NCT01848847

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 16, 2013

Completed
Last Updated

December 16, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

April 10, 2013

Results QC Date

July 26, 2013

Last Update Submit

October 28, 2013

Conditions

Menorrhagia

Keywords

HysteroscopyBladderPainFeasibilityDuration

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 months

  • 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

    2 months

Secondary Outcomes (2)

  • Patient Acceptability and Pain Scoring

    two months

  • Procedure Duration

    two months

Study Arms (2)

Full Bladder

EXPERIMENTAL

Hysteroscopy conducted under full bladder.

Procedure: Hysteroscopy

Empty Bladder

EXPERIMENTAL

Hysteroscopy conducted under empty bladder.

Procedure: Hysteroscopy

Interventions

HysteroscopyPROCEDURE
Empty BladderFull Bladder

Eligibility Criteria

Age17 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who are at reproductive age
  • Women who are not pregnant at the time of presentation
  • Women who are not nulliparous

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology

Tekirdağ, 59100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 18439502BACKGROUND

  • 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.

    PMID: 22387163BACKGROUND

  • 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.

    PMID: 10648742BACKGROUND

  • 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.

    PMID: 15200787BACKGROUND

MeSH Terms

Conditions

MenorrhagiaPain

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Limitations and Caveats

difficulties in introduction of hysteroscopy

Results Point of Contact

Title
cem celik
Organization
namik kemal university
cemcel@yahoo.com
905324205365

Study Officials

  • Cem Celik, Assist Prof

    Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2013

First Posted

May 8, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 16, 2013

Results First Posted

December 16, 2013

Record last verified: 2013-07

Locations

TU(1)