Trial Outcomes & Findings for Relationship Between Bladder Distention and Hysteroscopy Application (NCT NCT01848847)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

2 months

Results posted on

2013-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Empty Bladder Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Full Bladder Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
Overall Study STARTED	51	51
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relationship Between Bladder Distention and Hysteroscopy Application

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empty Bladder n=49 Participants Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Full Bladder n=48 Participants Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	39.51 years STANDARD_DEVIATION 7.04 • n=5 Participants	41.07 years STANDARD_DEVIATION 7.68 • n=7 Participants	40.27 years STANDARD_DEVIATION 7.36 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Turkey	49 participants n=5 Participants	48 participants n=7 Participants	97 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Empty Bladder n=49 Participants Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Full Bladder n=48 Participants Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
Ease of Cervical Entry	4.00 units on a scale Standard Deviation 0.86	3.55 units on a scale Standard Deviation 0.90

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Empty Bladder n=49 Participants Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Full Bladder n=48 Participants Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
Pain Scoring(VAS)	2.52 units on a scale Standard Deviation 1.2	1.95 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: two months

Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two months

Procedural time which will be measured in minutes

Outcome measures

Outcome data not reported

Adverse Events

Empty Bladder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Full Bladder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

cem celik

namik kemal university

Phone: 905324205365

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place