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Recurrence rate after hysteroscopic adhesiolysis can be as high as 60%. This RCT aimed to assess the effectiveness of a new intrauterine mechanical barrier film in the management of IUA. PREG2 is a double-blind randomized, controlled, stratified study. 16 sites in Europe and China. Patients scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (AFS score ≥ 5). Following adhesiolysis, patients were randomized to either have a Womed Leaf film inserted or not. Womed Leaf (Womed SAS, France) is a degradable polymer film that expands to fill the entire cavity and acts as a mechanical barrier between the uterine walls. After about a week, it degrades and is discharged naturally. Hormonal treatment was authorized in both groups. Patients were scheduled for second-look hysteroscopy (SLH) after 4 to 8 weeks. The effectiveness endpoints were: Change in AFS score between baseline and SLH, responder rate (i.e. patients who improved of at least two clinical categories, e.g. from severe to mild or from moderate to no IUA) and absence of IUA at SLH. The patient and the SLH evaluator were blind. 160 women were randomized. The reduction in AFS score at SLH was significantly higher in the intervention compared to the control group (5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). The responder rate was significantly higher in the intervention group (51% vs 29% OR 2.7 [1.4–5.5]; p=0.0052). The absence of adhesions at SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device. This large RCT of patients with severe or moderate IUA demonstrated the effectiveness of Womed Leaf. It is the first adhesion barrier to show any clinically meaningful improvement in this challenging indication. [ABSTRACT FROM AUTHOR]

Study Objective: To compare nifedipine, naproxen, or placebo for pain relief during diagnostic hysteroscopy., Design: Double-blind, randomized controlled pilot study., Setting: University hospital., Patients: Women scheduled for office diagnostic hysteroscopy (n = 60)., Interventions: Women received nifedipine (2 tablets of 10 mg), naproxen (2 tablets of 250 mg), or placebo (2 tablets of 500 mg lactose) 30 to 60 minutes prior to hysteroscopy., Measurements and Main Results: Sixty patients were enrolled in the study (21 in the nifedipine group, 19 in the naproxen group, and 20 in the placebo group). The median pain scores during hysteroscope insertion, measured on a Visual Analog Scale (VAS), were 1 (interquartile range (IQR) 0-0), 2 (0-4) and 1 (0-1) in the nifedipine, naproxen and placebo group, respectively (P,14). The median VAS scores during hysteroscopy were 5 (IQR 2-7), 5 (4-8) and 5 (3-7) in the nifedipine, naproxen and placebo group, respectively (P,73). The median VAS scores immediately after hysteroscopy were 2 (IQR 0-4), 3 (0-6) and 3 (1-5) in the nifedipine, naproxen and placebo group, respectively (P,40). The median VAS scores 30 minutes after hysteroscopy were 1 (IQR 0-2), 1 (0-1) and 1 (0-2) in the nifedipine, naproxen and placebo group, respectively (P,63). Hysteroscope insertion failed in 1 case (naproxen group) because of cervica`l stenosis (P,32). Flushes, fatigue and vertigo, 30 minutes after the procedure, were significantly more prevalent in the nifedipine group compared to the naproxen (p < .001, p,03, p,03, respectively) and the placebo group (p < .001, p,01, p,01, respectively). Palpitations occurred only in the nifedipine group (p < .001). The day after the procedure, the headache was most prevalent in the nifedipine group compared to the naproxen group (p,001) and the placebo group (p,001)., Conclusion: In our pilot study, pain relief and success rates for office diagnostic hysteroscopy were not significantly different between nifedipine, naproxen, and placebo. Nifedipine was associated with more, albeit tolerable, side-effects., (Copyright © 2023 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To evaluate the safety and potential efficacy of a novel degradable polymer film (DPF) designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs) after hysteroscopic myomectomy., Design: A prospective single-arm, first-in-human clinical study., Setting: Multicenter study involving 6 centers in France, Belgium, and the Netherlands., Patients: Women aged 40 years or older with no plans to conceive who qualified for hysteroscopic myomectomy (at least 1 10-mm type 0, 1, or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 cm and 9 cm were considered eligible for the study., Interventions: The DPF was inserted after hysteroscopic transcervical myoma resection. The women were followed up by a telephone call at 30 days and second-look hysteroscopy 4 to 8 weeks after the procedure., Measurements and Main Results: The chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain, or bleeding beyond 48 hours and up to 30 days after insertion, whereas the outcome measure for efficacy was the absence of IUAs on second-look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported adverse effects attributable to the DPF. On second-look hysteroscopy, 20 (87%) of the 23 women had no IUAs., Conclusion: The DPF is a novel, easy-to-apply, and acceptable device to prevent IUAs, with very promising initial safety and efficacy data., (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To evaluate the reproductive outcomes in women treated for retained products of conception (RPOC) by hysteroscopy (morcellation vs loop resection)., Design: Cohort study., Setting: A teaching and university hospital., Patients: Patients included in a previous randomized controlled trial on hysteroscopic removal of RPOC comparing morcellation (n = 46) with loop resection (n = 40)., Interventions: Hysteroscopic morcellation versus loop resection., Measurements and Main Results: The primary outcome measures were live birth and pregnancy complications (including abnormal placentation [placenta accreta/increta/percreta], placenta previa, vasa previa, retained placenta after delivery or incomplete expulsion with the need for manual removal or curettage, and RPOC), uterine rupture, and other complications (blood loss, preterm labor, preterm premature rupture of membranes, hypertensive disorders of pregnancy, and intrauterine growth restriction). The live birth rate was 88.9% in the morcellation group and 68.2% in the loop resection group (p = .09). Uterine rupture occurred in 1 patient in the morcellation group (4.2%) (p = 1.00). Placental complications were found in 20.8% and 22.2% of the hysteroscopic morcellation and loop resection groups, respectively (p = .33), and other pregnancy complications were seen in 33.3% and 16.6% of the 2 groups (p = .33). The secondary outcome was time to pregnancy. The median time to pregnancy was 14 weeks (interquartile range [IQR], 5-33 weeks) in the morcellation group and 15 weeks (IQR, 6-37 weeks) in the loop resection group (p = .96)., Conclusion: Hysteroscopic removal of RPOC seems to have no detrimental effect on reproductive outcome and no significant effect on pregnancy rate., (Copyright © 2019 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To compare hysteroscopic morcellation with loop resection for the removal of placental remnants in terms of procedure time, adverse events, tissue availability, histology results, short-term effectiveness, and postoperative adhesions., Design: A randomized controlled trial (Canadian Task Force classification I)., Setting: A teaching and university hospital., Patients: Women with placental remnants., Interventions: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System (Smith & Nephew, Inc, Andover, MA) or loop resection with a rigid 8.5-mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany)., Measurements and Main Results: Forty-six and 40 women were included in the hysteroscopic morcellation and resection groups, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with loop resection (6.2 minutes [interquartile range, 4.0-11.2 minutes] vs 10.0 minutes [5.8-16.4 minutes], p = .023). Both operating time and total procedure time, corrected for the diameter of the placental remnants, were significantly reduced for hysteroscopic morcellation compared with loop resection, by 40% (95% confidence interval, 15%-58%; p = .005) and 22% (95% CI, 5%-37%; p = .014), respectively. No adverse events occurred during hysteroscopic removal. Perforation at dilation in 8 cases of the hysteroscopic morcellation group resulted in 2 procedure discontinuations and 1 incomplete procedure. Incomplete removal was found in 1 uncomplicated hysteroscopic morcellation procedure and 2 resection procedures. Pathology results confirmed the presence of placental remnants in 27 of 40 (67.5%) and 26 of 37 (70%) patients in the hysteroscopic morcellation and resection groups, respectively. Second-look hysteroscopy showed de novo intrauterine adhesions in 1 of 35 patients (3%) in the hysteroscopic morcellation group and 1 of 30 (3%) patients in the resection group., Conclusion: Hysteroscopic morcellation is a faster alternative than loop resection. Both techniques are safe and show high rates of complete removal and tissue availability and low rates of de novo intrauterine adhesions., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objectives: To compare hysteroscopic morcellation with bipolar resectoscopy for removal of endometrial polyps, in terms of procedure time, peri- and postoperative adverse events, tissue availability, and short-term effectiveness., Design: Multicenter, open label, randomized controlled trial (Canadian Task Force classification I)., Setting: Day surgery setting of a teaching and a university hospital., Patients: Women with larger (≥1 cm) endometrial polyps., Interventions: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System or bipolar resectoscopy with a rigid 8.5-mm bipolar resectoscope., Measurements and Main Results: Eighty-four women were included in the intention-to-treat analysis. Median operating time was 4.0 min (range: 2.5-7.1) and 6.0 min (range: 3.8-11.7) in the hysteroscopic morcellation and resectoscopy groups, respectively. Operating time was reduced by 38% (95% confidence interval: 5%-60%; p = .028) in the hysteroscopic morcellation group. Procedure time, which was defined as the sum of the installation and operating time, tended to be less for the hysteroscopic morcellation group (median 9.5 min [range: 7.6-12.2] vs 12.2 min [range: 8.8-16.0]; p = .072). Perforation occurred at dilation or hysteroscope (re)introduction in 3 patients of the resectoscopy group, resulting in procedure discontinuation or prolongation of hospital stay. Perforation occurred at dilation in 1 patient in the hysteroscopic morcellation group; however, the procedure was successfully completed. Postoperatively, 2 patients of the hysteroscopic morcellation group were diagnosed with a urinary tract infection. Tissue was available for pathology analysis in all patients, except for 2 patients in the resectoscopy group in whom the procedure was discontinued due to perforation., Conclusion: Hysteroscopic morcellation is a fast, effective, and safe alternative to bipolar resectoscopy for removal of endometrial polyps., (Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.)