Office intrauterine morcellation for retained products of conception.

OBJECTIVE: Proposing hysteroscopic morcellation (HM) as a surgical-therapeutic approach in the treatment of retained products of conception (RPOC) to prevent intrauterine adhesions (IUAs). DESIGN: Prospective analysis. SETTING: A teaching and university hospital. PATIENTS: Women with RPOC. INTERVENTIONS: Office -HM with 'Truclear 5 C'. MATERIAL AND METHODS: Twenty-two consecutive patients presenting with trophoblastic residue retention after miscarriage and interruption of pregnancy or placenta remnants after cesarean section or delivery were enrolled. These women underwent office-HM with 'Truclear 5 C'. Primary outcomes were median time and rate of hospitalization. The quality of the specimen was also analyzed. A hysteroscopic second look for IUAs was performed. RESULTS: Mean procedure time was six minutes (SD ± 5). Tissue samples had a mean collection size 2.5 cm3+0.9. 38% of the samples had spotting or abnormal vaginal discharge. Dilatation of the cervical canal was not performed in any case. Second-look hysteroscopy did not show any de novo IUAs in any of the enrolled patients. CONCLUSIONS: In the hysteroscopic treatment of RPOC, HM is a valid choice in an office setting without the use of cervical dilatation. Removal of RPOC was uneventful in all cases, simple and carried out faster without any adverse outcomes.

Clinical analysis of the MyoSure hysteroscopic tissue removal system of endometrial polyps in women with an intact hymen.

BACKGROUND: To investigate the clinical efficacy of the MyoSure hysteroscopic tissue removal system in the treatment of endometrial and cervical polyps in women with an intact hymen. METHODS: Retrospective analysis was performed on the clinical data of 32 patients treated with the MyoSure hysteroscopic tissue removal system for endometrial and cervical polyps. RESULTS: All the patients successfully completed the procedure. No intraoperative complications, such as cervical trauma, uterine perforation or TURP syndrome, were reported. The surgical time ranged from 5 to 35 min, with an average time of 19.3 min, and the intraoperative blood loss ranged from 2 to 50 ml with an average blood loss of 10.8 ml. After surgery, all patients were shown to have intact hymens. No residual polyp tissues were observed under the microscope, and abnormal uterine bleeding was relieved. CONCLUSIONS: The MyoSure hysteroscopic tissue removal system can be a safe and effective treatment for endometrial and cervical polyps in women with an intact hymen.

Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.

STUDY OBJECTIVE: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DESIGN: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SETTING N/A PATIENTS: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. INTERVENTIONS: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. MEASUREMENTS AND MAIN RESULTS: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. CONCLUSIONS: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.

A prospective study of the use of the Myosure resectoscope to manage endometrial polyps in an outpatient setting.

BACKGROUND: The Myosure resectoscope has been in use since 2009. Our unit is the first in Australia to describe the use of the Myosure device in the outpatient setting to resect endometrial polyps. AIM: To compare patient satisfaction and pain scores of pre- and postmenopausal women undergoing outpatient removal of endometrial polyps using the Myosure device. MATERIAL AND METHODS: Public hospital based prospective study. Patients (n=42) who opted to have resection of endometrial polyps under local anaethesia were recruited. Procedures were performed using a 6.25-mm hysteroscope with a MyoSure Lite device. Patient experiences were collected using a questionnaire immediately postprocedure. Pain level was assessed using 100-mm visual analogue score (VAS). Resection times and untoward events were recorded. RESULTS: Mean endometrial polyp size was 13 mm and the mean resection time was 39.4s. Complete resection was achieved in 95.2% of cases. The median VAS was 2.7 (range 0.7-7.5). The pain scores did not differ significantly between nulliparous or parous women who only had a caesarean section delivery and those who have delivered vaginally. However, VAS was statistically less in postmenopausal women in comparison with premenopausal women (2.5 vs 3.2, respectively; (P = 0.047)). Overall, women were very satisfied; 97.6% would recommend the procedure to a friend and 95.2% happy to consider a repeat procedure in the future if required. The complication rate was 4.8%, and all were minor in nature. CONCLUSION: Operative hysteroscopic procedures can be performed successfully in the outpatient setting using the Myosure Lite device with a high level of patient satisfaction.

Pain experience with outpatient hysteroscopy: A prospective cohort study.

BACKGROUND: Abnormal uterine bleeding (AUB) affects women of all ages and is one of the most common reasons for referral to a gynaecological clinic. Operative hysteroscopic procedures allow for a see-and-treat approach to AUB, and these techniques have been shown to be feasible and acceptable in the outpatient setting. OBJECTIVE: To assess if there is an increase in pain scores for women who are undergoing an operative hysteroscopic procedure with Myosure LITE® (Hologic; mechanical hysteroscopic tissue removal system) compared to outpatient diagnostic hysteroscopy alone. STUDY DESIGN: A prospective cohort study was performed. All participants attending the outpatient hysteroscopy clinic at Mercy Hospital for Women completed a pre-and post-procedure questionnaire. This included a visual analogue scale (VAS) for any pre-existing pain, anticipated pain, and actual pain experienced during procedure. Factors influencing overall satisfaction and willingness to attend again were also assessed. Data was entered into RedCap® for analysis. A difference in VAS of 10 mm or more was considered clinically significant. An alpha of p < 0.05 was assigned for statistical significance. RESULTS: Between February 2020 and November 2022, 208 women underwent outpatient diagnostic hysteroscopy followed by an operative hysteroscopy with MyoSure®. To allow for standardisation of analgesia, only participants who had a cervical block before their Myosure® procedure were included for analysis (n = 111). There was statistical evidence (t(111) = 2.36, p = 0.02) of a lower mean VAS pain score for operative Myosure (36.5 mm, 95 % CI: 31.1-41.8 mm) compared to outpatient diagnostic hysteroscopy (44.1 mm, 95 % CI: 39.0-49.2 mm). The mean difference in VAS pain score was estimated as 7.7 mm (95 % CI: 1.2-14.1 mm) lower for Myosure compared to hysteroscopy. Given the threshold for clinical significance was considered as 10 mm difference in VAS, the variance in pain scores is under the likely clinically significant range. There was no significant difference in pain scores for diagnostic hysteroscopy with or without paracervical block (mean difference = 1.42; 95 % CI: -6.35 to 9.20). There was no association between pre-existing pain, and actual pain for hysteroscopy, or Myosure (p = 0.997 and p = 0.065 respectively). The anticipated pain score was weakly associated with actual pain during the operative Myosure procedure (p = 0.02), and with outpatient diagnostic hysteroscopy (p = 0.019). CONCLUSION: Outpatient hysteroscopy procedures are generally well tolerated. The pain experience with operative Myosure was less than that reported during the diagnostic hysteroscopy by the same patient although this is unlikely of clinical significance. Importantly, Myosure was not more painful than the initial diagnostic procedure, and most patients were satisfied with the outcome and would choose to have the procedure again in an outpatient setting. This is in keeping with other studies which have shown a high degree of patient tolerance and satisfaction with this approach.

Comparative analysis of the clinical efficacy and reproductive outcomes of the hysteroscopic tissue removal system (MyoSure) and hysteroscopic electroresection in the treatment of benign intrauterine lesions.

OBJECTIVE: To compare and analyze the clinical efficacy and reproductive outcomes of the hysteroscopic tissue removal system (MyoSure) and hysteroscopic electroresection in the treatment of benign intrauterine lesions in women of reproductive age. METHODS: This is a retrospective study of patients with benign intrauterine lesions treated with MyoSure or hysteroscopic electroresection. The primary outcomes were operative time and resection completeness, and reproductive outcomes were followed up and compared. Secondary outcomes included perioperative adverse events and postoperative adhesions seen during second-look hysteroscopy. Data analysis was performed using χ2 and Fisher tests for qualitative variables and Student t-test for quantitative variables. RESULTS: The operative times of patients with type 0 or I myoma, endometrial polyps, or retained products of conception in the MyoSure group were shorter than those in the electroresection group but were not significantly different for patients with type II myomas. The complete resection rate was lower in the MyoSure group than in the electroresection group. The degree of decrease in the American Fertility Society score of intrauterine adhesion in the MyoSure group was significantly higher (2.90 ± 1.29 points vs 1.31 ± 0.89 points, P = 0.025). The time to pregnancy and the pregnancy rate were higher in the MyoSure group (13.14 ± 7.85 months vs 16.26 ± 8.22 months, P = 0.040; 65.12% vs 54.55%, P = 0.045), but there was no significant difference in the term live birth rate, premature birth rate, or abortion rate between the two groups. CONCLUSION: MyoSure has advantages of a shortened operative time and improvement in reproductive outcomes such as pregnancy rate. However, for type II myomas, MyoSure has limitations, and a comprehensive evaluation before the procedure is required.

Evaluation of the Safety and Efficacy of Resection of Endometrial Polyps and Submucosal Fibroids in an Outpatient Setting in a Large District General Hospital in the UK.

Background: Conventionally, endometrial pathologies of varying complexity have been surgically treated as inpatients under a general or regional anesthetic. Aim: In this paper, we evaluate the safety and efficacy of hysteroscopic morcellation of endometrial pathology in the form of endometrial polyps (EPs) and submucosal fibroids in an outpatient setting for both simple and complex lesions using the Myosure™ device. Methods: Two hundred and forty-nine hysteroscopic resections were performed in an outpatient setting at the < BLINDED FOR REVIEW > from May 2014 to March 2021. The median age of the patients was 54 years. More than half of the patients presented with postmenopausal bleeding; 64% were diagnosed with EPs and 24% with submucous fibroids (SMFs). The size, topography, extension, penetration, and wall classification system scoring system were used to grade them as simple (≤4) or complex (≥5) pathologies. Results: 90% of pathologies were simple (≤4), of which complete resection was carried out in 95% of patients; 10% of the pathologies were complex (≥5), of which 63% had complete resection. Two patients with complex pathologies returned for completion surgery as a two-step procedure. No procedure was abandoned due to the patient intolerance. The median intraprocedure pain score visual analog scale was 5/10 and immediate postprocedure pain score was 1/10. Notably, there was no intra- or post-procedure complications. Conclusion: Outpatient resection of endometrial pathology, both simple and complex, can be safely and effectively performed using hysteroscopic morcellator (Myosure™) and is accepted and well tolerated by patients.

Mini-resectoscope vs morcellator for in-office hysteroscopic myomectomy: Evaluation of results and patient satisfaction.

INTRODUCTION: The development of hysteroscopic techniques has led to an advance in submucous myoma treatment, offering a safe and effective minimally invasive alternative. Our objective was to compare the results of hysteroscopic myomectomy when using whether the mini-resectoscope or the MyoSure morcellator, as well as patient satisfaction after the procedure. MATERIAL AND METHODS: A prospective, cross-sectional, observational study including 80 patients distributed into two groups: Mini-Resectoscope group (MRG) or MyoSure group (MSG), depending on the instrument used for the in-office hysteroscopic myomectomy. Resection time, pain during entry, pain during resection, number of resections required, complete resection, and total satisfaction were recorded. RESULTS: MSG had statistically significant shorter time of entrance. There were no other statistically significant differences between groups. CONCLUSIONS: In-office hysteroscopic myomectomy is associated with high levels of patient satisfaction, without differences between the mini-resectoscope or the MyoSure, allowing high rates of complete resection using both instruments. Thus, it is a feasible technique which could be performed with both instruments, depending on the operator's expertise.

Office hysteroscopic morcellation service: Evaluation of women experience and factors affecting satisfaction.

OBJECTIVES: To evaluate the hysteroscopic morcellation service in office-setting in everyday practice outside the context of clinical trials. The primary objectives were to assess level of acceptability and factors affecting women satisfaction. The secondary objectives included assessment of complete resection rate, complications rate, pain score during the procedure and on discharge, and the correlation between the lesion size as subjectively estimated by the hysteroscopists versus the volume of morcellated tissues as semi-quantitively measured by the laboratory. METHOD: The clinical data was compiled for 287 consecutive women undergoing hysteroscopic morcellation in office-setting from 1 January 2017 to 31 March 2021 in a teaching hospital in the UK. A questionnaire, formulated on the Visual Analogue Scale (VAS), was completed immediately after the procedure by the last 110 women undergoing the procedure. RESULTS: The mean age of the cohort (n = 278) was 54.5 years (SD ± 12.5). Only 7 (2.4%) women required two-stage procedure because of size (fibroid ≥ 4 cm), vascularity or multiplicity of lesions. No complications were encountered. The majority of women completing the questionnaire (n = 110) found office procedure acceptable (105, 95.5%, VAS ≥ 7), were willing to have it again if indicated (102, 92.7%, VAS ≥ 7), would recommend it to family and friends (105, 95.5%, VAS ≥ 7) and confirmed receiving adequate preoperative information by doctors and nurses (107, 97.3%, VAS ≥ 7). The level of preoperative explanation and information-giving showed significant (p < 0.01) positive correlation with the level of acceptability and recommendation to others and significant (p = .007) negative correlation with the pain experienced on discharge. The median (IQR) estimated size at hysteroscopy was 2 cm (1-6 cm) for polyps and 2.5 cm (1-4 cm) for fibroid. The median (IQR) volume of the morcellated specimens as estimated by laboratory was 2000 mm3 (1100-3800 mm3). The estimated size at hysteroscopy was positively correlated with the specimen's volume (Spearman's rho (r) = 0.31, 95% = CI, 0.14-0.45, p < 0.01). CONCLUSION: Office hysteroscopic morcellation is associated with high satisfaction rate and low pain score on discharge. Good preoperative explanation and information-giving was the crucial factor that increased women satisfaction. Subjective estimation of lesion size by hysteroscopists may be an accurate and simple method of measurement.

Successful Use of Myosure in the Management of Cesarean Scar Ectopic Pregnancy.

Cesarean scar pregnancy (CSP) is a very serious complication of a prior cesarean delivery. The major risks associated with CSP are uncontrolled hemorrhage and uterine rupture, potentially leading to future infertility. Management of CSP remains a major obstetric challenge without a well-defined therapeutic procedure. Dilation & curettage is a commonly used procedure for the treatment of CSP. However, it can be ineffective and often leads to definite infertility. Therefore, we present a case of the successful use of an alternative procedure, Myosure® hysteroscopy, in the treatment of CSP. We herein report the case of a 32-year-old G5P3013 woman who presented with vaginal bleeding and past history of three cesarean sections. She was found to have a CSP with fetal pole and cardiac activity at 6 weeks 2 days. The patient was initially treated with a systemic methotrexate injection, but there was persistence of cardiac activity. A second course of methotrexate was administered into the gestational sac, which systemically led to successful fetal cardiac arrest and downtrend of beta-human chorionic gonadotropin (HCG) level. A dilation & curettage procedure was not successful in removing products of conception. A Myosure hysteroscopy procedure, however, was successful in removing products of conception. The patient was discharged after a negative ultrasound and beta-HCG level. In our review of the literature, we found that there is no general consensus on the management of cesarean scar ectopic pregnancies. To date, there is no literature cited about the use of Myosure for cesarean scar ectopic pregnancies. However, our case suggests that Myosure can be effective for CSP and this warrants a larger-scale controlled study to better evaluate this as a treatment for this condition.

Hysteroscopic tissue removal systems for the treatment of intrauterine pathology: a systematic review and meta-analysis.

BACKGROUND: The use of mechanical tissue removal systems is more frequently implemented as the first line approach for the treatment of intrauterine pathology. Scientific evidence is provided that their use is easier and faster than the conventional resectoscope. It is necessary to objectively evaluate the results on tissue removal systems for the treatment of endometrial pathology as the reports in the literature are still conflicting. OBJECTIVE: To review and compare mechanical hysteroscopic tissue removal systems (Truclear®, Myosure® or IBS®) versus conventional bipolar and monopolar resectoscopy for the treatment of polyp and myoma removal. Operation time, completeness of tissue removal, complication rate, fluid deficit, tolerability and learning curve were evaluated. METHODS: Electronic databases PubMed; Medline and Web of Science were searched for papers published from 1st January 2010 to 1st May 2019 using terms: ("hysteroscopic" or "hysteroscopy" or "hysteroscopic surgery") and ("myoma" or "polyps"). Studies were included if they were retrospective, observational and prospective randomized clinical controlled trials if they investigated the techniques between the tissue removal systems (Truclear®, Myosure® or IBS®) and conventional resectoscopy for the treatment of intrauterine pathology. Data were extracted from the included studies by two independent reviewers. Meta-analysis was performed by Rev Man 5 software (Cochrane Collaboration, London, UK). Results: Overall, 498 patients were analysed from five studies in which there was no difference in age and size of pathology treated either by the hysteroscopic tissue removal systems and the conventional resectoscope. Hysteroscopic tissue removal systems showed a significantly higher success rate of complete endometrial pathology removal (P=0.002) and a significantly shorter operation time for polyp removal (P<0.0001) compared to conventional resectoscopy. No significant differences, in terms of complications rate, were found (P=0.09). The fluid deficit was significantly higher in the tissue removal system group, compared to conventional resectoscopy (P=0.02). CONCLUSION: Hysteroscopic tissue removal systems showed a major advantage in successful removal of the pathology and total operation time. It is likely that the tissue removal systems are more accessible and have a lower complication profile including perforation, via falsa and bleeding due to its specific action mechanism and shorter operation time but higher-quality trials will be required to confirm this hypothesis.

Hysteroscopic tissue removal system (MyoSure) for the resection of polyps, sub-mucosal leiomyomas and retained products of conception in an out-patient setting: A single UK institution experience.

PURPOSE: The present study aimed to elucidate the hysteroscopic tissue removal system (MyoSure) efficacy and safety amongst uterine cavity pathologies (UCPs), and to determine its feasibility in an outpatient setting. We also sought to identify possible factors that could adversely affect complete lesion excision. METHODS: 124 women underwent MyoSure procedure and 135 UCPs were excised, between January 2017 and January 2018. The MyoSure efficacy was evaluated, and potential factors correlated with increased incomplete excision rate were assessed, using both univariate and multivariate analysis. RESULTS: The overall MyoSure excision rate was 94.8%. 107/109 polyps and 14/19 leiomyomas were completely resected with a success rate of 98.1% and 73.7% respectively. The complete excision rate amongst retained products of conception (RPOC) cases was 100%. A significant correlation between leiomyomas and incomplete excision was found when compared to polyps and RPOC (p < 0.001). In this cohort, type II leiomyomas (OR = 1.8, p = 0.01) and maximal diameter > 4 cm (OR = 1.6, p = 0.02) were independently correlated with incomplete leiomyomas excision. Nine out of 124 women (7.3%) experienced severe pain during the procedure, while 17% and 73% reported moderate and mild pain respectively. Furthermore, 99% of women (123/124) would undergo the procedure again in the future or recommend it to a friend, for a similar pathology removal. CONCLUSIONS: MyoSure is an efficient, safe and feasible operative hysteroscopic procedure in an office-outpatient setting. It is associated with high patient acceptability and, it is highly recommended by the vast majority of the women. Large, and type II leiomyomas are seemingly procedure limitations.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas.

PURPOSE: To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure(®) device. PATIENTS AND METHODS: This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm. The main outcomes were a composite measure of procedure-related pain and pain during the postoperative recovery period, assessed by the Wong-Baker Faces Rating Scale (0= no pain to 10= maximum pain). The lesion characteristics, procedure time, and adverse events were summarized. RESULTS: A total of 17 polyps and eight myomas were removed in the para/intracervical block group, with diameters of 1.3±0.5 cm and 1.8±0.8 cm, respectively. In the intracervical block group, 25 polyps with a mean diameter of 1.2±0.7 cm and 7 myomas with a mean diameter of 1.9±0.9 cm were removed. The mean tissue resection time was 1.2±2.0 minutes and 1.2±1.4 minutes for the para/intracervical and intracervical block groups, respectively. The mean composite procedure-related pain score was low for both cervical block protocols, 1.3±1.4 in the para/intracervical block group vs 2.1±1.5 in the intracervical block group. During the postoperative recovery period, the mean pain scores were 0.3±0.7 vs 1.2±1.7 for the para/intracervical and intracervical block groups, respectively. There were no serious adverse events. CONCLUSION: The MyoSure procedure for removal of polyps and myomas was well tolerated, with low pain scores reported for both the para/intracervical and intracervical block protocols.

Efficacy comparison of different hysteroscopic surgical procedures in treatment of endometrial polyps / 实用医学杂志

Objective To compare the efficacy of different hysteroscopic surgical procedures in the treatment of endometrial polyps. Methods Ninety-two patients with endometrial polyps from January 2016 to December 2017 were selected. Among them, 37 patients with fertility requirements underwent polypectomy with MyoSure as group A; 25 patients without fertility requirements underwent polypectomy with resectoscopic hysteroscopy as group B, and 30 patients underwent polypectomy with hysterosopy and curettage as group C. The duration of the procedure, blood loss and hospital stays, effective rate, recurrence rate and postoperative pregnancy rate of the3 groups were compared. Results There was no significant difference in intraoperative blood loss and hospital stays among the 3 groups (P> 0.05). The duration of the procedure of group A and B was longer than that of group C, and the difference was statistically significant (P < 0.05). The effective rate of treatment was high in all 3 groups, and inter-group comparison indicated no statistically significant difference, but the recurrence rate of group C was significantly higher than that of group A and B. For those with fertility requirements, the pregnancy rate in group A was slightly higher than that in group C within one year after surgery, but the difference was not statistically significant. Conclusion Hysteroscopic procedures of endometrial polypectomy has the advantages of accuracy, safety, effectiveness and rapid recovery. The treatment with MyoSure and resectoscopic hysteroscopy can reduce the recurrence rate of patients effectively. For women with fertility requirements, the treatment with MyoSure can protect the endometrium and improve the postoperative pregnancy rate.