Back to resultsRelationship Between Bladder Distention and Hysteroscopy Application
Primary Purpose
Menorrhagia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hysteroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Menorrhagia focused on measuring Hysteroscopy, Bladder, Pain, Feasibility, Duration
Eligibility 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.
Sites / Locations
- Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Full Bladder
Empty Bladder
Arm Description
Hysteroscopy conducted under full bladder.
Hysteroscopy conducted under empty bladder.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Patient Acceptability and Pain Scoring
Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Procedure Duration
Procedural time which will be measured in minutes
Full Information
NCT ID
NCT01848847
First Posted
April 10, 2013
Last Updated
October 28, 2013
Sponsor
Namik Kemal University
1. Study Identification
Unique Protocol Identification Number
NCT01848847
Brief Title
Relationship Between Bladder Distention and Hysteroscopy Application
Official Title
The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Namik Kemal University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Hysteroscopy, Bladder, Pain, Feasibility, Duration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full Bladder
Arm Type
Experimental
Arm Description
Hysteroscopy conducted under full bladder.
Arm Title
Empty Bladder
Arm Type
Experimental
Arm Description
Hysteroscopy conducted under empty bladder.
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Primary Outcome Measure Information:
Title
Ease of Cervical Entry
Description
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
Title
Pain Scoring(VAS)
Description
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 Outcome Measure Information:
Title
Patient Acceptability and Pain Scoring
Description
Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Time Frame
two months
Title
Procedure Duration
Description
Procedural time which will be measured in minutes
Time Frame
two months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cem Celik, Assist Prof
Organizational Affiliation
Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology
City
Tekirdag
ZIP/Postal Code
59100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
18439502
Citation
Kabli N, Tulandi T. A randomized trial of outpatient hysteroscopy with and without intrauterine anesthesia. J Minim Invasive Gynecol. 2008 May-Jun;15(3):308-10. doi: 10.1016/j.jmig.2008.01.013. Epub 2008 Mar 20.
Results Reference
background
PubMed Identifier
22387163
Citation
Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
Results Reference
background
PubMed Identifier
10648742
Citation
De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
Results Reference
background
PubMed Identifier
15200787
Citation
Pansky M, Feingold M, Bahar R, Neeman O, Asiag O, Herman A, Sagiv R. Improved patient compliance using pediatric cystoscope during office hysteroscopy. J Am Assoc Gynecol Laparosc. 2004 May;11(2):262-4. doi: 10.1016/s1074-3804(05)60211-3.
Results Reference
background
Learn more about this trial
Relationship Between Bladder Distention and Hysteroscopy Application
We'll reach out to this number within 24 hrs