridement were selected. Multivariate logistic regression analysis was performed to identify predictors of inpatient mortality and extended hospital stay. RESULTS: A total of 9249 patients were identified for a weighted estimate of 43,146 cases. Inpatient mortality was 4.7%. The median length of stay was 9 days (interquartile range 5-17 days). The most common procedure in addition to debridement was a complex closure (8.82%), followed by suprapubic tube placement (5.70%) and fecal diversion (4.68%). Increasing age, yearly hospital volume >10 cases, and Medicaid insurance status were associated with increased risk of mortality. Increasing age, teaching hospital status, increasing number of comorbidities, and Medicaid as a payor were predictive of increased hospital stay. Suprapubic tube placement (odds ratio [OR] 2.8 [95% confidence interval {CI} 1.92-4.07], P ≤ .001), fecal diversion (OR 11.1 [95% CI 6.20-19.7], P ≤ .001), and complex wound closure (OR 4.89 [95% CI 3.97-6.89], P ≤ .001) were also predictive of increased length of stay. CONCLUSION: Identifiable patient and hospital characteristics are predictive of both mortality and length of stay in the management of Fournier's gangrene. Overall inpatient mortality appears lower than what has been reported in the majority of prior reports. The strongest predictor for increased length of stay is the need for complex wound closure, and urinary or fecal diversion.
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Procedimientos Quirúrgicos Ambulatorios/tendencias , Gangrena de Fournier/mortalidad , Gangrena de Fournier/cirugía , Tiempo de Internación , Adulto , Anciano , Anciano de 80 o más Años , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios RetrospectivosRESUMEN
Endodermal sinus (yolk sac) tumors (ESTs) are rare neoplasms that most commonly arise in the ovaries or testis. Only six cases of prostatic ESTs have been reported in the literature. We report a case of prostatic EST, the first case in which the patient had a history of previous testis cancer. Treatment included cisplatin-based chemotherapy and radical prostatectomy. Previous cases of primary ESTs and use of cisplatin-based therapy as well as metastatic tumors to the prostate are discussed.
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Tumor del Seno Endodérmico/diagnóstico , Neoplasias de la Próstata/diagnóstico , Neoplasias Testiculares/patología , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bleomicina/uso terapéutico , Cisplatino/uso terapéutico , Supervivencia sin Enfermedad , Tumor del Seno Endodérmico/tratamiento farmacológico , Tumor del Seno Endodérmico/secundario , Tumor del Seno Endodérmico/cirugía , Etopósido/uso terapéutico , Humanos , Masculino , Metástasis de la Neoplasia , Prostatectomía , Neoplasias de la Próstata/tratamiento farmacológico , Neoplasias de la Próstata/secundario , Neoplasias de la Próstata/cirugía , Recurrencia , Procedimientos Quirúrgicos Robotizados , Resultado del Tratamiento , Vincristina/uso terapéuticoRESUMEN
Introduction. Plasmacytoid urothelial carcinoma (PUC) of the bladder is a rare histological variant of urothelial carcinoma that was recently identified. Available data on this histological variant is limited. Case Report. We report the case of a 75-year-old man with presumed history of high-grade urothelial cancer of the bladder, treated with transurethral resection and Bacille Calmette-Guérin (BCG) in 2004. Six years after treatment of the bladder cancer, the patient underwent gastrectomy for an undifferentiated carcinoma of the stomach. On followup, patient developed right ureterohydronephrosis and peritoneal carcinomatosis. Biopsy of the bladder during stent placement revealed a plasmacytoid urothelial carcinoma of the bladder. Rereadings revealed that the initial bladder and gastric malignancies were also plasmacytoid carcinoma, indicating that, the patient had since 2004, a PUC of the bladder that spread to the stomach and peritoneal cavity. Conclusion. Plasmacytoid urothelial carcinoma of the bladder is an aggressive variant of urothelial carcinoma. Based on our case and the literature review, this tumor can be misdiagnosed because of its rarity, leading to treatment delays. Both the urologist and the pathologist need to have a high index of suspicion for PUC whenever they encounter unusual clinical and/or pathological findings.
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BACKGROUND: Cancer is the second leading cause of death among women of reproductive age. Although the coincidence of pregnancy and cancer is rare and treatment may sometimes be safely delayed, the use of chemotherapeutic agents in pregnancy is sometimes unavoidable or inadvertent. METHODS: We review the literature for the use of antineoplastic agents in single-agent and combination therapy from 1951 through June 2012. We also summarize the evidence relating to teratogenicity of disorder-specific combination chemotherapy treatments for those malignancies frequently encountered in women of childbearing age. Major endpoints were called "adverse pregnancy outcomes" (APOs), to include structural anomalies (congenital malformations), functional defects, blood or electrolyte abnormalities, stillbirths, spontaneous abortions (miscarriages), and fetal, neonatal, or maternal deaths. RESULTS: The registry totals 863 cases. Rates of APOs (and congenital malformations) after any exposure were 33% (16%), 27% (8%), and 25% (6%), for first, second, and third trimesters. Among the groups of cancer drugs, antimetabolites and alkylating agents have the highest rates of APOs. Mitotic inhibitors and antibiotics seem more benign. Mixed results were observed from single-agent exposure, often because of small numbers of exposures. As a whole, the alkylating agents and antimetabolites are more harmful when given as a single agent rather than as part of a regimen. First-trimester exposure poses a more permanent risk to the fetus. CONCLUSIONS: Systematic ascertainment of women early in pregnancy, preferably in a population base, is needed for assessment of true risks. Long-term follow-up is needed to rule out neurobehavioral effects.