Relationship Between Bladder Distention and Hysteroscopy Application

Namik Kemal University102 enrolled

Overview

The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.

Women who should have diagnostic hysteroscopy procedure will be randomly allocated into two groups. In the first group hysteroscopy will be performed with a filled bladder and in the second group procedure will be performed with an empty bladder. The women will be assigned into groups randomly. The duration of the procedure, feasibility of the procedure and tolerability of procedure will be recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

102

Conditions

Menorrhagia

Interventions

HysteroscopyPROCEDURE

Eligibility

Sex: FEMALEMin age: 17 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women who are at reproductive age * Women who are not pregnant at the time of presentation * Women who are not nulliparous Exclusion Criteria: * Women who have previous cervical surgery or cervical incompetence. * Women who have genitourinary infection * Women who have profuse uterine bleeding or recent uterine perforation * Women who have neurological disorders affecting evaluation of pain.

Locations (1)

Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology

Tekirdağ, Turkey (Türkiye)

Outcomes

Primary Outcomes

Ease of Cervical Entry

Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.

Time frame: 2 months

Pain Scoring(VAS)

Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number

Time frame: 2 months

Secondary Outcomes

Patient Acceptability and Pain Scoring

Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.

Time frame: two months

Procedure Duration

Procedural time which will be measured in minutes

Time frame: two months

Data from ClinicalTrials.gov

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