Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery

Bivalve vaginal speculum insertion is a basic final step of vaginal examination. Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such cases, the value of vaginoscopy (examination of the vagina without speculum) is evident. Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the effectiveness and feasibility of using hysteroscopy for exploration of the immature genital tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as an easy way to gain access to the cervical canal and an important tool with which to diagnose and treat vaginal lesions.

In practice, we notice leakage of excessive irrigating fluid per vagina with poor visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution to improve visualization and success of vaginoscopic surgery. This study aims to test feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery in patients with vaginal or cervical lesions.

Study Overview

• Status: Completed
• Conditions: Endosalpingiosis
• Intervention / Treatment: Device: Tight vaginoscope

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 46 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Symptomatizing women with suspected narrow vagina.
• Nulliparous women or virgin w
• Vaginal or cervical lesion or foreign body.

Exclusion Criteria:

• Multiparous women
• Nulliparous women with patulous or lax vaginae were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tight vaginoscope; The vaginoscope was extracted and loaded inside a thick rubber ring before its reinsertion inside the vagina again. To avoid leakage from the center of the thick rubber ring, the vaginoscopy is inserted through a premade central cruciate incision.	Device: Tight vaginoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success rate of the procedure	20 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
The satisfaction rate by satisfaction score	20 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes