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Relationship Between Bladder Distention and Hysteroscopy Application

NCT ID: NCT01848847

Last Updated: 2013-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Menorrhagia

Keywords

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Hysteroscopy Bladder Pain Feasibility Duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Full Bladder

Hysteroscopy conducted under full bladder.

Group Type EXPERIMENTAL

Hysteroscopy

Intervention Type PROCEDURE

Empty Bladder

Hysteroscopy conducted under empty bladder.

Group Type EXPERIMENTAL

Hysteroscopy

Intervention Type PROCEDURE

Interventions

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Hysteroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Namik Kemal University

OTHER

Sponsor Role lead

Responsible Party

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CEM CELIK

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cem Celik, Assist Prof

Role: STUDY_DIRECTOR

Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology

Locations

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Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology

Tekirdağ, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18439502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22387163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10648742 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15200787 (View on PubMed)

Other Identifiers

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9598

Identifier Type: -

Identifier Source: org_study_id