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Relationship Between Bladder Distention and Hysteroscopy Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 10, 2013
First Posted Date  ICMJE May 8, 2013
Results First Submitted Date  ICMJE July 26, 2013
Results First Posted Date  ICMJE December 16, 2013
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE April 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
ease of cervical entry [ Time Frame: two months ]
Ease of cervical entry which will be assessed by Likert scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Patient Acceptability and Pain Scoring [ Time Frame: two months ]
    Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
  • Procedure Duration [ Time Frame: two months ]
    Procedural time which will be measured in minutes
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • Procedure Duration [ Time Frame: two months ]
    Procedural time which will be measured in minutes
  • Patient acceptability and pain scoring [ Time Frame: two months ]
    Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relationship Between Bladder Distention and Hysteroscopy Application
Official Title  ICMJE The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Menorrhagia
Intervention  ICMJE Procedure: Hysteroscopy
Study Arms  ICMJE
  • Experimental: Full Bladder
    Hysteroscopy conducted under full bladder.
    Intervention: Procedure: Hysteroscopy
  • Experimental: Empty Bladder
    Hysteroscopy conducted under empty bladder.
    Intervention: Procedure: Hysteroscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2013)
102
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
100
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 17 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848847
Other Study ID Numbers  ICMJE 9598
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party CEM CELIK, Namik Kemal University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Namik Kemal University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cem Celik, Assist Prof Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology
PRS Account Namik Kemal University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP