Female Sexual Functioning in Women With a Symptomatic Pelvic Organ Prolapse; A Multicenter Prospective Comparative Study Between Pessary and Surgery.

BACKGROUND: Female pelvic organ prolapse (POP) has a negative effect on female sexual functioning and with an increasing life expectancy female sexual dysfunction caused by POP will be an arising global issue. AIM: Improvement in female sexual functioning, measured with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR), 24-months after pessary or surgery, for both sexually active (SA) and sexually inactive women (NSA) presenting with POP. METHODS: A multicenter prospective comparative cohort study was conducted in 22 Dutch hospitals. Women referred with moderate to severe POP symptoms and POP stage ≥ 2 were included and chose either pessary therapy or surgical intervention. The PISQ-IR was filled in at baseline and 24-months, the delta of change was calculated and compared between both groups. Multivariate linear regression was performed to adjust for potential confounding factors in the association between the summary score of the PISQ-IR and therapy. OUTCOMES: Change in PISQ-IR between pessary and surgical intervention. RESULTS: The delta of change at 24-months was calculated for 198 women in the pessary group and 129 women in the surgery group. SA women in the surgery group reported statistically significant more improvement on the condition-specific (-0.19 95%CI -0.35; -0.03, P = .02), and condition-impact (-0.48 95%CI -0.69; -0.28, P < .001) domains as well as on the summary score (-0.15 95%CI -0.23; -0.08, P < .001) as compared to the pessary group. No significant differences between pessary and surgery were found on the domains for NSA women. After controlling for potential baseline confounders, surgery still had a statistically significant effect on the summary score (B = 0.08; 95%CI interval 0.007-0.15, P = .03). Women having surgery had 2.62 times higher odds of changing from NSA to SA than pessary therapy. CLINICAL IMPLICATIONS: SA women who clearly express that POP-related symptoms limit their sexual functioning should be counseled that surgery results in a more remarkable improvement. STRENGTHS & LIMITATIONS: Our strengths include the large sample size, long-term follow-up, the use of the PISQ-IR as a validated outcome tool evaluating both SA and NSA women, and this study reflects real-life clinical practice that enhances the external validity of the findings. A limitation of our study is the considerable proportion of non-responders at 24-months follow-up. CONCLUSION: Sexual function in SA women with POP is superior in case surgery is performed as compared to pessary therapy. van der Vaart LR, Vollebregt A, Pruijssers B, et al. Female Sexual Functioning in Women With a Symptomatic Pelvic Organ Prolapse; A Multicenter Prospective Comparative Study Between Pessary and Surgery. J Sex Med 2022;19:270-279.

Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire - IUGA Revised (PISQ-IR).

BACKGROUND: To put statistically significant changes in patient reported outcome measurement (PROM) questionnaires into a clinical perspective, the concept of the minimal clinically important difference (MCID) can be used. AIM: To determine the MCID for the summary score for sexually active (SA) women of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), a validated instrument which assesses sexual functioning (SF) for patients suffering from a symptomatic pelvic floor disorder. METHODS: Patients participating in a multicentre prospective cohort study comparing pessary therapy with surgery for a symptomatic pelvic organ prolapse (POP) filled in the PISQ-IR at baseline and 12 months' follow-up. We used both an anchor-based as well as a distribution-based method to calculate the MCID for both treatment groups. The Patient Global Impression of Improvement (PGI-I) questionnaire and PISQ-IR question 19a about satisfaction with sexual functioning were used as anchors. For the distribution-based approach we used the effect size (ES). OUTCOMES: MCID for the SA summary score of the PISQ-IR. RESULTS: Data of 243 women were used to calculate the MCID. In the pessary group, Kendall's tau-b correlation coefficients between the PISQ-IR summary score and both anchors were below the cut-off of 0.21, which implies the anchors cannot be used to calculate an MCID. In our surgery group, the PISQ-IR question 19a met the anchor criteria and 0.31 points increase in the PISQ-IR summary score was equal to an improvement of 1 point on question 19a about satisfaction with sexual functioning. CLINICAL IMPLICATIONS: Future research on this subject should focus on clinical relevance of results rather than statistical significance only. STRENGTHS & LIMITATIONS: Our main strength is the fact that we used both anchor-based and distribution-based methods to determine our MCID. Secondly, we set out to determine an MCID for both treatment groups separately, which relatively enhances the generalisability of our results. A limitation is that we were not able to estimate an MCID for the pessary group. Pruijssers B, van der Vaart L, Milani F, et al. Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire - IUGA Revised (PISQ-IR). J Sex Med 2021;18:1265-1270. CONCLUSION: We estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group.

Delayed cord clamping vs cord milking in elective cesarean delivery at term: a randomized controlled trial.

BACKGROUND: Delayed cord clamping has significant beneficial effects on the neonate and its transition to extrauterine life and, therefore, is common practice at vaginal births in the Netherlands. In 2015, 16% of neonates were born via cesarean delivery; moreover, in 81% of these cases, the umbilical cord was clamped and cut immediately. Neonatal benefits of delayed cord clamping are an increased circulating volume of 25 to 30 mL/kg, leading to a higher preload of both the right and left ventricles during the transition from umbilical circulation to pulmonary circulation, thus maintaining a stable left ventricle output, and to higher neonatal hemoglobin and hematocrit levels 24 to 48 hours after birth. Currently, little is known about whether the abovementioned neonatal benefits of delayed cord clamping could apply to neonates delivered by cesarean delivery. In these cases, possible negative effects on neonatal outcomes (ie, neonatal hypothermia, lower Apgar scores, and hyperbilirubinemia) and maternal outcomes (ie, increased maternal blood loss and higher postoperative infection rate) should also be taken into consideration. OBJECTIVE: This study aimed to determine whether clamping the umbilical cord after 2 minutes is superior to cord milking during elective cesarean deliveries at term, taking both short- and long-term neonatal and maternal outcomes into consideration, and to determine whether cord milking could be an appropriate alternative to delayed cord clamping. STUDY DESIGN: A randomized controlled trial was conducted in a large secondary care center in the Netherlands (Amphia Hospital in Breda) from October 2020 to April 2022. A total of 115 patients who underwent an elective cesarean delivery between 37 0/7 and 41 6/7 weeks of gestation were included. The primary outcomes were neonatal hemoglobin and hematocrit levels at 48 hours after birth. The secondary outcomes were divided into neonatal and maternal outcomes. RESULTS: After randomization, 58 participants were treated with cord milking, and 57 participants were treated with delayed cord clamping. There was no significant difference in demographic characteristics between both groups. There was no significant difference in the primary outcomes, with a mean hemoglobin level 48 hours after birth of 12.1 mmol/L in the delayed cord clamping group and 12.2 mmol/L in the cord milking group (P=.80). Regarding our secondary outcomes, there was no significant difference regarding Apgar score, neonatal body temperature, maternal blood loss, and postoperative infection rate between our intervention groups. CONCLUSION: Hemoglobin and hematocrit levels at 48 hours after birth showed no significant difference when comparing delayed cord clamping with cord milking. Delayed cord clamping did not lead to increased maternal blood loss or postoperative infections compared with a method with a much shorter timeframe between delivery and clamping of the umbilical cord, namely, cord milking. In addition, delayed cord clamping did not lead to a lower Apgar score or neonatal temperature compared with cord milking. Our research suggests that delayed cord clamping can be safely performed during elective cesarean deliveries at term. If intraoperative circumstances do not allow for delayed cord clamping, cord milking can be an appropriate alternative for the neonate at term.