Relationship Between Bladder Distention and Hysteroscopy Application

October 28, 2013 updated by: CEM CELIK, Namik Kemal University

The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tekirdag, Turkey, 59100
        • Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full Bladder
Hysteroscopy conducted under full bladder.
Procedure: Hysteroscopy
Experimental: Empty Bladder
Hysteroscopy conducted under empty bladder.
Procedure: Hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Cervical Entry
Time Frame: 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.
2 months
Pain Scoring(VAS)
Time Frame: 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
2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Investigators

  • Study Director: Cem Celik, Assist Prof, Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9598

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menorrhagia

Clinical Trials on Hysteroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe