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Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools. Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs--three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no: RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_ date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction. Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1-4.6] compared with the spinal needle at 4.1 (90% CI: 3.5-4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device toadministerPCBforMVA.Noadverse eventswere noted. Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Visual tools are a valuable tool for ascertaining patient symptoms, especially in populations with low literacy rates. The objective was to develop and validate a pictorial scale for assessing symptomatic pelvic organ prolapse (POP) and urinary incontinence among women in western Kenya. Methods: Illustrations of POP, stress urinary incontinence (SUI), and urgency urinary incontinence (UUI) were developed by an artist. Virtual Zoom interviews were conducted with gynecology providers in Kisumu soliciting feedback on the illustrations. Cognitive interviews with patients were then conducted. Validation of the illustrations was performed against the gold standard of clinical history and examination amongst patients presenting for outpatient care at three Kisumu hospitals. Results: Sixteen provider interviews were conducted. The illustrations were revised to reflect each disorder more clearly, and performed well during cognitive interviews with 8 patients (aged 21 to 76). One hundred patients were included in the validation study. Nine patients had symptomatic POP, whereas 32 had UUI and 25 had SUI. Sensitivity and specificity for the SUI illustration was 80% (95% CI 61–91%) and 97% (95% CI 72–98%) and for UUI they were 81% (95% CI 65–91%) and 99% (95% CI 92–100%) respectively. POP illustrations had lower sensitivity and specificity, with the best performing illustration having sensitivity of 67% (95% CI 35–88%) and specificity of 99% (95% CI 94–100%), which improved when only bulge or pressure symptoms were included. Conclusions: We present a newly developed pictorial scale to assess for clinical urinary incontinence and POP that may be adapted and evaluated in other settings for clinical and research purposes. [ABSTRACT FROM AUTHOR]