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Completed

NCT Number: NCT01848847

Relationship Between Bladder Distention and Hysteroscopy Application

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

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

17 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology

Tekirdağ, 59100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hysteroscopy

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 8, 2013
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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