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Comparison of Two Hysteroscopy Approaches

A New Approach to Office Hysteroscopy Compared With Traditional Hysteroscopy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00319410
Enrollment
130
Registered
2006-04-27
Start date
2005-07-31
Completion date
2005-12-31
Last updated
2006-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

Keywords

Menorrhagia, intrauterine diagnosis, visual analogue scale

Brief 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.

Detailed 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.

Interventions

PROCEDUREvaginoscopic hysteroscopy

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frame
Visual analogue scale for pain
Patient satisfaction

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026