Autologous mesenchymal stem cell therapy for diabetic men with erectile dysfunction. Is it promising? A pilot study.

PURPOSE: to assess safety and efficacy of autologous mesenchymal bone marrow stem cell injection in penile cavernosal tissue for erectile dysfunction therapy in diabetic men. METHODS: The subjects of this study were diabetic men suffering erectile dysfunction, non-responding to maximum dose of oral PDE5I. Mesenchymal bone marrow stem cells were aspirated and injected after preparation in both corpora cavernosa at 3, 9 o'clock position. Erectile function was assessed by the International Index of Erectile Function and penile Doppler study, before and after 6 months after injection. RESULTS: 4 patients out of 10 achieve hard erection adequate for satisfactory coitus, and 2 patients achieved penile hardness with addition of pharmacological therapy with sildenafil 100mg. Peak systolic velocity increased significantly in 4 patients (2 arteriogenic and 2 mixed erectile dysfunction), from 12∼22 cm/s to 32∼69 cm/s. Variations in end-diastolic velocity increased substantially in 2 patients with venogenic insufficiency alone at follow-up from 4∼5 cm /s to -4∼-3 cm/s. CONCLUSIONS: Despite promising stem cell treatment efficacy for patients with erectile dysfunction, more clinical studies and researches are still warranted.

Fetal echocardiographic parameters in pregnancies complicated by diabetes: a case control study.

BACKGROUND: At present, the prevalence of pregestational diabetes is 2.2% with an overall prevalence of hyperglycaemia in pregnancy of about 16.2%. Fetuses of diabetic mothers are at risk of functional cardiac abnormalities without structural cardiac anomalies especially in the third trimester. The main aim of this study was to assess the association of diabetes with different fetal echocardiographic parameters. METHODS: A case control study comprising a total of 120 pregnant women (60 cases and 60 controls). The cases group included fetuses of mothers known to have pre-gestational type 2 diabetes (DM group) while the control group included fetuses of euglycaemic healthy pregnant women. They were examined twice at 23-24 weeks' gestation (visit 1) and followed up at 27-28 weeks' gestation (visit 2). The Modified Myocardial Performance Index (Mod MPI) was obtained in all fetuses. Also, M-mode echocardiography was used to measure the interventricular septum thickness at diastole in a transverse four chamber view. RESULTS: There was a significant increase in Iso-volumetric contraction time (ICT) (45.4 ms ± 8.9), Iso-volumetric relaxation time (IRT) (54.7 ms ± 11.22), Interventricular septal thickness (IVST) (4.08 mm ± 0.8), aortic acceleration time (AAT) (54.16 ms ± 12.77) and MPI (0.64 ± 0.09) in the diabetic group compared to the normal control group ICT (38.5 ms ± 9.59), IRT (46.13 ms ± 10.29), IVST (3.17 mm ± 0.6), AAT (49.73 ms ± 10.68) and MPI (0.5 ± 0.1) (all P values were < 0.001). When comparing parameters assessed at both visits among diabetic patients, there was a significant increase in IVST in the second visit (4.74 ± 0.78 mm) compared to the first visit (4.08 ± 0.8 mm) (P value < 0.05). The incidence of hypertrophic cardiomyopathy (HCM) was significantly higher in diabetic patients than in the control group. This is was observed in both first and second visit (33.4% and 56.7%) (P value < 0.001). CONCLUSIONS: Fetuses of diabetic pregnant females show a significant increase in MPI, decrease in E\A ratio and HCM. These alterations in cardiac functions and structure were found to be continuous throughout the period of time between the two visits.

Hysteroscopic management versus ultrasound-guided evacuation for women with first-trimester pregnancy loss, a randomised controlled trial.

OBJECTIVE: We aimed to evaluate the hysteroscopic management of first-trimester pregnancy loss compared to surgical evacuation either blind or under ultrasonographic guidance . METHODS: This clinical trial included 315 women with first-trimester pregnancy loss, divided equally into three groups. Group 1 underwent traditional blind surgical evacuation, group 2 underwent ultrasound-guided evacuation, and group 3 underwent hysteroscopic management. All women were assessed for retained products, surgical complications, the need for further management, and pregnancy occurrence after evacuation within 2 years of follow up. RESULTS: The rate of presence of conception remnants and the need for further treatment was significantly higher in group 1 compared to groups 2 and 3 (4.8% vs. 0% vs. 0%, P = 0.012). The conception rate within 2 years was significantly lower in group 1 compared to groups 2 and 3 (57.4% vs. 73.2% vs. 82.7%, P = 0.002), and the duration needed to conceive was significantly prolonged in group 1 compared to groups 2 and 3 (9.8 vs. 8.3 vs. 6.9 months, P < 0.001). Interestingly, women who underwent hysteroscopic management needed a significantly shorter time to conceive than those who underwent ultrasound-guided evacuation (6.9 vs. 8.3 months, P = 0.006). CONCLUSIONS: Hysteroscopic management of first-trimester pregnancy loss was superior to ultrasound-guided surgical evacuation regarding the time interval to conceive. Both techniques were superior to the blind evacuation technique regarding removal of the whole conception remnants, need for further treatment and fertility outcomes. Clinical trial registration: It was first registered at ClinicalTrials.gov on 16/03/2017 with registration number NCT03081104.

Comparative efficacy of lidocaine-prilocaine cream and vaginal misoprostol in reducing pain during levonorgestrel intrauterine device insertion in women delivered only by cesarean delivery: A randomized controlled trial.

OBJECTIVE: To compare efficacy of lidocaine-prilocaine (LP) cream versus misoprostol versus placebo before levonorgestrel-releasing intrauterine device (LNG-IUD) insertion. METHODS: This randomized controlled trial (RCT) was conducted in a tertiary referral hospital from April 30, 2020 to March 1, 2021 on 210 parous women willing to receive LNG-IUD and delivered only by elective cesarean delivery (CD). Participants received 200 µg vaginal misoprostol or 5 ml of LP cream 5% or placebo 3 h before LNG-IUS insertion. Primary outcome was pain during LNG-IUD insertion, while secondary outcomes were pain 10 min post-procedure, ease of insertion, patient satisfaction, insertion time, and drug side effects. RESULTS: Pain during LNG-IUS insertion was reduced in LP group and misoprostol group compared to placebo group (2.1 ± 1.0 vs 3.7 ± 1.6; p <0.001) and (2.3 ± 1.3 vs 3.7 ± 1.6; p <0.001), respectively. Ease of procedure and patient satisfaction were significantly higher in LP and misoprostol groups than placebo (P <0.001). Need for additional analgesia was significantly higher in placebo group than in the other two groups (P = 0.009). Adverse events were not significantly different between the three groups except vomiting and abdominal cramps, which were higher with misoprostol. CONCLUSION: LP cream and 200 µg of vaginal misoprostol administration before LNG-IUD insertion in women delivered only by elective CD effectively reduced pain during insertion and 10 min post-procedure with easier insertions, high patient satisfaction, and tolerable side effects. Pain reduction with LP cream was clinically significant.

Delayed versus early pushing during the second stage of labour in primigravidas under epidural anaesthesia with occipitoposterior malposition: a randomised controlled study.

This randomised controlled trial aimed to compare the effect of early and delayed pushing during the second stage of labour in women with occipitoposterior (OP) malposition. It included 184 nulliparous women with OP position randomised to early pushing in which women were allowed to push within one hour after full cervical dilatation or delayed pushing in which women were asked not to push for maximum of three hours or start pushing when the vertex was visible. The primary outcome was successful vaginal delivery. The rate of spontaneous vaginal delivery was significantly higher in the early pushing group (80.4 vs. 60.9%, p=.004) while the rate of instrumental vaginal delivery (30.4 vs. 15.4%) and CS (8.7 vs. 4.3%) was significantly higher in the delayed pushing group. Women in the delayed pushing group showed a significantly longer duration of the second stage (129.4 ± 7.5 vs. 61.6 ± 15.3 minutes, p<.001) and shorter duration of pushing (219.8 ± 74.8 vs. 693.9 ± 145.2 seconds, p<.001) .The rate of 2nd and 3rd degree perineal lacerations (19.6 and 13% vs. 5.4 and 8.7% respectively, p=.013) and vaginal tears (41.3 vs. 8.7%, p<.001) was significantly higher in the early pushing group. We concluded that early pushing during the second stage of labour is associated with higher rates of spontaneous vaginal delivery and vaginal and perineal lacerations.Clinical trial registration NCT03121274.Impact StatementWhat is already known on this subject? Occipitoposterior malposition is common during delivery especially in primigravida and is associated with higher rates of instrumental delivery and caesarean section. It can be managed through early or delayed pushing.What the results of this study add? Early pushing is associated with higher rates of spontaneous vaginal delivery, perineal and vaginal tears, shorter duration of second stage of labour, shorter duration of pushing, lower rates of both instrumental vaginal delivery and caesarean section.What the implications are of these findings for clinical practice and/or further research? Early pushing during the second stage of labour is associated with higher rates of spontaneous vaginal delivery and vaginal and perineal lacerations in women with OP malposition and should be tried and not delaying the pushing.

The value of ultrasound guidance during IUD insertion in women with RVF uterus: A randomized controlled trial.

OBJECTIVE: The study objective is to evaluate the benefits of using ultrasound guidance during insertion of Intrauterine device IUD in women with retroverted flexed RVF uteri. STUDY DESIGN: A randomized controlled trial conducted on 400 women with RVF uteri eligible for IUD insertion. They were randomly divided into 2 groups. Group 1 underwent IUD insertion under ultrasound guidance while in group 2 no ultrasound guidance was used. The primary outcome measure was the(Visual Analogue Scale) VAS pain score reported by the women during insertion. Other outcome included easiness of insertion, the procedure time and occurrence of complications as nausea, vomiting, abdominal cramps, failure of insertion, uterine perforation and bleeding. RESULTS: The VAS pain score was significantly lower (2.36 ± 1.77 vs. 4.74 ± 2.35, p < 0.001), the insertion was much easier (score 4.0 ± 0.9 vs. 2.5 ± 1.27, p < 0.001) and the time needed for the procedure was significantly shorter (5.82 ± 2.56 vs. 9.4 ± 4.99 min, p < 0.001) in women within the ultrasound guided group when compared to control group. The total rate of complications was significantly lower (6 vs. 16 %, p 0.001) especially bleeding (2 vs. 9%, p = 0.002), abdominal cramps (10.5 vs. 28 %, p 0.012) and failure of the procedure (0 vs. 3%, p = 005) in ultrasound guided group women when compared to control. CONCLUSION: Insertion of Intrauterine device IUD under ultrasound guidance in women with Retroverted flexed RVF uterus easier and less painful than the blind standard technique.

Replantation of Nine Fingers in a Patient: A case report.

Amputation of multiple fingers of both hands is a rare and serious injury. We report a case of a 41-year-old male patient who presented to Khoula Hospital, Muscat, Oman, in 2015 with the amputation of nine fingers due to a workplace injury. With two teams working in tandem, all the amputated fingers were re-attached. A total of seven fingers survived and the patient regained reasonable functionality of his hands. To the best of the authors' knowledge, this is the first case of several finger amputations in Oman.

Urine test for HPV genotypes as a predictor of precancerous cervical lesions and for cervical cancer screening.

OBJECTIVE: To assess the sensitivity of a urine test for high-risk HPV DNA genotypes in the detection of high-grade squamous intra-epithelial lesion (HSIL) and its correlation with pathologic precancerous lesions. METHODS: The present prospective cross-sectional study included women referred to Kasr AlAiny Medical School, Cairo, Egypt, for cervical smear anomalies, a history of cervical smear anomalies, or for suspicious cervix between May 1, 2015, and April 30, 2017. Paired urine tests and cervical smears were performed. HPV DNA was detected in urine using polymerase chain reaction and cervical smears were performed with a cervical spatula and a cytobrush. Agreement between urine test results and pathology was examined. RESULTS: In total, 1375 women were included. Urine test for high-risk HPV DNA demonstrated 97.8% (95% confidence interval [CI] 92.1%-99.7%) sensitivity and 100% (95% CI 99.7%-100.0%) specificity for HSIL. Overall, 87 women had a positive urine test for high-risk HPV; of these, 82 (94.3%, 95% CI 87.1%-98.1%) had pathologic findings of cervical intra-epithelial neoplasia 2 or 3 (CIN2/3). Similarly, 89 women had HSIL cytology; again, 82 had CIN2/3 (92.1%; 95% CI, 84.3%-96.4%). CONCLUSION: There was good agreement between a positive urine test for high-risk HPV DNA genotypes and pathologic findings of CIN2/3.

Manual removal versus spontaneous delivery of the placenta at cesarean section in developing countries: a randomized controlled trial and review of literature.

PURPOSE: Cesarean section (CS) rates have increased; this is especially concerning in developing countries. The mode of placental delivery contributes to morbidity associated with CS and determines blood loss during CS. We aimed to compare manual removal versus spontaneous delivery of the placenta at CS. METHODS: In a randomized controlled trial, 574 women admitted for primary or repeat elective CS were randomized into two groups. In group A, the placenta was manually removed, whereas in group B, the placenta was left for spontaneous delivery. Blood loss, operative and postoperative data were recorded. RESULTS: Blood loss was 875.2 ± 524.2 ml in group A versus 731.8 ± 426.7 ml in group B (p = .001), with a significant drop in postoperative HB (p = .015) and HCT (p = .031). In group A, odds ratios for blood loss (>1000 ml), HB drop (> 4g/dl), postpartum hemorrhage and blood transfusion were 2.581, 2.850, 2.614 and 1.665, respectively. However, the total operative time (p = .326), duration of hospital stay (p = .916) and intensive care unit (ICU) admission (p = .453) were not statistically different between the two groups. CONCLUSIONS: Manual removal of the placenta at CS is associated with a higher risk of blood loss, postpartum hemorrhage and blood transfusion, with no decrease in operative time.

Effect of intramural fibroid on uterine and endometrial vascularity in infertile women scheduled for in-vitro fertilization.

PURPOSE: To study the effect of intramural fibroids on uterine and endometrial vascularity in infertile women scheduled for in-vitro fertilization (IVF). METHODS: 3D power Doppler was used to measure the endometrial volume and blood flow indices in 182 women with intramural fibroids not affecting the uterine cavity and compared them to a matched control group without fibroids. RESULTS: There was significantly increased vascularity in the endometrium of the fibroid group as denoted by higher endometrial VI (p = 0.018), FI (p = 0.027) and Endometrial VFI. No significant difference in mean uterine artery RI (p = 0.277) or PI (p = 0.187). Among the fibroid group 62.6% had a fibroid > 4 cm. Women with fibroids > 4 cm had a significantly higher Endometrial FI (p = 0.037), and VFI (p = 0.02). Uterine artery blood flow was not affected, as uterine RI (p = 0.369) and PI (p = 0.321) were not statistically different. Compared with the control group (non fibroid), women with fibroids > 4 cm had significantly higher endometrial VI (p = 0.013), FI (p = 0.004), and VFI (p < 0.001), whereas women with fibroid ≤ 4 cm had no statistically significant differences in VI (p = 0.292), FI (p = 0.198), and VFI (p = 0.304). CONCLUSION: Intramural fibroids > 4 cm significantly increase endometrial vascularity. This increase in blood flow may be a factor that affects the outcome of IVF.

Prevalence and diagnostic accuracy of Doppler ultrasound of placenta accreta in Egypt.

OBJECTIVE: The objective of this study is to assess the prevalence of placenta accrete (PA) among those with placenta implanted over cesarean section (CS) scar and to evaluate the accuracy of Doppler ultrasound in diagnosis. METHODS: A cross-sectional study included 100 patients with placenta previa (PP) anterior with at least one previous CS. Ultrasound and color Doppler were done to all participants and correlated with operative findings. RESULTS: There was a significant difference between accrete and non-accrete group regarding maternal age (32.6 ± 5.01 versus 29.14 ± 4.89), and a highly significant difference regarding the postoperative hemoglobin (6.71 ± 1.156 versus 8.41 ± 1.257) and the number of previous CSs (p <.001). The abnormal Doppler findings showed a highly significant difference between the two groups as loss of retroplacental clear zone (87.3% versus 10.8%), intraplacental lacunae (93.7% versus 37.8%), hypervascularity in uterine bladder interface (47.6% versus 5.4%), and blood vessels invading myometrium (82.5% versus 18.9%) (p < .001). The sensitivity, specificity, PPV, NPV, and accuracy of loss of retroplacental clear were 87.3%, 89.19%, 93.2%, 80.49%, and 88%; intraplacental lacunae were 93.65%, 62.16%, 80.82%, 85.19%, and 82%; hypervascularity in uterine bladder interface were 47.62%, 94.59%, 93.75%, 51.47%, and 65%; dilated vessels over peripheral subplacental zone were 82.54%, 81.08%, 88.14%, 73.17%, and 82%, respectively. There was a highly significant difference between the two groups regarding surgical management with cesarean hysterectomy, occurrence of bladder injury, the need for intraoperative, and postoperative blood transfusion, ICU admission (p < .001). CONCLUSION: The use of ultrasound together with the color Doppler allowed for better prediction of placental invasion of the myometrium prior to obstetrical intervention to improve the maternal and the fetal outcome.

Effect of oral contraceptives on balance in women: A randomized controlled trial.

OBJECTIVE: To detect the effect of combined oral contraceptive pills (COC) on dynamic postural balance in healthy middle aged women. MATERIALS AND METHODS: A prospective randomized controlled study included 200 patients classified into two groups. Group I received COC containing 30 µg of EE and 3 mg of drospirenone for 12 consecutive cycles and Group II received no treatment. Overall, medio-lateral and antero-posterior stability were measured using Biodex system after 12 months. RESULTS: There was a highly statistically significant difference between the 2 study groups regarding estradiol level (12.84 ± 1.96 vs. 38.86 ± 3.99, P value < 0.001) and progesterone level (0.52 ± 0.25 vs. 11.64 ± 4.53, P value < 0.001). There was a highly statistically significant difference between the 2 study groups regarding mediolateral stability (1.84 ± 0.23 vs. 2.40 ± 0.56, P value < 0.001), antereoposterior stability (1.91 ± 0.29 vs. 2.33 ± 0.61, P value < 0.001) or overall stability (2.42 ± 0.29 vs. 2.95 ± 0.53, P value < 0.001). CONCLUSION: COC are effective method of contraception to improve postural balance and decrease risk of injury in normal and athletic women. NCT02855294.

Maternal serum homocysteine and uterine artery Doppler as predictors of preeclampsia and poor placentation.

PURPOSE: The aim of this study was to evaluate the role of maternal serum total Homocysteine (tHcy) and uterine artery (Ut-A) Doppler as predictors of preeclampsia (PE), intrauterine growth restriction (IUGR), and other complications related to poor placentation. PATIENTS AND METHODS: A prospective cohort study was conducted on 500 women with spontaneous pregnancies. tHcy was measured at 15-19 weeks, and then, Ut-A Doppler was performed at 18-22 weeks of pregnancy. RESULTS: 453 pregnant women completed the follow-up of the study. The tHcy and Ut-A resistance index were significantly higher in women who developed PE, IUGR, and other complications when compared to controls (tHcy: 7.033 ± 2.744, 6.321 ± 3.645, and 6.602 ± 2.469 vs 4.701 ± 2.082 µmol/L, respectively, p value <0.001 and Ut-A resistance index: 0.587 ± 0.072, 0.587 ± 0.053, and 0.597 ± 0.069 vs 0.524 ± 0.025, respectively, p value <0.001). The use of both tHcy assessment and Ut-A Doppler improved the sensitivity of prediction of PE relative to the use of each one alone (85.2 relative to 73.33 and 60%, respectively). CONCLUSION: The use of elevated homocysteine and uterine artery Doppler screening are valuable in prediction of preeclampsia, IUGR, and poor placentation disorders. CLINCALTRIAL. GOV ID: NCT02854501.

The role of prophylactic use of low dose aspirin and calheparin in patients with unexplained recurrent abortion.

OBJECTIVE: To study the effect of prophylactic use of low dose aspirin and heparin on patients with recurrent unexplained pregnancy loss. METHODS: Prospective case control study conducted on 180 pregnant women randomized into two equal groups. Group 1 received low-dose aspirin 75 mg and heparin 5000 IU subcutaneous every 12 h. Group 2 received no treatment. RESULTS: There was a statistically significant difference between the two study groups regarding number of patients who completed their first trimester (66 versus 39) (p values 0.018). The outcome regarding completion of first trimester was not related to age, BMI or number of previous abortions in both the study groups. Complications of the use of aspirin calheparin occurred in 60% of the patients. The most common complication was bruising at injection site occurring in 60% of the patients followed by bleeding gums (14.4%), gastrointestinal troubles (12.2%), epistaxis (10%) and transient thrombocytopenia in only 2.22% of the patients (Table 4). CONCLUSION: The use of prophylactic dose of calheparin and aspirin is associated with increased chance of passing 1st trimester safely regardless the age, body mass index or number of abortion in women with unexplained recurrent spontaneous abortion.

Value of the serum estradiol level for preventing ovarian hyperstimulation syndrome: a retrospective case control study.

OBJECTIVE: To assess the value of different serum E(2) cut-off levels for predicting women at risk for ovarian hyperstimulation syndrome (OHSS). DESIGN: Retrospective case-control study of a cohort of women undergoing assisted reproduction treatment (ART) over 12 months. SETTING: Tertiary university hospital. PATIENT(S): The study group included women with OHSS who fulfilled the endocrine inclusion criteria (n = 40). The control group was a random sample (n = 40) from the cohort of women undergoing ART. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): To evaluate the sensitivity and specificity of different serum E(2) cut-off levels on day 11 of ovarian stimulation in preventing the establishment of OHSS. RESULT(S): Three hundred ninety-nine cycles (IVF and intracytoplasmic sperm injection) were undertaken between June 2000 and May 2001. The study group (n = 40) was compared with the control group (n = 40) undergoing ART during the same period of time. On day 8 of ovarian stimulation, the mean (SD) E(2) level in the study group was 8,517(5.3) pmol/L (2,320 pg/mL), and in the control group it was 2,540 (2.6) pmol/L (691 pg/mL). On day 11 of stimulation the mean (SD) E(2) level was 15,662 (4.2) pmol/L (4,266 pg/mL) and 5,804 (4.5) pmol/L (1,581 pg/mL), respectively. Twenty-four (60%) women who developed OHSS had E(2)levels >6,000 pmol/L (1,634 pg/mL) on day 8 and above 11,000 pmol/L (2,996 pg/mL) on day 11. Sixteen (40%) had E(2) levels <6,000 pmol/L (1,634 pg/mL) on day 8, but all had levels above 11,000 pmol/l (2,996 pg/mL) on day 11. CONCLUSION(S): A serum E(2) level of 12,315 pmol/L (3,354 pg/mL) on day 11 of ovarian stimulation gives a sensitivity and specificity of 85% for the detection of women at risk for OHSS.