Treatment strategies in patients with gynecological sarcoma: Results of the prospective intergroup real-world registry for gynecological sarcoma in Germany (REGSA-NOGGO RU1).

OBJECTIVE: Gynecological sarcomas account for 3% of all gynecological malignancies and are associated with a poor prognosis. Due to the rarity and heterogeneity of gynecological sarcomas there is still no consensus on optimal therapeutic strategies. This study's objective was to describe the treatment strategies used in patients with gynecological sarcomas in the primary course of disease. METHODS: The German prospective registry for gynecological sarcoma (REGSA) is the largest registry for gynecological sarcomas in Germany, Austria and Switzerland. Primary inclusion criteria for REGSA are histological diagnosis of sarcoma of the female genital tract, sarcoma of the breast or uterine smooth muscle tumors of uncertain malignant potential (STUMP). We evaluated data of the REGSA registry on therapeutic strategies used for primary treatment from August 2015 to February 2021. RESULTS: A total of 723 patients from 120 centers were included. Data on therapeutic strategies for primary treatment were available in 605 cases. Overall, 580 (95.9%) patients underwent primary surgery, 472 (81.4%) of whom underwent only hysterectomy. Morcellation was reported in 11.4% (n=54) of all hysterectomies. A total of 42.8% (n=202) had no further surgical interventions, whereas an additional salpingo-ophorectomy was performed in 54% (n=255) of patients. An additional lymphadenectomy was performed in 12.7% (n=60), an omentectomy in 9.5% (n=45) and intestinal resection in 6.1% (n=29) of all patients. Among 448 patients with available information, 21.4% (n=96) received chemo- or targeted therapies, more commonly as single-agent treatment than as drug combinations. Information about anti-hormonal treatment was available for 423 patients, among which 42 (9.9%) received anti-hormonal treatment, 23 (54.8%) of whom with low-grade endometrial stroma sarcomas. For radiotherapy, data of 437 patients were available, among which 29 (6.6%) patients underwent radiotherapy. CONCLUSION: Our study showed that treatment of patients with gynecologic sarcomas is heterogeneous. Further trials are needed along with more information on treatment modalities, therapy response and patient-reported outcomes to implement new treatment strategies.

German gynecologic societies investigating their Nazi past.

PURPOSE: Research into the activities of German medical specialist associations during the Nazi period is still in its initial stages even today. In the field of gynecology and obstetrics as well, most representatives of the discipline continued to take an attitude based on "concealment and forgetting", even after the turn of the millennium. In order to break with this approach, the Bavarian Society for Obstetrics and Gynecology (Bayerische Gesellschaft für Geburtshilfe und Frauenheilkunde, BGGF) commissioned an interdisciplinary research group to focus on clarifying its Nazi past for the purposes of a history of the institution on the occasion of its centenary. METHODS: The research was based on the Society's archive. When the files were found to show conspicuous gaps for the Nazi period, the investigation was extended into the role of BGGF representatives and members who were active at the time. In some cases, it was possible to draw on existing studies and to supplement the available information from additional archival sources. RESULTS: It was found that the BGGF started at a very early stage to marginalize and ignore its "non-Aryan" members. No official decision to exclude such members was apparently taken, however. Many representatives and honorary members of the society were involved in promoting and carrying out eugenic sterilizations, simultaneously conducting abortions on some victims, and they at least shared responsibility for forced abortions among Ostarbeiterinnen ("Eastern workers", forced laborers from Eastern Europe). Accompanying unethical research that was mainly intended to garner academic prestige for the physicians involved was never discussed at the Society's conferences. Representatives of the Society who were substantially incriminated were able to continue their careers almost without interruption after 1945.

Improvement of survival in sex cord stromal tumors - an observational study with more than 25 years follow-up.

OBJECTIVE: To highlight aspects of malignant ovarian sex cord stromal tumors, effects of treatment, and developments over the past 28 years. DESIGN: Population-based cohort study. SETTING: Gynecological departments within the catchment-area of the Munich Cancer Registry and associated with the project group 'Malignant Ovarian Tumors' of the Munich Cancer Center. SAMPLE: One hundred and forty-five women with an invasive single sex cord stromal tumor diagnosed between 1978 and 2005. METHODS: Overall survival was estimated with the Kaplan-Meier method, relative survival was computed by the ratio of observed to expected survival rate. The impact of age, International Federation of Gynecology and Obstetrics (FIGO)-stage, residual tumor, and chemotherapy was examined by multivariate analysis (Cox regression model). MAIN OUTCOME MEASURES: Overall and relative survival and multivariate adjusted overall survival. RESULTS: Survival data showed a five-/10-year overall survival of 55.8%/42.8% (relative survival 58.6%/49.2%) for women diagnosed before 1988 and 89.1%/78.3% (relative survival 92.7%/85.2%) for women diagnosed after 1988. After adjustment for age and FIGO-stage, the following hazard ratios and 95% confidence intervals (95% CI) for treatment methods resulted: 3.3 (95% CI 1.5-7.0) for women with compared to women without residual tumor and 2.2 (95% CI 1.2-4.2) for women with chemotherapy compared to women where no chemotherapy was given. CONCLUSIONS: Improvements in survival may be attributed to a stage-shift toward more favorable stages at diagnosis and to advances in treatment such as improved surgery without residual tumor. There is no evidence for any benefit of adjuvant chemotherapy. Surgery remains the cornerstone of treatment, yet the benefit of postoperative therapy is still under debate.

Influence of spontaneous and instrumental vaginal delivery on objective measures of pelvic organ support: assessment with the pelvic organ prolapse quantification (POPQ) technique and functional cine magnetic resonance imaging.

OBJECTIVE: To determine the influence of spontaneous and instrumented vaginal delivery on objective measures of pelvic organ support. STUDY DESIGN: Prospective study at a university hospital with two study groups: vaginal spontaneous delivery (n = 26) and vacuum extraction (n = 49). Control group consisted of healthy nulliparous volunteers (n = 20). Participants underwent pelvic organ support evaluation by use of the pelvic organ prolapse quantification (POPQ) examination and postpartum functional cine magnetic resonance imaging (MRI). RESULTS: Significant differences for individual POPQ component measurements were noted for points Aa and Ba, TVL, and GH (spontaneous delivery versus control) and in addition for Ap, Bp, and D (vacuum extraction versus control). Significant differences for MRI measurements were observed for the position of bladder base, bladder neck, posterior fornix of the vagina, anorectal junction, hiatus perimeter and depth of rectocele. CONCLUSIONS: Considerable changes in pelvic organ support after vaginal delivery can be demonstrated by a reproducible and reliable clinical classification system (POPQ) and by functional cine magnetic resonance imaging.

EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients.

PURPOSE: The aim of the study was to determine the short- and long-term efficacy of an intensive and EMG-biofeedback-assisted pelvic floor muscle training (PFMT) program as a therapy of female stress or mixed urinary incontinence. MATERIALS AND METHODS: All women with stress or mixed urinary incontinence treated in the pelvic floor reeducation program at our clinic between September 1996 and March 2003 were included. EMG-biofeedback assisted PFMT was performed by specially trained therapists (one registered nurse and one midwife). Electric stimulation preceded PFMT if the pelvic floor muscle contractions were considered too weak for active training (Oxford < 2). Examinations included among others: conventional urodynamic studies prior to therapy, a stress provocation test (cough test), and determination of maximal pelvic floor muscle strength (Oxford-grading and electric EMG-potential). A retrospective chart review was performed. A questionnaire was administered for long-term follow-up. RESULTS: Four hundred and thirty four women attended our PFR-program in this 7-year period. All 390 women with stress (80%) or mixed (20%) urinary incontinence were evaluated. Mean age: 52 years. Mean duration of incontinence: 6.7 years. Two hundred and sixty three women completed the training (group 1, average number of training sessions: 8.7), 127 patients ended therapy prematurely (group 2, average number of training sessions: 4.1). Short-term results at the end of the PFR-program are available for group 1. There was a statistically significant improvement of the stress provocation test (cough test). The data before the therapy was 141x SUI degrees III (60%); 50x SUI degrees II (21%), 24x SUI degrees I (10%), 20x SUI degrees 0 (9%) as opposed to after the therapy 9x SUI degrees III (5%), 34x SUI degrees II (19%), 48x SUI degrees I (26%), 91x SUI degrees 0 (50%). There was a significant increase in the Oxford-score by 1.2 points (2.9-4.1; P<0.001). Self-reported improvement of incontinence symptoms was 95%. The electric EMG-potentials almost doubled (11.3-20.5 muV; P<0.001). Long-term results (questionnaire) for all patients: the average follow-up time was 2.8 years (range: 3 months to 7 years). Three hundred and twelve (80%) of the questionnaires returned. Seventy-one percent of them self-reported a persisting improvement of their incontinence symptoms. Thirteen percent of all women underwent incontinence surgery following the completion of conservative therapy (9.2% group 1, 25% group 1; P<0.001). CONCLUSIONS: An intensive and EMG-biofeedback assisted PFMT is very effective. Often, avoidance of surgery is possible.

Episiotomy and perineal tears presumed to be imminent: the influence on the urethral pressure profile, analmanometric and other pelvic floor findings--follow-up study of a randomized controlled trial.

BACKGROUND: The influence of the restrictive use of episiotomy at perineal tears judged to be imminent on the urethral pressure profile, analmanometric, and other pelvic floor findings is unknown. METHODS: Follow-up study of a randomized controlled trial with two perineal management policies includes the use of episiotomy: (a) only for fetal indications and (b) in addition at a tear presumed to be imminent. Participants were 146 primiparous women with an uncomplicated singleton pregnancy >34 weeks of gestation. For the intention-to-treat analysis, 68 women after vaginal delivery were included who delivered a live full-term baby between January 1999 and September 2000. OUTCOME MEASURES: Maximum urethral closure pressure (MUCP, cmH2O), functional urethral length (mm), maximum anal pressure (MAP, mmHg), functional anal sphincter length (ASL, mmHg) at rest and during contraction, and pelvic floor muscle strength (5-grade Oxford score) are the outcome measures. The rate of dyspareunia, urinary incontinence, and anorectal incontinence was documented. RESULTS: At a mean follow up of 7.3 months, there were no statistically significant differences between the two groups (a versus b): mean MUCP at rest (98 versus 101 cmH2O), during contraction (95 versus 103 cmH2O), mean MAP at rest (113 versus 121 mmHg), during contraction (143 versus 166 mmHg), mean ASL at rest (50 versus 50 mmHg), during contraction (42 versus 45 mmHg), mean pelvic floor muscle strength (2.2 versus 2.6), no pain during sexual intercourse (79 versus 67%), prevalence of urinary incontinence (48 versus 27%), and anorectal incontinence (19 versus 24%). CONCLUSIONS: Episiotomy at a perineal tear presumed to be imminent does not have any advantage with regard to pelvic floor function and should be avoided.

Episiotomy and perineal tears presumed to be imminent: randomized controlled trial.

BACKGROUND: The indication of the restricted use of episiotomy at tears presumed to be imminent is not clear. METHODS: Randomized controlled trial with two perineal management policies. Use of episiotomy: (a). only for fetal indications and (b). in addition at a tear presumed to be imminent. PARTICIPANTS: 146 primiparous women with an uncomplicated singleton pregnancy at >34 weeks of gestation. For the intention-to-treat analysis those 109 women were included who vaginally delivered a live full-term baby between January 1999 and September 2000: 49 women in group a, 60 in group b. OUTCOME MEASURES: Reduction of episiotomies, increase of intact perinea or only minor perineal trauma (intact perineum and first-degree tears), third-degree tears, anterior perineal trauma, perineal pain in the postpartum period, pH of the umbilical artery, Apgar scores, maternal blood loss. RESULTS: Episiotomy rates were 41% in group a and 77% in group b (p < 0.001). Women in the restrictive policy group had a greater chance of an intact perineum (29% vs. 10%; p = 0.023) or only minor perineal trauma (39% vs. 13%; p = 0.003) and had significant lower pain scores postpartum at different activities. There were no statistically significant differences with regard to third-degree tears, anterior trauma, pre- and postpartum hemoglobin concentrations, Apgar scores and pH of the umbilical artery. CONCLUSIONS: Avoiding episiotomy at tears presumed to be imminent increases the rate of intact perinea and the rate of only minor perineal trauma, reduces postpartum perineal pain and does not have any adverse effects on maternal or fetal morbidity.

Assessment of pelvic organ descent by use of functional cine-MRI: which reference line should be used?

BACKGROUND AND AIMS: So far there is no agreement between clinical and radiological measurements and reference points for the quantification of pelvic organ descent in women. The aim of this study was to find out which of three reference lines on functional cine-magnetic resonance imaging (MRI) correlates best with the respective clinical diagnoses. METHODS: We retrospectively evaluated the functional cine-MRI studies of 41 asymptomatic volunteers. Our golden standard was the results of the clinical examination using the International Continence Society (ICS)-score. On MRI, we measured the distance of the bladder-neck, distal edge of cervix/posterior fornix, and the most ventrocaudal point of the ventral rectal wall, respectively, to the pubococcygeal line (PCL), the horizontal tangent of the inferior rim of the pubic bone, and the line drawn through the long axis of the pubic bone. The results were correlated with the respective clinical findings using descriptive analysis alone. RESULTS: The volunteers either showed a Stage 0 (16 cases), Stage I (12 cases), or a Stage II (13 cases) organ descent on clinical examination with 10 women (24.4%) having a pathological ICS-score in the anterior, 15 women (36.1%) in the superior, and 4 women (9.8%) in the posterior compartment. On functional MRI the best correlation with the clinical results was achieved using the PCL for the anterior compartment (22.0%), the PCL with an offset of +3 cm for the superior (36.6%), and the hymenal line (HL) for the posterior compartment (9.8%). CONCLUSIONS: Organ descent on functional cine-MRI cannot be described using only one reference line. In order to optimize clinical exploitation of functional MRI of the pelvic floor a consensus regarding imaging protocols and evaluation criteria should be aimed for.