A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system.

Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture. Preliminary bench testing for comparison of the Callascope camera to a $20,000 high-end colposcope demonstrated that the Callascope camera meets visual requirements for cervical imaging. Bench testing of the spray mechanism demonstrates that the contrast agent delivery enables satisfactory administration and cervix coverage. Clinical studies performed at Duke University Medical Center, Durham, USA and in Greater Accra Regional Hospital, Accra, Ghana assessed (1) the Callascope's ability to visualize the cervix compared to the standard-of-care speculum exam, (2) the feasibility and willingness of women to use the Callascope for self-exams, and (3) the feasibility and willingness of clinicians and their patients to use the Callascope for clinician-based examinations. Cervix visualization was comparable between the Callascope and speculum (83% or 44/53 women vs. 100%) when performed by a clinician. Visualization was achieved in 95% (21/22) of women who used the Callascope for self-imaging. Post-exam surveys indicated that participants preferred the Callascope to a speculum-based exam. Our results indicate the Callascope is a viable option for clinician-based and self-exam speculum-free cervical imaging.Clinical study registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT00900575, Pan African Clinical Trial Registry (PACTR) https://www.pactr.org/ PACTR201905806116817.

Examination of the pediatric adolescent patient.

Gynecologic examination of the pediatric adolescent patient provides a valuable opportunity for patient education and diagnosis, yet presents special challenges, including achieving comfort for the patient and guardian and finding equipment that are sized for pediatric patient. Anatomic changes due to the hormonal environment evolve from newborn through pubertal development. As pediatric adolescent gynecology has evolved as a specialty, techniques and training for providing optimal office and surgical examination have emerged. Where possible, the patient should be engaged with the examination through use of a mirror or positioning. Smaller swabs should be used for testing for vaginal infection in prepubertal patients. When speculum or office examination is not possible, use of narrow-caliber, flexible, and rigid hysteroscopes allow vaginoscopy for assessment.

A Classical Wooden Vaginal Speculum Mentioned in Old Medical Manuscripts.

The subject of this paper is the story of an ancient medical instrument. This instrument is a wooden vaginal speculum used in classical and Islamic medicine. Its drawings can be found in Abulcasis al-Zahrawi's and Serefeddin Sabuncuoglu's illustrated books of surgery.

Use of hysteroscope for vaginoscopy or hysteroscopy in adolescents for the diagnosis and therapeutic management of gynecologic disorders: a systematic review.

STUDY OBJECTIVE: The purpose of this article is to review the published literature and perform a systematic review to evaluate the effectiveness and feasibility of the use of a hysteroscope for vaginoscopy or hysteroscopy in diagnosing and establishing therapeutic management of adolescent patients with gynecologic problems. DESIGN: A systematic review. SETTING: PubMed, Web of science, and Scopus searches were performed for the period up to September 2013 to identify all the eligible studies. Additional relevant articles were identified using citations within these publications. PARTICIPANTS: Female adolescents aged 10 to 18 years. RESULTS: A total of 19 studies were included in the systematic review. We identified 19 case reports that described the application of a hysteroscope as treatment modality for some gynecologic conditions or diseases in adolescents. No original study was found matching the age of this specific population. CONCLUSIONS: A hysteroscope is a useful substitute for vaginoscopy or hysteroscopy for the exploration of the immature genital tract and may help in the diagnosis and treatment of gynecologic disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow vagina.

Does lubrication of the vaginal speculum reduce pain during a gynecologic oncology examination?

OBJECTIVE: To evaluate the effectiveness of lubricant gel for reducing pain during a vaginal speculum examination (SE) in patients with gynecologic cancers. STUDY DESIGN: This non blind randomized controlled trial included 200 women who underwent SE for post-treatment surveillance. One-hundred patients each were allocated to the water and lubricant gel groups. All patients were asked to score their pain during speculum insertion, dilatation, and extraction using a visual analog scale (VAS). Pain intensity during speculum insertion was the primary outcome measure. RESULTS: There were no statistically significant differences in demographic characteristics between the water (n = 97) and lubricant gel (n = 98) groups. The VAS pain scores obtained during all phases of the SE were significantly lower in the lubricant gel group compared with the water group during the insertion (3.95 ± 1.57 vs. 5.28 ± 1.71, P < 0.001), dilatation (5.96 ± 1.48 vs. 6.74 ± 1.69, P < 0.001) and extraction phases (2.60 ± 1.17 vs. 3.50 ± 1.25 P < 0.001). When a separate analysis was performed for the patients who underwent radiation therapy, the mean VAS pain scores were significantly lower in the lubricant gel group during the insertion (4.46 ± 1.45 vs. 6.22 ± 1.79, P < 0.001), dilatation (6.31 ± 1.66 vs. 7.52 ± 1.61, P = 0.002) and extraction phases (2.68 ± 1.31 vs. 3.66 ± 1.06, P = 0.001). CONCLUSION: The use of speculum lubricant gel significantly decreased pain during the SE in gynecologic oncology patients.

Sheathed versus standard speculum for visualization of the cervix.

OBJECTIVE: To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination. METHODS: We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice. Patients underwent examination via a standardized technique with either a medium-sized plastic speculum (standard) or an identical speculum modified with a flexible polypropylene sheath (sheathed). Investigators recorded the percentage of the cervix visualized. After speculum insertion, patients recorded pain using a 10-cm visual analog scale. RESULTS: There were no substantial demographic differences between the standard (n=67) and the sheathed (n=68) groups. Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum (95.1%±8.2% vs. 78.2%±18.4%; P<0.001), representing a 21.6% improvement in visualization, and were able to visualize the entire cervix in 42 (61.8%) patients when using the sheathed speculum compared with 11 (16.4%) patients undergoing standard speculum examination (P<0.001). Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores (1.0 vs 1.2; P=0.087). CONCLUSION: A sheathed speculum significantly improves visualization of the cervix, without compromising patient comfort. ClinicalTrials.gov:NCT01670630.

The value of expert review in prospective trials of automated assisted screening devices.

Previous prospective studies of automated assisted gynecologic screening devices have used a panel of experts for truth determination. We sought to determine the value of this practice. The relative sensitivity of the devices compared with manual screening was calculated using an expert panel for truth determination and compared using likelihood ratios to the relative sensitivity assuming all abnormal cases were truly abnormal. These results show that expert panel review has no significant effect on relative sensitivity at the threshold of ASCUS+ but may have an effect at HSIL+. Trials without expert consensus review may be compared to those with expert consensus review at the threshold of ASCUS+ but may not be reliable at the threshold of HSIL+ without additional confirmatory data.

Posterior vaginal wall pull down maneuver: a clinical test to diagnose intrinsic sphincter deficiency in women suffering from genuine urinary stress incontinence.

OBJECTIVES: To assess the predictive value of a simple clinical test (posterior vaginal wall pull down maneuver) in the diagnosis of intrinsic sphincter deficiency. METHODS: The present prospective study included 62 women suffering from stress urinary incontinence. Every patient underwent a urogynecological examination including multichannel urodynamic testing (cystometry, urethral pressure profile, Valsalva Leak Point Pressure measurement) and a clinical examination including posterior vaginal wall pull down maneuver. Posterior vaginal wall pull down maneuver was carried out with the bladder filled with 400 mL of saline in a supine position, and was obtained by means of a split speculum allowing gentle pull down traction of the posterior vaginal wall. Posterior vaginal wall pull down maneuver was considered as positive when a urine leak was observed during the manoeuvre. Intrinsic sphincter deficiency was urodynamically defined by maximum urethral closure pressure ≤20 cmH2 O. Correlations between positive/negative posterior vaginal wall pull down maneuver and urodynamic intrinsic sphincter deficiency were calculated. RESULTS: There was a statistical correlation between age and low maximum urethral closure pressure (P < 0.0001), and between low maximum urethral closure pressure and positive posterior vaginal wall pull down maneuver (P < 0.0001). Regarding the intrinsic sphincter deficiency diagnosis, the posterior vaginal wall pull down maneuver positive predictive value was 94.67% and the negative predictive value was 95.4%, with a specificity of 97.6% and sensitivity of 90%. CONCLUSION: Posterior vaginal wall pull down maneuver is a reliable clinical test, easy to carry out, inexpensive and without significant risk. This test allows the diagnosis of intrinsic sphincter deficiency in women suffering from stress urinary incontinence, thus avoiding further invasive urodynamic testing (urethral pressure profile, Valsalva Leak Point Pressure measurement) in women with genuine stress urinary incontinence. Furthermore, it is helpful when choosing the type of sling procedure (retropubic vs transobturator) when a surgery is planned.

'About as comfortable as a stranger putting their finger up your nose': speculation about the (extra)ordinary in gynaecological examinations.

In public health education, gynaecological examinations are presented as a routine and ordinary procedure. Medical research addressing women's reasons for screening reluctance emphasises underlying psychological categories of 'anxiety' and 'poor coping'. Minimal attention is paid to the effects of clinicians' interventions upon women's decision-making. Normalising promotes women's participation as speculum examinations are an essential part of many contemporary diagnostic and treatment procedures. In-depth email interviews were conducted with 26 women with diagnosis of either of the two commonest viral sexually transmitted infections, human papilloma virus and herpes simplex virus, and 12 sexual health clinicians. Data were analysed thematically. Findings indicate that women's screening compliance is influenced by clinicians' (in)attention to power relations, rapport-building, attentiveness to bodily (dis)comfort, technical skill and gender. Women's feedback is a valuable resource in devising interventions that may promote participation in examinations.

Can de novo stress incontinence after anterior wall repair be predicted?

OBJECTIVE: To locate preoperatively continent women with pelvic organ prolapse at risk of developing incontinence after surgery by means of reducing the prolapse preoperatively with a speculum and a pessary. DESIGN: Prospective observational cohort study. SETTING: Departments of Obstetrics and Gynecology at Northern Alvborgs County Hospital, Varbergs Hospital, and Sahlgrenska University Hospital, Sweden, between 2000 and 2004. POPULATION: Patients scheduled for anterior wall repair with no history of incontinence. METHODS: Data were collected using a questionnaire, a voiding diary, a gynecological examination including staging of prolapse with the Pelvic Organ Quantification System and clinical testing preoperatively and one year after vaginal repair. The first test included a cough test while the prolapse was reduced with a speculum. The second test was performed with the patient undergoing a standardized quantification test and a 48-hour pad test after reducing the prolapse with a pessary. Postoperatively, clinical testing was repeated one year after surgery without any device in place. MAIN OUTCOME MEASURES: Reported symptoms of leakage during movement or coughing. RESULTS: Seventy-four patients were included. Before surgery, six (8.1%) women tested positive during the speculum test and seven (9.5%) during the pessary test. Eight women (10.8%) were found to have subjective urinary stress incontinence after 1 year. This was only confirmed in four women during stress testing. The positive predictive values for subjective stress incontinence of the speculum and the pessary tests were 42.9% (95%CI 12.0-76.9) and 33.3% (95%CI -4.4 to +71.5), respectively. The negative predictive values of the tests were 92.5% (95%CI 90.3-1.00) and 91.1% (95%CI 88.5-99.7). CONCLUSIONS: The tested preoperative methods predicting de novo subjective stress incontinence after anterior wall repair did not show sufficient positive predictive values to be clinically useful.