Relationship Between Bladder Distention and Hysteroscopy Application

• Sponsor: Namik Kemal University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01848847
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 34.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Procedure: Hysteroscopy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Full Bladder Hysteroscopy conducted under full bladder.	Procedure: Hysteroscopy
Experimental: Empty Bladder Hysteroscopy conducted under empty bladder.	Procedure: Hysteroscopy

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Patient Acceptability and Pain Scoring [two months]

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

2. Procedure Duration [two months]

   Procedural time which will be measured in minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology	Tekirdag		Turkey	59100

Sponsors and Collaborators

• Namik Kemal University

Investigators

• Study Director: Cem Celik, Assist Prof, Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: CEM CELIK, Assistant Professor, Namik Kemal University
• ClinicalTrials.gov Identifier: NCT01848847
• Other Study ID Numbers: 9598
• First Posted: May 8, 2013
• Last Update Posted: Dec 16, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by CEM CELIK, Assistant Professor, Namik Kemal University: Hysteroscopy; Bladder; Pain; Feasibility; Duration
• Additional relevant MeSH terms: Menorrhagia; Urinary Retention

Study Results

Participant Flow

Arm/Group Title	Empty Bladder	Full Bladder
Arm/Group Description	Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
Period Title: Overall Study
STARTED	51	51
COMPLETED	49	48
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Empty Bladder	Full Bladder	Total
Arm/Group Description	Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Total of all reporting groups
Overall Participants	49	48	97
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 100%	48 100%	97 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.51 (7.04)	41.07 (7.68)	40.27 (7.36)
Sex: Female, Male (Count of Participants)
Female	49 100%	48 100%	97 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Turkey	49 100%	48 100%	97 100%

Outcome Measures

1. Primary Outcome

Title	Ease of Cervical Entry
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Empty Bladder	Full Bladder
Arm/Group Description	Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
Measure Participants	49	48
Mean (Standard Deviation) [units on a scale]	4.00 (0.86)	3.55 (0.90)

2. Secondary Outcome

Title	Patient Acceptability and Pain Scoring
Description	Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Time Frame	two months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Procedure Duration
Description	Procedural time which will be measured in minutes
Time Frame	two months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Primary Outcome

Title	Pain Scoring(VAS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Empty Bladder	Full Bladder
Arm/Group Description	Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy	Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
Measure Participants	49	48
Mean (Standard Deviation) [units on a scale]	2.52 (1.2)	1.95 (1.1)

Adverse Events

Arm/Group Title	Empty Bladder		Full Bladder
Arm/Group Description	Hysteroscopy conducted under empty bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy		Hysteroscopy conducted under full bladder. Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy
All Cause Mortality
	Empty Bladder		Full Bladder
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Empty Bladder		Full Bladder
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Empty Bladder		Full Bladder
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/47 (0%)

Limitations/Caveats

difficulties in introduction of hysteroscopy

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.