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.

A fiber-optic sensor-based device for the measurement of vaginal integrity in women.

AIMS: Pelvic floor disorders (PFDs) in women are a major public health concern. Current clinical methods for assessing PFDs are either subjective or confounded by interference from intra-abdominal pressure (IAP). This study introduces an intravaginal probe that can determine distributed vaginal pressure during voluntary exercises and measures the degree of vaginal tissue support independent of IAP fluctuations. METHODS: An intravaginal probe was fabricated with 18 independent fiber-optic pressure transducers positioned along its upper and lower blades. Continuous pressure measurement along the anterior and posterior vaginal walls during the automated expansion of the probe enabled the resistance of the tissue to be evaluated as a function of displacement, in a manner reflecting the elastic modulus of the tissue. After validation in a simulated vaginal phantom, in vivo measurements were conducted in the relaxed state and during a series of voluntary exercises to gauge the utility of the device in women. RESULTS: The probe reliably detected variations in the composition of sub-surface material in the vaginal phantom. During in-vivo measurements the probe detected distributed tissue elasticity in the absence of IAP change. In addition, the distribution of pressure along both anterior and posterior vaginal walls during cough, Valsalva and pelvic floor contraction was clearly resolved with a large variation observed between subjects. CONCLUSIONS: Our data highlight the potential for the probe to assess the integrity of the vagina wall and support structures as an integrated functional unit. Further in vivo trials are needed to correlate data with clinical findings to assist in the assessment of PFDs.

Optimised gynaecological examination with a new pelvic examination chair.

OBJECTIVE: The present aim was to contribute to improving the traditional pelvic examination chair with vertical leg support and to evaluate patients' and examiners' experience of a new gyneacological and urological examination chair with heated upholstery. STUDY DESIGN: A new gynaecological and urological examination chair was constructed with laterally adjustable leg support, a foot-plate and the perineum exposed only during the examination procedure. Patients (n = 131) with or without endometriosis were invited to participate in an anonymous questionnaire survey concerning how they experienced a gynaecological examination. MAIN OUTCOME MEASURES: The patients and the gynaecologists who performed the examinations answered questionnaires evaluating the examination procedure in the traditional and in the new gynaecological and urological examination chair, respectively. The questionnaires asked about comfort, heating, integrity and the experience of pelvic examination with vertical or lateral leg support. The examination times were measured with a stop-watch. RESULTS: The majority of the answers (n = 131) were significantly (p < 0.05-0.001) in favour of the new concept with lateral leg support and with increased comfort and integrity. The average examination time was significantly shortened and the patients more relaxed in the new gynaecological and urological examination chair. CONCLUSION: The traditional gynaecological chair with vertical leg support has remained basically unchanged for many years. The present study showed that the pelvic examination procedure can be significantly optimized with easy patient-friendly adaptations.

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.

Is intrapartum translabial ultrasound examination painless?

OBJECTIVES: To find out whether intrapartum translabial ultrasound examination is painless by comparing pain score of ultrasound-based versus digital vaginal examination of foetal head station. METHODS: In 94 women carrying uncomplicated-term singleton pregnancies, labour progress was assessed by translabial ultrasound, followed immediately by conventional digital vaginal examination. Pain scores (0-10) using visual analogue pain scale were obtained for both examinations. Forty-eight and forty-six sets of data were obtained in first and second stage of labour, respectively. The difference in pain scores between digital vaginal examination and translabial ultrasound was analysed. RESULTS: The median pain score for translabial ultrasound was 0 (range 0-8), while that for vaginal examination was 4.5 (range 0-10), p < 0.05. There was no significant difference in pain scores between first and second stages of labour for translabial ultrasound (p = 0.123) and for vaginal examination (p = 0.680). The pain score for vaginal examination was higher than that of translabial ultrasound in 81.9%, similar in 13.8% and lower in 4.3% of cases. There was no statistically significant difference in pain scores obtained for digital vaginal examination by clinicians with different experience (p = 0.941). CONCLUSIONS: Intrapartum translabial ultrasound is generally better tolerated than digital vaginal examination for assessment of labour progress, making it an acceptable adjunctive assessment tool during labour.

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.

State of the art review: Intravaginal probes for recording electromyography from the pelvic floor muscles.

AIM: To survey commercially available intravaginal probes designed to record electromyography (EMG) from the pelvic floor muscles (PFMs), and to discuss the strengths and limitations of current technology. METHODS: The MEDLINE EMBASE, CINAHL, PEDRO, and Cochrane databases were searched for articles in which intravaginal probes were described as having been used to record EMG from the PFMs. The World Wide Web was also searched using the Google search engine to find devices used to record EMG from the PFMs. Finally, a Canadian distributer of intravaginal probes was contacted to identify intravaginal EMG probes not identified through other methods. The specifications of each probe were determined through the manufacturer or their website, and each device was acquired by the investigators to verify the specifications and electrode configuration. The devices were evaluated against international standards for recording EMG data. RESULTS: Sixteen different models of commercially available intravaginal probes were identified: seven from published research papers, seven using the World Wide Web, and two through communication with a distributer. The probes vary in shape, dimensions, electrode positioning, and electrode configuration, with many designs prone to recording motion artifact, crosstalk, and/or inappropriate EMG signals. CONCLUSION: All commercially available intravaginal probes had deficiencies in their design such as problems with probe geometry, electrode size, location, and/or configuration. Improved intravaginal EMG probes should be developed for use in research and clinical practice.

Modification of the pelvic examination simulator for the developing world.

The clinical pelvic exam is a critical examination for external and internal inspection of female reproductive organs. A sensor enabled pelvic examination simulator was developed to provide immediate visual performance feedback. The simulator was modified for rural area usage, where electricity supply and PC display may not be available. We succeeded at replacing key components while maintaining functionality.

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.

Alternate light sources in sexual assault examinations: an evidence-based practice project.

The ability of sexual assault nurse examiners to correctly identify and collect DNA evidence improves patient outcomes and prosecution rates. The purpose of this paper is to present findings from a collaborative evidence-based practice (EBP) project between forensic nurses and baccalaureate nursing students. The goal of the project was to determine best practice using an alternate light source (ALS) to identify trace DNA evidence in sexual assault forensic examinations. Using the Johns Hopkins Nursing Evidence-based Practice model, the team searched several databases to summarize the limited amount of evidence available regarding this topic. Recommendations from the EBP project include: elimination of the Wood's lamp in sexual assault examinations; use of an ALS that provides appropriate wavelengths to detect DNA; education of forensic nurses about the advantages and limitations of an ALS; and additional research related to use of an ALS. By participating in similar collaborative efforts, practicing forensic nurses have the opportunity to collaborate with local colleges and universities to make complex projects more manageable while fulfilling the International Association of Forensic Nurses vision for ethical practice.

'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.