transforming-growth-factor-beta and Sexual-Dysfunction--Physiological

The aim of this study was to determine the incidence and assess specific risk factors in the postoperative development of retrograde ejaculation (RE) in men treated for degenerative lumbar disc disease at the L4-5 or L5-S1 level with stand-alone anterior interbody implants with or without recombinant human bone morphogenetic protein-2 (rhBMP-2).. Patients enrolled in 5 prospective, randomized, multicenter FDA-approved investigational device exemption studies were observed for a minimum of 2 years to assess the rate of RE. Five hundred eight men with symptomatic single-level lumbar degenerative disc disease with up to Grade 1 spondylolisthesis underwent anterior lumbar interbody surgery with stand-alone anterior implants at either L4-5 or L5-S1. All patient self-reported and physician-documented adverse events were recorded over the entire course of follow-up. In the investigational groups, 207 patients were treated with an open surgical procedure using dual paired constructs and rhBMP-2 on an absorbable collagen sponge. The control groups (n = 301) were treated with lumbar fusion cage implants and iliac crest autograft or a metal-on-metal disc arthroplasty device. Multivariate analyses of RE were performed to assess the influence of treatment (rhBMP-2), surgical approach, and treated level. Data were analyzed for each trial individually and for the data pooled from the 5 trials.. Retrograde ejaculation occurred at the highest rates in the earliest clinical trial. Of the 146 men, 6 (4.1%) developed RE postoperatively. In subsequent studies, the rates of RE ranged from 0% to 2.1%. Combining the data from the 5 trials, RE was reported in 7 (3.4%) of the 207 patients who received the rhBMP-2 treatment compared with 5 (1.7%) of the 301 patients who received the autograft or lumbar disc treatment (p = 0.242, Fisher exact test). Cases of RE were reported in 7 (1.6%) of 445 patients who underwent a retroperitoneal spinal exposure; 5 RE cases were reported in 58 patients (8.6%) who underwent a transperitoneal approach. The difference in surgical approaches was significant (p = 0.007, Fisher exact test). There was no difference in the rate of RE based on the lumbar level exposed (p = 0.739). Multivariate analyses were consistent with the conclusions from Fisher exact tests. In the initial rhBMP-2 trial, after adjusting for effects of surgical approach and treated level, the difference in RE between the treatment groups (rhBMP-2 vs autograft or disc arthroplasty) was not significant (p = 0.177); however, the difference in RE between the retroperitoneal and transperitoneal approaches was significant (p = 0.029).. In these 5 prospective randomized trials involving anterior lumbar interbody surgery, the use of rhBMP-2 was associated with a higher incidence of RE (3.4% vs 1.7%) but did not reach statistical significance. Based on surgical approach, the difference in rates of RE was statistically significant. This study reports on the outcomes of 5 prospective randomized FDA-approved investigational device exemption trials. Registration for studies became law in 2007. Four of these trials were completed before the law went into effect. The registration number for the lumbar disc arthroplasty trial is NCT00635843.

Topics: Adult; Aged; Bone Morphogenetic Protein 2; Ejaculation; Humans; Intervertebral Disc Degeneration; Lumbar Vertebrae; Male; Middle Aged; Prospective Studies; Prostheses and Implants; Recombinant Proteins; Risk Factors; Sexual Dysfunction, Physiological; Spinal Fusion; Spondylolisthesis; Transforming Growth Factor beta; Treatment Outcome

To examine the outcomes of sexual function in postmenopausal women and women with a history of breast cancer treated with endocrine therapy who were experiencing the symptoms of GSM for which they were treated with fractional microablative CO. From July 2015 to October 2016, a retrospective chart review of women who underwent fractional microablative CO. There was a statistically significant improvement in every domain of FSFI, WBFS, and FSDS-R when comparing baseline symptom scores to after treatment three symptom scores for all patients. The secondary outcome was to evaluate the differences, if any, in outcomes of sexual function between postmenopausal women and women with a history of breast cancer treated with endocrine therapy. Both groups had statistically significant improvements in many domains studied.. Fractional microablative CO

Topics: Antineoplastic Agents, Hormonal; Breast Neoplasms; Cancer Survivors; Female; Female Urogenital Diseases; HSP47 Heat-Shock Proteins; Humans; Laser Therapy; Lasers, Gas; Middle Aged; Mucous Membrane; Postmenopause; Retrospective Studies; Sexual Dysfunction, Physiological; Surveys and Questionnaires; Transforming Growth Factor beta; Treatment Outcome; Vagina

This was a prospective study evaluating the incidence of retrograde ejaculation (RE) after anterior lumbar interbody fusion (ALIF) based on laboratory analysis of semen and urine.. The purpose of this study was to investigate the incidence of RE based on quantitative semen analysis and to compare the rate with that identified using a standardized qualitative questionnaire administered by telephone.. RE is a specific sexual dysfunction in which semen passes into the bladder during ejaculation. It has long been a known possible complication of ALIF associated with injury to the superior hypogastric plexus occurring during access to the anterior lumbar spine. Although reported in multiple studies, there is no standardized assessment for RE and many studies do not describe the methods by which it was assessed. Recently, there has been increased interest in ALIF-related RE with respect to the use of recombinant human bone morphogenetic protein (rhBMP-2). However, how RE was diagnosed remains loosely defined. One possible assessment of RE is to analyze semen and urine after ejaculation.. Forty-one male patients undergoing ALIF with posterior pedicle screw instrumentation and fusion at L4-L5 and/or L5-L1 consented to participate in the study. The subjects went to a cryobank for preoperative semen and postejaculatory urine analysis. They returned to the cryobank 3 to 6 months after surgery for repeat testing. The semen analysis consisted of ejaculate volume, total sperm count, concentration, and motility, whereas the urine test reported postejaculatory voided urine for spermatozoa. Postoperatively, patients were called by the principle investigator who conducted an interview based on a standardized questionnaire (completed for 36 patients). Patients were considered to have RE based on the questionnaire if they reported less or no ejaculate fluid. These results were compared with those from the laboratory testing to evaluate the value of the questionnaire in assessing RE. rhBMP-2 was used in 21 of the cases. The incidence of RE was compared in these patients versus those in whom rhBMP-2 was not used.. Four patients (9.8%) were diagnosed with RE based on the laboratory analysis, 2 of which resolved spontaneously. Based on the questionnaire, 15 (41.7%) patients reported having RE, including the 4 that were confirmed by laboratory testing. Of the 21 patients treated with rhBMP-2, 2 (9.5%) were diagnosed with RE, 1 of which resolved. Of the 20 patients treated without rhBMP-2, 2 (10.0%) had RE, 1 of which resolved.. This study suggests that use of a questionnaire tends to overestimate the incidence of RE as compared with the quantitative semen and urine analysis. Contrary to recent studies using retrospective qualitative review, in this small group with quantitative analysis, use of rhBMP-2 was not related to an increased incidence of RE, with a rate of approximately 10% in both patients receiving, and those not receiving, rhBMP-2. Further study of a larger group using preoperative semen and urine analysis, postoperative standard questionnaire and postoperative semen analysis should be pursued to further investigate the occurrence of RE and to possibly assist in developing and validating a questionnaire for RE assessment.

Topics: Adult; Bone Morphogenetic Protein 2; Ejaculation; Humans; Lumbar Vertebrae; Male; Middle Aged; Postoperative Complications; Prospective Studies; Recombinant Proteins; Reproducibility of Results; Semen Analysis; Sexual Dysfunction, Physiological; Sperm Count; Sperm Motility; Spinal Fusion; Surveys and Questionnaires; Time Factors; Transforming Growth Factor beta; Young Adult

Topics: Bone Morphogenetic Protein 2; Ejaculation; Humans; Intervertebral Disc Degeneration; Lumbar Vertebrae; Male; Recombinant Proteins; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta

Retrograde ejaculation (RE) is a complication of anterior lumbar interbody fusion (ALIF) techniques. Most commonly, this results from mechanical or inflammatory injury to the superior hypogastric plexus near the aortic bifurcation. Bone morphogenetic protein-2 (BMP-2) has been used in spinal fusions and has been associated with inflammatory and neuroinflammatory adverse reactions, which may contribute to RE development after anterior lumbar surgery.. While controlling for anterior approach technique, we compared the incidence of RE with and without rhBMP-2 exposure, in large, matched cohorts of patients after ALIF.. Retrospective analysis of 10 years of prospectively gathered outcomes data on consecutive-patient cohorts having the same anterior exposure technique for ALIF with and without rhBMP-2 use.. All male patients without baseline sexual incapacity and having ALIF for lumbar spondylosis or spondylolisthesis of the lowest one or two lumbar levels with and without rhBMP-2, from 2002 through 2011.. Diagnosis of RE as a new finding after ALIF compared against BMP-2 exposure, comorbid conditions, and other urological complications after ALIF surgery.. From the comprehensive surgical database at a high volume, university practice, male subjects having ALIF at one (L5/S1) or two levels (L4/5, L5/S1) from 2002 to 2011 were identified. Baseline comorbid factors, postoperative urinary catheter/retention events, and RE events were recorded and comparative incidence compared.. There were four consecutive-patient cohorts identified: one before rhBMP-2 use was adopted (n=174), two cohorts in which BMP-2 use was routine (n=88 and n=151), and one final cohort after BMP-2 use was discontinued from routine use (n=59). The cohorts with and without BMP-2 exposure were closely comparable for age, approach, levels of surgery, comorbid factors affecting RE. Of 239 patients with ALIF and exposure to BMP-2, RE was diagnosed in 15 subjects (6.3%), compared with an RE diagnosis rate of two of 233 control patients without BMP-2 exposure (0.9%; p=.0012). Urinary retention after bladder catheter removal was also more frequently observed in patients exposed to BMP-2 (9.7%) compared with control patients (4.6%; p=.043). Of the baseline comorbid factors, medical or surgical treatment for prostatic hypertrophy disease was associated with an increased risk of RE in the BMP-2 patients (p=.034).. This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2 and an open anterior approach to the spine. This effect may be associated with an increased risk of postoperative urinary retention after BMP-2 exposure. The magnitude of the RE effect may be increased with concomitant prostatic disease treatments.

Topics: Adult; Aged; Bone Morphogenetic Protein 2; Ejaculation; Humans; Lumbar Vertebrae; Male; Middle Aged; Postoperative Complications; Recombinant Proteins; Retrospective Studies; Sexual Dysfunction, Physiological; Spinal Fusion; Spondylolisthesis; Spondylosis; Transforming Growth Factor beta; Young Adult

Topics: Bone Morphogenetic Protein 2; Ejaculation; Humans; Male; Postoperative Complications; Recombinant Proteins; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta

Topics: Bone Morphogenetic Protein 2; Humans; Male; Postoperative Complications; Recombinant Proteins; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta

The commercially available growth factor recombinant bone morphogenic protein-2 (rhBMP-2) used in spinal fusion has been associated with numerous adverse reactions, including inflammatory reactions in soft tissue, heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence. The original Food and Drug Administration Summary of anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejaculation (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. It had been debated whether this finding was related to rhBMP-2 use.. To compare the incidence of RE after ALIF in patients with and without rhBMP-2 use.. Retrospective analysis of prospectively gathered outcomes data on consecutive subjects having ALIF with and without rhBMP-2 use.. Male patients with lumbar spondylosis or spondylolisthesis having ALIF of the lowest one or two lumbar levels with and without rhBMP-2.. Report of RE as a new finding after ALIF.. From the comprehensive outcome database at a high-volume university practice, male subjects having ALIF for one- (L5/S1) or two-level (L4/L5, L5/S1) lumbar fusion were identified. Retrograde ejaculation events were recorded and comparative incidence compared.. The two groups were comparable for age and additional procedures performed. There were 69 L5/S1 ALIFs performed with rhBMP-2 and 174 ALIFs performed without rhBMP-2 during the study period. Of those, 24 and 64 were two-level ALIFs performed with and without rhBMP-2, respectively. There were five RE events (7.2%) reported in the rhBMP-2 group and 1 (0.6%) in the control group. Comparing single-level L5/S1 ALIF, there was a 6.7% and 0% rate of RE in the rhBMP-2 versus control groups, respectively. At 1 year after surgery, three of six affected subjects reported resolution of the RE.. This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2. This may be an important consideration in subjects concerned with sterility after surgery.

Topics: Adult; Aged; Bone Morphogenetic Protein 2; Cohort Studies; Ejaculation; Humans; Lumbar Vertebrae; Male; Middle Aged; Postoperative Complications; Recombinant Proteins; Retrospective Studies; Sexual Dysfunction, Physiological; Spinal Fusion; Spondylosis; Transforming Growth Factor beta; Young Adult

Topics: Bone Morphogenetic Protein 2; Humans; Male; Postoperative Complications; Recombinant Proteins; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta

Topics: Bone Morphogenetic Protein 2; Humans; Male; Postoperative Complications; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta

Topics: Bone Morphogenetic Protein 2; Humans; Male; Postoperative Complications; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta

Topics: Bone Morphogenetic Protein 2; Clinical Trials as Topic; Conflict of Interest; Humans; Male; Postoperative Complications; Research Design; Sexual Dysfunction, Physiological; Spinal Fusion; Transforming Growth Factor beta