Comparison of Two Hysteroscopy Approaches

Menorrhagia Clinical Trial

Official title:

A New Approach to Office Hysteroscopy Compared With Traditional Hysteroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319410
• Other study ID #: EWMCgyn-1
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2006
• Last updated: November 27, 2006
• Start date: July 2005
• Est. completion date: December 2005

Study information

• Verified date: April 2006
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial compares two methods of diagnostic hysteroscopy: vaginoscopic hysteroscopy vs. traditional method. Pain intensity was estimated using a visual analogue scale (VAS), and patient satisfaction was evaluated. These endpoints were compared by treatment assignment. Vaginoscopic hysteroscopy was associated with significantly lower VAS scores, indicating reduced experience of pain in this treatment group; however, this was not associated with improved patient satisfaction.

Description:

OBJECTIVE: To compare the vaginoscopic approach of diagnostic hysteroscopy without anesthesia with the traditional diagnostic hysteroscopy after intracervical injection of Mepivacaine Hydrochloride 3%.

METHODS: A total of 130 women undergoing diagnostic hysteroscopy were included in the study and were randomized, using a computer-generated randomization list, into two groups with a ratio of 2:1. Eighty three women underwent vaginoscopy without speculum, tenaculum or anesthesia. Forty seven women received intracervical anesthesia with 10 ml of 3% mepivacaine hydrochloride solution injected at two sites (3:00 and 9:00 positions) and underwent traditional hysteroscopy using a speculum and tenaculum. Hysteroscopy was performed using a rigid 3.7 mm hysteroscope in a medium of 0.9% saline, and the image was transmitted to a screen visible to the patient. A Visual Scale Analogue (VAS) consisting of a 10 cm line was used to assess the intensity of pain experienced during and after the procedure. Overall patient satisfaction was assessed during, immediately after, 15 minutes later, and three days post hysteroscopy.

RESULTS: The mean pain score was significantly lower in the vaginoscopy group (3.8±2.7 vs 5.34±3.23, p=0.01). Patient satisfaction rate was similar in both groups.

CONCLUSION: Patients reported significantly less pain with the vaginoscopic approach to diagnostic hysteroscopy even without anesthesia compared to patients undergoing the traditional procedure with anesthesia. This new approach should therefore be considered as a replacement for the traditional hysteroscopic technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:adult female, referred for outpatient diagnostic hysteroscopy, subscriber to Maccabe health maintenance organization -

Exclusion Criteria:heavy vaginal bleeding; severe cervical stenosis; patients refusing the examination on an outpatient basis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Procedure:
• vaginoscopic hysteroscopy

Locations

Country	Name	City	State
Israel	Maccabe Health Maintenance Organization	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Sagiv R, Sadan O, Boaz M, Dishi M, Schechter E, Golan A. A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):387-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale for pain
Primary	Patient satisfaction