Transrectal and 3D Transabdominal Ultrasound Compared to Vaginoscopy in Diagnosing Virgins With Genital Lesions
Condition: Virginity; Genital Diseases, Female; Diagnoses Disease
MeSH terms: Genital Diseases; Genital Diseases, Female
Study type: Interventional

Summary: 
      This study is to compare the feasibility and test performance of different 3D pelvic
      ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus ,
      cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden
      standard modality of diagnosis in Virgin Patients
    

Detailed description: 
      Virginity is a very private issue; saving or losing it is a matter of choice depending on
      age, ethnicity, religion, or simply personal decision. Post-pubertal teenage girls, religious
      women such as nuns, and women in some countries tend to be virgin. This situation must be
      respected by medical professionals. But when a vaginal examination is necessary, virginity
      might be a limiting factor for the gynecologist in diagnosis and treatment.

      Vaginal discharge or bleeding is the symptom most commonly reported by adolescent girls that
      are referred for gynecologic problems. The most common cause of vaginal discharge at these
      ages is infection due to a hypo-estrogenized vagina, although other potential causes, such as
      congenital anomalies of the genitalia, trauma, foreign bodies, sexual abuse, and malignant
      disease, must also be excluded. With regard to virginity and childbearing possibility in the
      future, a careful approach is of paramount importance.

      Hymenal tissue does not easily tolerate vigorous manipulation and wide movements. When
      needed, potential hymeneal disruption may be discussed with mature women or with the parents
      of adolescent girls for the sake of correct diagnosis and treatment; but in general, they are
      highly resistant to that.

      When a reproductive tract examination or transvaginal operation must be arranged for a
      virgin, the operator faces a challenge and may hesitate to utilize hysteroscopy, which can
      result in a delayed diagnosis or improper treatment.

      The most common indication for hysteroscopy is abnormal vaginal bleeding in virginal patients
      and has been widely used for uterine cavity examination and management. Although the
      possibility of hymen preservation is high, virgins are highly resistant to this procedure.
      This may be due to a belief that the procedure causes disruption of virginity and worries
      associated with their future partners.

      The approach by vaginoscopy and hysteroscopy via a hysteroscope provides a safe and
      non-traumatic method in assessing the reproductive organs because the scope of the
      hysteroscope is advanced into the vagina without a speculum or tenaculum. Distension of the
      vaginal wall by distension medium can in turn provide a clear endoscopic view.

      These considerations have made clinicians opt for these procedures in assessing pathologies
      of the vagina, the surface of the cervix, the cervical canal, and the intrauterine cavity and
      other developmental anomalies of the sex organs in patients. Furthermore, the entire
      procedure can be undertaken without disrupting integrity of the hymen, whereas the
      traditional method requires the use of retractors and, therefore, disrupts this integrity.

      Although hysteroscopy can improve diagnosis and thereby improve quality of life, virgins may
      decline this procedure. Patients with delayed diagnosis and management in some uncommon but
      serious situations, such as endometrial malignancy, are life-threatening.

      So far, only a few reports have discussed the protection of hymen integrity in hysteroscopy,
      and the physical and psychological impacts of this surgery in virgins are not conclusive
      .This is an important issue that gynecologists encounter, but which has seldom been
      discussed. Intravenous sedation is recommended to reduce the patient's anxiety and pain,
      avoid vasovagal reaction, relax the buttock muscles and reduce the risk of hymenal trauma .
      Unlike operative hysteroscope, loop electrode cannot be employed in mini-hysteroscope;
      therefore, for some diseases like submucous leiomyoma or uterine septum, mini-hysteroscopy is
      not therapeutically beneficial, and this should be explained to the patients in advance.
      Adequate preoperative counseling is also necessary to emphasize the importance of the
      procedure and to lessen their anxiety.

      In virgin patients when vaginal examination cannot be done ultrasonography is a useful
      adjunct to inspection of the external genital organs.

      Currently there are three accepted and more or less widely used modalities to image the
      contents of the female pelvis. Transabdominal sonography (TAS) was the first to be used and
      is still the most widespread.

      By using a full urinary bladder as an acoustic window, ovaries, uterus, and superior vagina
      can be clearly examined using transabdominal (TA) ultrasonography.

      Transvaginal sonography provides clear images of the region of interest, provided that the
      targeted organ is within the focal range of the probe, and that the probe is placed in
      proximity to the organ in question .

      Agenesis of the vagina, a virginal introitus and the fear of introducing infection such as in
      the case of premature rupture of the membranes are some of the more common situations in
      which Transvaginal ultrasound is not possible or is relatively contraindicated.

      In such cases introducing a commercially available vaginal probe through the anal sphincter
      into the rectum seems to be a reasonable alternative to image the female pelvic structures
      within 'reach' of the probe. We present a study to compare TAS and transrectal sonography
      (TRS) in a group of patients in whom Transvaginal ultrasound was not possible.

      Transrectal sonography (TRUS) has been widely used in men as a diagnostic tool for prostate
      cancer. Its value in the management of disorders of the lower urinary tract in women and as
      an alternative to intraoperative gynecologic sonography has also been documented . Case
      reports in the radiological literature attest to the fact that it has been used to guide
      drainage of inflammatory pelvic collections.
    

Intervention name(s): 3D transabdominal ultrasound; transrectal ultrasound; vaginoscopy
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Initially 3D pelvic ultrasound will be performed on all patients. The transabdominal probes used will be those of the ultrasound scanner using a convex probe (multiple frequency 1-6 MHz).; The vaginal probe will be covered with the customary plastic sheath and richly lubricated with lubricating gel. The probe will then be slowly advanced into the rectum. The transvaginal probes used will be those of the ultrasound scanner using a vaginal probe (multiple frequency 1-8 MHz). The scanning technique will be similar to that of Transvaginal ultrasound.; It is the final procedure in the study to reach the accurate diagnosis. A rigid hysteroscope will be used. The sheath has a 5-mm outer diameter, with 2.9 mm rod lens. A high intensity light source and fiberoptic cable will be used to illuminate the uterine cavity. A solution of 0.9% normal saline will be used as the distention medium. The pressure will be kept at 100-120 mmHg using a pressure adjustable cuff system with the aim of maintaining the lowest pressure required to distend the uterine cavity.
Intervention model: Single Group Assignment
Intervention model description: A diagnostic test accuracy study that will be conducted at Ain-Shams University Maternity Hospital ,the patients will be recruited from women admitted from gynecologic clinic or from emergency room and from patients following up in outpatient clinic patients will be recruited to this study All Patients recruited must have suspected uterine, cervical or vaginal lesion by history, examination and Pelvic ultrasound
Masking: None (Open Label)
Primary purpose: Diagnostic