Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04858919 |
| Other study ID # |
vaginoscope |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
