Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.

BACKGROUND: Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients. However, data from large, randomized trials comparing outcomes of radical and simple hysterectomy are lacking. METHODS: We conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). The primary outcome was cancer recurrence in the pelvic area (pelvic recurrence) at 3 years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years was 4 percentage points. RESULTS: Among 700 patients who underwent randomization (350 in each group), the majority had tumors that were stage IB1 according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%). With a median follow-up time of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group (an absolute difference of 0.35 percentage points; 90% confidence interval, -1.62 to 2.32). Results were similar in a per-protocol analysis. The incidence of urinary incontinence was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (2.4% vs. 5.5%; P = 0.048) and beyond 4 weeks (4.7% vs. 11.0%; P = 0.003). The incidence of urinary retention in the simple hysterectomy group was also lower than that in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001). CONCLUSIONS: In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.).

Aesthetic Outcome and Psychosexual Distress After Treatment for Vulvar High-Grade Squamous Intraepithelial Lesions.

OBJECTIVES: This study compared aesthetic outcome, psychosexual distress, and treatment satisfaction between women receiving surgical treatment or medical treatment with imiquimod for vulvar high-grade squamous intraepithelial lesion. MATERIALS AND METHODS: This is an extended analysis of the multicenter, randomized noninferiority trial "topical imiquimod versus surgery for vulvar intraepithelial neoplasia." Patients were randomized to primary topical treatment or surgery and stratified by unifocal or multifocal disease. Digital photos of vulvar appearance were subsequently assessed for aesthetic outcome by 3 investigators blinded to group allocation. Psychosexual distress and treatment satisfaction were assessed with the Cervical Dysplasia Distress Questionnaire, the Sexual Activity Questionnaire, and the Client Satisfaction Questionnaire at baseline and follow-up. RESULTS: One hundred ten patients aged between 19 and 82 years were enrolled. Per-protocol analysis showed complete clinical response in 80% (37/46) using imiquimod, compared with 79% (41/52) after one surgical intervention. Photodocumentation at baseline and 6-month follow-up was available for 84 of these patients (44 imiquimod, 40 surgery). Blinded reviewer assessments of lesion size and lesion severity showed improvement from baseline to follow-up, with no differences between treatment groups. Sexual pleasure, discomfort, and distress remained stable from baseline to follow-up in both groups. CONCLUSIONS: Good aesthetic outcome of vulvar high-grade squamous intraepithelial lesion treatment can be achieved with imiquimod and surgery, consisting of ablation or local excision. Treatment satisfaction and stable psychosexual health may not be dependent on chosen treatment modality, but rather on counseling in accordance with patients' preferences.

Topical imiquimod versus surgery for vulvar intraepithelial neoplasia: a multicentre, randomised, phase 3, non-inferiority trial.

BACKGROUND: The optimal management of vulvar high-grade squamous intraepithelial lesions (vHSILs) is challenging. Surgery is the standard treatment, but recurrences are observed in half of patients. Medical treatment with imiquimod is an effective alternative, but the two modalities have not been compared in a randomised trial. The aim of this study was to compare the clinical effectiveness, histological response, human papillomavirus (HPV) clearance, acceptance, and psychosexual morbidity of primary imiquimod treatment versus surgical treatment in women with vHSIL. METHODS: This study was a multicentre, randomised, phase 3, non-inferiority clinical trial done by the Austrian Gynaecological Oncology group at six hospitals in Austria. We recruited female patients aged 18-90 years with histologically confirmed vHSIL with visible unifocal or multifocal lesions. Main exclusion criteria were clinical suspicion of invasion, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, and any active treatment for vHSIL within the previous 3 months. Women with known immunodeficiency, who were pregnant, or who were lactating were excluded. Patients were randomly assigned (1:1) by block randomisation to imiquimod or surgery, and stratified by unifocal or multifocal disease. Treatment with imiquimod was self-administered in a slowly escalating dosage scheme up to three times per week for a period of 4-6 months. Surgery consisted of excision or ablation. Patients were assessed with vulvoscopy, vulvar biopsy, HPV tests, and patient-reported outcomes at baseline and after 6 months and 12 months. The primary endpoint was complete clinical response (CCR) at 6 months after local imiquimod treatment or one surgical intervention. Primary analysis was per protocol with a non-inferiority margin of 20%. This trial is registered at ClinicalTrials.gov, NCT01861535. FINDINGS: 110 patients with vHSIL (78% with unifocal vHSIL and 22% with multifocal vHSIL) were randomly assigned between June 7, 2013, and Jan 8, 2020. Clinical response to treatment could be assessed in 107 patients (54 in the imiquimod group and 53 in the surgery group), and 98 patients (46 in the imiquimod group and 52 in the surgery group) completed the study per protocol. 37 (80%) of 46 patients using imiquimod had CCR, compared with 41 (79%) of 52 patients after one surgical intervention, showing non-inferiority of the new treatment (difference in proportion -0·016, 95% CI -0·15 to -0·18; p=0·0056). Invasive disease was found in five patients at primary or secondary surgery, but not in patients with per-protocol imiquimod treatment. There was no significant difference in HPV clearance, adverse events, and treatment satisfaction between study groups. INTERPRETATION: Imiquimod is a safe, effective, and well accepted alternative to surgery for women with vHSIL and can be considered as first-line treatment. FUNDING: Austrian Science Fund and Austrian Gynaecological Oncology group.

ESGO/ESTRO/ESP Guidelines for the management of patients with cervical cancer - Update 2023.

In 2018, the European Society of Gynecological Oncology (ESGO) jointly with the European Society for Radiotherapy and Oncology (ESTRO) and the European Society of Pathology (ESP) published evidence-based guidelines for the management of patients with cervical cancer. Given the large body of new evidence addressing the management of cervical cancer, the three sister societies jointly decided to update these evidence-based guidelines. The update includes new topics to provide comprehensive guidelines on all relevant issues of diagnosis and treatment in cervical cancer.To serve on the expert panel (27 experts across Europe) ESGO/ESTRO/ESP nominated practicing clinicians who are involved in managing patients with cervical cancer and have demonstrated leadership through their expertise in clinical care and research, national and international engagement, profile, and dedication to the topics addressed. To ensure the statements were evidence based, new data identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Before publication, the guidelines were reviewed by 155 independent international practitioners in cancer care delivery and patient representatives.These updated guidelines are comprehensive and cover staging, management, follow-up, long-term survivorship, quality of life and palliative care. Management includes fertility sparing treatment, early and locally advanced cervical cancer, invasive cervical cancer diagnosed on a simple hysterectomy specimen, cervical cancer in pregnancy, rare tumors, recurrent and metastatic diseases. The management algorithms and the principles of radiotherapy and pathological evaluation are also defined.

Challenges in lower limb lymphoedema assessment based on limb volume change: Lessons learnt from the SENTIX prospective multicentre study.

BACKGROUND: Lower limb lymphoedema (LLL) is the most disabling adverse effect of surgical staging of pelvic lymph nodes. However, the lack of standardisation of volumetric LLL assessment hinders direct comparison between the studies and makes LLL reporting unreliable. The aim of our study is to report outcomes from a prospective trial that have implications for LLL assessment standardisation. METHODS: In the prospective international multicentre trial SENTIX, a group of 150 patients with stage IA1-IB2 cervical cancer treated by uterine surgery with bilateral sentinel lymph node biopsy was prospectively evaluated by objective LLL assessment, based on limb volume change (LVC) using circumferrential limb measurements and subjective patient-reported swelling. The assessments were conducted in six-month periods over 24 months post-surgery. RESULTS: Patient LVC substantially fluctuated in both positive and negative directions, which were comparable in frequency up to ±14% change. Thirty-eight patients experienced persistent LVC increase >10% classified as LLL, with nine months median time to onset. Some 34.2% of cases experienced onset later than one year after the surgery. Thirty-three patients (22%) experienced transient oedema characterised as LVC >10%, which resolved without intervention between two consequent follow-up visits. No significant correlation between LVC >10% and a patient-reported swelling was observed. CONCLUSIONS: Given that we observed comparable fluctuations of the the lower-limb volumes after surgical treatment of cervical cancer in both positive and negative direction up to ±14%, the diagnostic threshold for LLL diagnosis based on LVC should be increased to >15% LVC. The distinction of transient oedema from persistent LLL requires repeated measurements. Also, as one-third of LLL cases are diagnosed >1-year post-surgery, a sufficient follow-up duration needs to be ensured. Patient-reported swelling correlated poorly with LVC and should only be used as an adjunct to objective LLL assessment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02494063.

Preemptive local analgesia at vaginal hysterectomy: a systematic review.

INTRODUCTION AND HYPOTHESIS: We conducted a systematic review of the effectiveness of local preemptive analgesia for postoperative pain control in women undergoing vaginal hysterectomy. METHODS: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews were searched systematically to identify eligible studies published through September 25, 2019. Only randomized controlled trials and systematic reviews addressing local preemptive analgesia compared to placebo at vaginal hysterectomy were considered. Data were extracted by two independent reviewers. Results were compared, and disagreement was resolved by discussion. Forty-seven studies met inclusion criteria for full-text review. Four RCTs, including a total of 197 patients, and two SRs were included in the review. RESULTS: Preemptive local analgesia reduced postoperative pain scores up to 6 h and postoperative opioid requirements in the first 24 h after surgery. CONCLUSION: Preemptive local analgesia at vaginal hysterectomy results in less postoperative pain and less postoperative opioid consumption.

The Austrian Sacrocolpopexy Registry: Surgical Techniques, Perioperative Safety, and Complications.

STUDY OBJECTIVE: Sacrocolpopexy (SCP) has become the standard procedure to correct uterovaginal prolapse in women, but techniques and approaches are not standardized. We report the results of the Austrian Sacrocolpopexy Registry, which aimed to collect data on surgical techniques and perioperative outcomes. DESIGN: The Austrian Urogynecology Working Group initiated a registry to assess surgical variability and perioperative safety of SCP. The study was performed at 14 centers (13 in Austria,1 in Switzerland). Institutional review board approvals were obtained. PATIENTS: Consecutive patients with symptomatic pelvic organ prolapse (POP). INTERVENTIONS: SCP in the course of routine POP treatment. MEASUREMENTS AND MAIN RESULTS: Preoperative assessment included demographic data, clinical data on bladder, and bowel functions and POP-Q status. Surgical data included surgical approach (open, laparoscopic, robotic), type of mesh, depth of dissection, nerve sparing techniques, suture materials, uterus or cervix-sparing techniques, peritoneal closure, and concomitant surgeries. A total of 401 patients were recruited into the study. The mean age was 57 years (range: 26-84) and mean body mass index was 34. A total of 137 (34%) patients had undergone previous surgery for prolapse and in 264 cases SCP was the primary procedure. A total of 170 (42%) patients had undergone previous hysterectomy; For patients with uterus, SCP was performed with subtotal (n = 148) or total (n = 3) hysterectomy. A total of 285 (71%) SCPs were done laparoscopically, 102 (25%) robotically and 10 (3%) per laparotomy. The conversion rate from laparoscopy to abdominal surgery was 4.5%. Various meshes and suture materials were used and fixation techniques also varied widely. Four patients underwent reoperation within 30 days (2 trocar herniations, and 1 bowel obstruction, 1 compartment syndrome). One patient died of aortic dissection 7 days after SCP. CONCLUSIONS: Most SCPs in this registry were performed laparoscopically, but there was considerable variation in surgical techniques. Perioperative morbidity appears modest.

Guidelines for vulvar and vaginal surgery: Enhanced Recovery After Surgery Society recommendations.

This is the first collaborative Enhanced Recovery After Surgery Society guideline for optimal perioperative care for vulvar and vaginal surgeries. An Embase and PubMed database search of publications was performed. Studies on each topic within the Enhanced Recovery After Surgery vulvar and vaginal outline were selected, with emphasis on meta-analyses, randomized controlled trials, and prospective cohort studies. All studies were reviewed and graded according to the Grading of Recommendations, Assessment, Development and Evaluation system. All recommendations on the Enhanced Recovery After Surgery topics are based on the best available evidence. The level of evidence for each item is presented.

European Society of Gynaecological Oncology quality indicators for surgical treatment of cervical cancer.

BACKGROUND: Optimizing and ensuring the quality of surgical care is essential to improve the management and outcome of patients with cervical cancer.To develop a list of quality indicators for surgical treatment of cervical cancer that can be used to audit and improve clinical practice. METHODS: Quality indicators were developed using a four-step evaluation process that included a systematic literature search to identify potential quality indicators, in-person meetings of an ad hoc group of international experts, an internal validation process, and external review by a large panel of European clinicians and patient representatives. RESULTS: Fifteen structural, process, and outcome indicators were selected. Using a structured format, each quality indicator has a description specifying what the indicator is measuring. Measurability specifications are also detailed to define how the indicator will be measured in practice. Each indicator has a target which gives practitioners and health administrators a quantitative basis for improving care and organizational processes. DISCUSSION: Implementation of institutional quality assurance programs can improve quality of care, even in high-volume centers. This set of quality indicators from the European Society of Gynaecological Cancer may be a major instrument to improve the quality of surgical treatment of cervical cancer.

Psychometric properties and validation of two global impression questionnaires (PGI-S, PGI-I) for stress incontinence in a German-speaking female population.

AIMS: The Patient Global Index of Severity (PGI-S) and the Patient Global Index of Improvement (PGI-I) are global impression questionnaires developed in English and validated in women with stress urinary incontinence (SUI). This validation study tested the psychometric properties of German-language versions of the two questionnaires in German-speaking women with SUI. METHODS: The German-language PGI-S and PGI-I were psychometrically tested and validated using the SF-12 questionnaire, the Kinǵs Health Questionnaire (KHQ), clinical parameters, incontinence episode frequency and pad use in 311 patients before and 3 months after receiving a TVT-O or TVT tape for SUI. RESULTS: At baseline and 3 months postoperatively there was a positive correlation between PGI-S response categories and clinical parameters, IEF and pad use, and nearly all KHQ subscales. There were no correlations between response categories of PGI-S at baseline and PGI-I at 3 months and the SF-12 scales PCS-12 and MCS-12. CONCLUSION: Our results demonstrated good psychometric properties of the German-language PGI-S and PGI in German-speaking women with SUI.

Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

AIMS: To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. METHODS: A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). RESULTS: Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. CONCLUSIONS: At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare.

The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology Guidelines for the Management of Patients With Cervical Cancer.

BACKGROUND: Despite significant advances in the screening, detection, and treatment of preinvasive cervical lesions, invasive cervical cancer is the fifth most common cancer in European women. There are large disparities in Europe and worldwide in the incidence, management, and mortality of cervical cancer. OBJECTIVE: The European Society of Gynaecological Oncology (ESGO), the European Society for Radiotherapy and Oncology (ESTRO), and the European Society of Pathology (ESP) jointly develop clinically relevant and evidence-based guidelines in order to improve the quality of care for women with cervical cancer across Europe and worldwide. METHODS: The ESGO/ESTRO/ESP nominated an international multidisciplinary development group consisting of practicing clinicians and researchers who have demonstrated leadership and expertise in the care and research of cervical cancer (23 experts across Europe). To ensure that the guidelines are evidence based, the current literature identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the development group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 159 international reviewers, selected through ESGO/ESTRO/ESP and including patient representatives. RESULTS: The guidelines cover comprehensively staging, management, and follow-up for patients with cervical cancer. Management includes fertility sparing treatment; stage T1a, T1b1/T2a1, clinically occult cervical cancer diagnosed after simple hysterectomy; early and locally advanced cervical cancer; primary distant metastatic disease; cervical cancer in pregnancy; and recurrent disease. Principles of radiotherapy and pathological evaluation are defined.

Objective outcome and quality-of-life assessment in women with repeat incontinence surgery.

AIMS: To evaluate subjective and objective outcome after repeat surgery for stress urinary incontinence (SUI). METHODS: Patients who underwent a midurethral tape after failed Burch colposuspension or failed midurethal tape between 1999 and 2014 were invited for follow-up. Urogynecological examination and urodynamics was performed, and objective cure was defined as a negative cough stress test; subjective cure was defined as negotiation of SUI symptoms. Quality-of-life (QoL), sexual health, and subjective success was assessed with the King's Health Questionnaire, Incontinence Outcome Questionnaire, Female Sexual Function Index, and the Patient Global Impression of Improvement (PGI-I) score. RESULTS: Overall 52 women underwent repeat incontinence surgery. Out of the 44 women still alive, 33 (75%) were available for follow-up. All 33 women completed the questionnaires; 23 women (70%) attended the clinic and also had an urogynecological examination. At a median follow-up of 11 years, subjective cure was 67% (22/33), objective cure was 65% (16/23), and subjective success according to PGI-I was 78% (18/23), with no significant differences between groups. No erosions of suture or tape material into the bladder, urethra, or vagina were seen. Two women had received a third anti-incontinence operation with TVT after failed tape after failed Burch, and were continent at follow-up. Two women with tape after colposuspension required division of the tape and both were continent at the time of follow-up. With regard to QoL and sexual health, no significant differences were seen for most domains. CONCLUSIONS: Midurethral tapes are an option for women with recurrent SUI after previous colposuspension or midurethral tape.

Ten-Year Followup after Tension-Free Vaginal Tape-Obturator Procedure for Stress Urinary Incontinence.

PURPOSE: Suburethral tapes are a standard surgical treatment for stress urinary incontinence. The aim of the study was to evaluate subjective and objective cure rates 10 years after a tension-free vaginal tape-obturator procedure. MATERIALS AND METHODS: All 124 patients who underwent the tension-free vaginal tape-obturator procedure at a total of 2 centers in 2004 and 2005 were invited for followup. Objective cure was defined as a negative cough stress test at 300 ml. Subjects completed KHQ (King's Health Questionnaire), IOQ (Incontinence Outcome Questionnaire), FSFI (Female Sexual Function Index Questionnaire) and PGI-I (Patient Global Impression of Improvement). RESULTS: Overall, 55 of 112 women (49%) who were alive were available for clinical examination and 71 (63%) completed the questionnaires. The objective cure rate in the 55 women examined clinically was 69%, 22% were not cured and 9% (5) had undergone reoperation for recurrent or persistent stress urinary incontinence. Treatment was counted as having failed in these 5 women for study purposes. Subjective cure was reported by 45 of 71 women (64%). Three patients (5%) had vaginal tape extrusion at the time of clinical examination. Extrusion in all of them was small and asymptomatic, and did not require treatment for a cumulative extrusion rate of 7%. Six women (9%) had undergone reoperation for tension-free vaginal tape-obturator associated complications and 18 (26%) experienced de novo overactive bladder. CONCLUSIONS: Subjective and objective cure rates 10 years after the tension-free vaginal tape-obturator procedure were 69% and 64%, respectively. The vaginal extrusion rate in this study was slightly higher than in other series but major long-term complications appeared to be rare.

Reasons for dissatisfaction ten years after TVT procedure.

INTRODUCTION AND HYPOTHESIS: The aim of the study was to assess the reasons for dissatisfaction 10 years after TVT placement. METHODS: Patients who underwent TVT surgery between 1999 and 2001 at two participating units were included. All patients who did not consider themselves to be cured were asked for their reasons. RESULTS: 141 out of 210 patients (81 %) were available for follow-up (median 116 months). In the group of 56 patients who did not consider themselves cured, the reasons were OAB symptoms in 29 patients (52 %), stress urinary incontinence in 13 patients (23 %), and complaints of mixed urinary incontinence in 8 patients (14 %). 85 % of all patients reporting urgency complaints at the time of follow-up and 66 % of patients with SUI at the time of follow-up did not consider themselves cured. CONCLUSIONS: In most cases overactive bladder symptoms were the reason for dissatisfaction. The results of this study support using composite outcomes to assess the results of surgery for urinary incontinence.

Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial.

BACKGROUND: We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women. STUDY DESIGN: The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O. RESULTS: A total of 480 patients (85%) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87% of patients after TVT and in 84% after TVT-O; 64% and 59% of patients, respectively, reported no pad use, and 88% of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings' Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications. CONCLUSIONS: Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity.

OBJECTIVE: We sought to test the hypothesis that an extraperitoneal cesarean section (ECS) technique reduces postoperative pain without increasing intraoperative and postoperative complications. STUDY DESIGN: In a single-center, single-blinded prospective trial we randomized 54 patients with an indication for primary or first repeat cesarean section at term pregnancy to an ECS (n = 27) or transperitoneal cesarean section (TCS) (n = 27) procedure. Patients with suspected abnormal placentation, a history of >1 cesarean section, or major abdominal surgery were excluded. The primary endpoint of the study was maximum abdominal pain measured by numeric rating scale ranging from 0-10. RESULTS: Patients after ECS had significantly less maximum surgical site pain than patients after TCS. Median peak pain scores on postoperative day 1 were 4.00 (interquartile range, 3.00-5.00) for ECS and 5.00 (interquartile range, 4.00-7.00) for TCS, respectively (P = .031). Analgesic requirements, intraoperative nausea, and postoperative shoulder pain were significantly less after ECS. Overall operative time was significantly shorter in ECS, with no difference in delivery time. No bladder injury occurred in either group. There were no differences in estimated blood loss and neonatal outcome. Urogenital distress, urinary tract infection, and bowel dysfunction did not differ at discharge from hospital and 6 weeks after. CONCLUSION: An extraperitoneal approach to cesarean section appears to reduce postoperative pain, usage of analgesics, and intraoperative nausea without an increase in significant complications.

Voiding dysfunction after colpectomy and urethral lengthening in transgender men.

Background: Colpectomy is a frequent part of gender-affirming surgery in transgender men. Urologic complications with these procedures can complicate and delay further management. Aim: We reviewed the rate of postoperative voiding dysfunction after colpectomy with urethral lengthening in transgender men. Methods: We reviewed postoperative voiding in 47 transgender men (age, 19-50 years) who underwent colpectomy with urethral lengthening. Thirty-eight patients (81%) had undergone hysterectomy (36 total, 2 subtotal/supracervical) previously and 11 (23%) underwent concomitant hysterectomy or removal of the residual cervix (4 abdominal, 6 laparoscopic, 1 transvaginal). Colpectomy was done transvaginally by opening and developing laterally the vesicovaginal and rectovaginal spaces and then transecting the lateral vaginal attachments with bipolar vessel sealing. Urethral lengthening with an anterior vaginal flap was performed in the same procedure as colpectomy. A transurethral catheter was left in situ for 14 days postoperatively. Voiding dysfunction was defined as failure of spontaneous micturition after removal of the catheter at 14 days. Results: 40/47 (85%) patients were able to void after catheter removal, 7 (15%) were not. Voiding dysfunction occurred in 3/11 (27%) patients undergoing concomitant hysterectomy or removal of a residual cervix and in 4/36 patients (11%) status post total hysterectomy. Voiding dysfunction persisted for a median of 3 months (2 days - 46 months). Conclusions: In this series voiding dysfunction developed in 15% of transgender men undergoing colpectomy with urethral lengthening and appeared to be more common in patients undergoing concomitant hysterectomy or removal of a residual cervix than in those status post hysterectomy. Patients should be counseled accordingly.

Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial.

BACKGROUND: Urogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion. STUDY DESIGN: We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires. RESULTS: Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy. CONCLUSIONS: Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens. CLINICALTRIALS: gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735.

Enhanced recovery after cesarean section (ERAC): Where are we in Austria?

OBJECTIVE: Enhanced recovery after surgery (ERAS) recommendations for cesarean section (ERAC), likely the most common reason for laparotomy in women, were issued in 2018-19. We examined how current perioperative management at cesarean section in Austrian hospitals aligns with ERAS recommendations. STUDY DESIGN: We surveyed the 21 largest public obstetric units in Austria for alignment with 20 of the 31 strong ERAS recommendations regarding perioperative maternal care at cesarean section. We also looked at how the German-language clinical guideline for cesarean section (AWMF Guideline Sectio caesarea) aligns with ERAS recommendations. RESULTS: The 21 obstetric units cared for about 51% of all births in Austria in 2019. Cesarean section rates ranged from 17.7% to 50.4%. All 21 units implemented the five strong recommendations regarding patient information and counselling, regional anesthesia, euvolemia and multimodal analgesia. The least implemented strong recommendation was the one for the use of pneumatic compression stockings to prevent thromboembolic disease (0/21 units). Overall, all 21 units implemented ≥11 and 13 (62%) implemented ≥15 (≥75%) of the 20 strong recommendations; no unit implemented all 20 strong recommendations. There were no differences in the implementation of strong recommendations according to hospital volume. CONCLUSIONS: Even in the absence of formal adoption of ERAS program for cesarean section many perioperative ERAS recommendations are already implemented in Austria. The least implemented recommendations were the use of pneumatic compression stockings (0 of 21 units) and immediate catheter removal (4 of 21 units). Only 10 of the 20 ERAS recommendations we looked at are included in the current German-language clinical guideline for cesarean section.