Menorrhagia
Conditions
Keywords
Hysteroscopy, Bladder, Pain, Feasibility, Duration
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.
Interventions
PROCEDUREHysteroscopy
Sponsors
Namik Kemal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Cervical Entry | 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. |
| Pain Scoring(VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptability and Pain Scoring | two months | Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale. |
| Procedure Duration | two months | Procedural time which will be measured in minutes |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Empty Bladder Hysteroscopy conducted under empty bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy | 49 |
| Full Bladder Hysteroscopy conducted under full bladder.
Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy | 48 |
| Total | 97 |
Baseline characteristics
| Characteristic | Full Bladder | Empty Bladder | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 49 Participants | 97 Participants |
| Age Continuous | 41.07 years STANDARD_DEVIATION 7.68 | 39.51 years STANDARD_DEVIATION 7.04 | 40.27 years STANDARD_DEVIATION 7.36 |
| Region of Enrollment Turkey | 48 participants | 49 participants | 97 participants |
| Sex: Female, Male Female | 48 Participants | 49 Participants | 97 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 47 |
| serious Total, serious adverse events | 0 / 49 | 0 / 47 |
Outcome results
Primary
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.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empty Bladder | Ease of Cervical Entry | 4.00 units on a scale | Standard Deviation 0.86 |
| Full Bladder | Ease of Cervical Entry | 3.55 units on a scale | Standard Deviation 0.9 |
Primary
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
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empty Bladder | Pain Scoring(VAS) | 2.52 units on a scale | Standard Deviation 1.2 |
| Full Bladder | Pain Scoring(VAS) | 1.95 units on a scale | Standard Deviation 1.1 |
Secondary
Patient Acceptability and Pain Scoring
Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Time frame: two months
Secondary
Procedure Duration
Procedural time which will be measured in minutes
Time frame: two months