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Relationship Between Bladder Distention and Hysteroscopy Application

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ClinicalTrials.gov Identifier: NCT01848847
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
CEM CELIK, Namik Kemal University

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

Condition or disease Intervention/treatment Phase
Menorrhagia Procedure: Hysteroscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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



Primary Outcome Measures :
  1. 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. 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


Secondary Outcome Measures :
  1. Patient Acceptability and Pain Scoring [ Time Frame: two months ]
    Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.

  2. Procedure Duration [ Time Frame: two months ]
    Procedural time which will be measured in minutes



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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848847


Locations
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Turkey
Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology
Tekirdag, Turkey, 59100
Sponsors and Collaborators
Namik Kemal University
Investigators
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Study Director: Cem Celik, Assist Prof Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology

Publications:
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Responsible Party: CEM CELIK, Assistant Professor, Namik Kemal University
ClinicalTrials.gov Identifier: NCT01848847     History of Changes
Other Study ID Numbers: 9598
First Posted: May 8, 2013    Key Record Dates
Results First Posted: December 16, 2013
Last Update Posted: December 16, 2013
Last Verified: July 2013

Keywords provided by CEM CELIK, Namik Kemal University:
Hysteroscopy
Bladder
Pain
Feasibility
Duration

Additional relevant MeSH terms:
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Menorrhagia
Urinary Retention
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Menstruation Disturbances
Urination Disorders
Urologic Diseases