Relationship Between Bladder Distention and Hysteroscopy Application

Not Applicable

Completed

• Conditions: Menorrhagia
• Interventions: Procedure: Hysteroscopy

• Registration Number: NCT01848847
• Lead Sponsor: Namik Kemal University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2013-07-26
• Results First Submitted QC: 2013-10-28
• Last Update Submitted: 2013-10-28
• Results First Posted: 2013-12-16
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Bladder	Hysteroscopy	Hysteroscopy conducted under full bladder.
Empty Bladder	Hysteroscopy	Hysteroscopy conducted under empty bladder.

Primary Outcome Measures

Name	Time	Method
Ease of Cervical Entry	2 months	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.
Pain Scoring(VAS)	2 months	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

Secondary Outcome Measures

Name	Time	Method
Patient Acceptability and Pain Scoring	two months	Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Procedure Duration	two months	Procedural time which will be measured in minutes

Trial Locations

Locations (1)

Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology; 🇹🇷 Tekirdag, Turkey