Relationship Between Bladder Distention and Hysteroscopy Application

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848847
• Other study ID #: 9598
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: October 28, 2013
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Namik Kemal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Menorrhagia
• Urinary Retention

Intervention

Procedure:
• Hysteroscopy

Locations

Country	Name	City	State
Turkey	Namik Kemal University Faculty of Medicine Department of Obstetric and Gynecology	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 months	No
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	2 months	Yes
Secondary	Patient Acceptability and Pain Scoring	Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.	two months	No
Secondary	Procedure Duration	Procedural time which will be measured in minutes	two months	No