Relationship Between Bladder Distention and Hysteroscopy Application

Study Overview
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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.

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

Conditions
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Menorrhagia

Intervention / Treatment
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* Procedure: Hysteroscopy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Bladder<br>Hysteroscopy conducted under full bladder. | Procedure: Hysteroscopy<br> <br> |
| Experimental: Empty Bladder<br>Hysteroscopy conducted under empty bladder. | Procedure: Hysteroscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability and Pain Scoring | Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale. | two months | 
| Procedure Duration | Procedural time which will be measured in minutes | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, Bladder, Pain, Feasibility, Duration