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VirginityNCT04858919

Transrectal and 3D Transabdominal Ultrasound Compared to Vaginoscopy in Diagnosing Virgins With Genital Lesions

A study testing 3D transabdominal ultrasound, transrectal ultrasound and vaginoscopy in people with Virginity and Genital Diseases, Female, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 5 to 55 years, women only
What is being tested?
3D transabdominal ultrasound, transrectal ultrasound and vaginoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Jun 2019to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 55 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Virgins complaining of Abnormal vaginal bleeding, abnormal discharge , pelvic pain
  • Virgins with Suspected genital tract lesion by examination
  • Virgins with Suspected genital tract lesion by pelvic ultrasound

Who cannot join

  • Sexually Active Patients
  • Suspected or documented Pregnancy
  • Virgin patients with no suspected uterine, cervical or vaginal lesion by pelvic ultrasound
  • Patients unable to communicate effectively

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams university faculty of medicine

    Cairo, 11591

Other trials in Egypt

About this study

Official title: Transrectal Ultrasound and 3D Transabdominal Ultrasound in Comparison to Vaginoscopy in Virgins With Suspected Genital Tract Lesions

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

Read the 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.

Being tested
3D transabdominal ultrasound, transrectal ultrasound, vaginoscopy
Medical subject headings
Sexual Abstinence, Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D transabdominal ultrasoundDiagnostic test

    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).

  • transrectal ultrasoundDiagnostic test

    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.

  • vaginoscopyDiagnostic test

    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.

Study groups in NCT04858919
Study groupRoleWhat they receive
study groupOthervirgins with genital tract lesion
Receives: Diagnostic Test: 3D transabdominal ultrasound; Diagnostic Test: transrectal ultrasound; Diagnostic Test: vaginoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of different diagnostic modalities in Virgins.

    By questionnaire to asses the acceptance of patient to undergo different modalities as 3D pelvic ultrasound, Transrectal ultrasound and vaginoscopy is assessed.

    Measured: 1 to 2 hours

  2. Test performance of different diagnostic modalities in Virgins

    diagnostic accuracy of 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 Virgins.

    Measured: 24 hours to 1 week

Secondary outcomes (2)
  1. Patients' satisfaction

    Visual Analogue Scale will be used for grading levels of patients' overall satisfaction by giving a range of potential scores (0-10) with a score 0 reflecting greatest satisfaction

    Measured: 1-2 hours

  2. patients' pain

    Visual Analogue Scale will be used for grading levels of patients' pain by giving a range of potential scores (0-10) with a score 0 reflecting least discomfort

    Measured: 1-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start1 Jun 2019
  3. Primary completion1 Mar 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04858919
Sponsor's protocol ID
vaginoscope
Status last verified
Apr 2021
First submitted
13 Apr 2021
Last updated
26 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 3D transabdominal ultrasound, transrectal ultrasound and vaginoscopy in people with Virginity and Genital Diseases, Female, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of different diagnostic modalities in Virgins. (time frame: 1 to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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