Uterine Filling Pressure in Hysteroscopy

The Effect of Decreased Uterine Filling Pressure in Hysteroscopy, a Double-blind Control Trial

The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.

Study Overview

• Status: Terminated
• Conditions: Fibroids
• Intervention / Treatment: Device: MyoSure Hysteroscopic Morcellator Device

Detailed Description

An a priori sample size calculation was completed. To achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.The study will be a double-blind randomized control trial. Patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. The consent process will happen in the pre-operative appointment. Participants will then be randomized to either the standard of care of 80mmHg or the experimental pressure of 60 mmHg for uterine filling pressure via an automated randomization program. The physician performing the surgery and the patient will not know what group they are assigned to. The procedure involved in the study will be hysteroscopy. Hysteroscopy is a procedure that is used to diagnose and sometimes treat intrauterine pathologies. In order to visualize the uterus, pressurized saline is used to distend the uterus.

In this study, the specific hysteroscopic procedure will involve the removal of uterine fibroids with a MyoSure Hysteroscopic Morcellator device. These tissue samples will be collected and sent to Pathology to be weighed. During the surgery, the surgeon will be able to request an adjustment pressure if visualization is not adequate. Physicians will start with a pressure of 80mmHg. Once physician is ready to introduce the MyoSure hysteroscopy device, the pressure level will then be randomized. During the procedure, monitoring will be done by anesthesia through the use of pulse oximetry and measurement of vitals during the Monitored Anesthesia Care. There is also real-time monitoring of hysteroscopic fluid deficit via the fluid management system that is attached to the hysteroscopic pump. Fluid deficit can also be confirmed by the nurse who manually counts the amount of fluid used during the procedure. Per policy, once a 2500mL deficit is reached, the procedure is terminated. After the surgery, the surgeon will fill out a questionnaire that measures the outcomes of surgeon satisfaction and visualization during the procedure. The other end points of procedure time, specimen weight, volume of normal saline used, any changes in pressure needed during the surgery, and whether the patient required Lasix post-operatively will also be collected at this time.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Center for Comprehensive Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids
• Age equal to or greater than 18
• Ability to understand and willingness to sign consent form. Non-English speaking patients will be included in this study

Exclusion Criteria:

• Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids
• Patients under the age of 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 60 mmHg MyoSure Hysteroscopic Morcellator Device; The rationale for this experimental arm is that the pressurization can result in excess fluid being absorbed by the patient without a substantial benefit to surgical outcome. Minimizing the pressure from 80 mmHg (which is standard of care) to 60 mmHg used during this procedure may optimize outcome without compromising visualization of the surgeon. The research procedure will take place in the operating room of the minimally invasive gynecologic surgery department.	Device: MyoSure Hysteroscopic Morcellator Device; This device is normally used for this procedure, but the investigators included it as an intervention because the pressure will be lowered for one arm of the study (treatment) and the pressure in the other arm will be remain unchanged (control) as the standard of care.
Sham Comparator: 80 mmHg MyoSure Hysteroscopic Morcellator Device; This is the standard of care pressurization for this procedure at Northwestern Medicine and will be the control group for the study	Device: MyoSure Hysteroscopic Morcellator Device; This device is normally used for this procedure, but the investigators included it as an intervention because the pressure will be lowered for one arm of the study (treatment) and the pressure in the other arm will be remain unchanged (control) as the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Duration of surgery to assess if pressure changes affects length of surgery time.	Through study completion, an average of 1 year
Specimen Weight	Specimen will be sent to pathology to note weight in grams.	Through study completion, an average of 1 year
Amount of Fluid	Volume of normal saline used during procedure.	Through study completion, an average of 1 year
Physician Survey to Assess Visualization	Determining whether lowering pressure on hysteroscopic morcellator during hysteroscopy, using block randomization, affects visualization for surgeon using a post-op survey for surgeon to gauge outcomes.	Through study completion, an average of 1 year
Lasix Administered Post-operatively	Noting yes or no if Lasix was administered post-operatively.	Through study completion, an average of 1 year
Change in Pressure Was Needed	Noting if pressure needed changing by surgeon during the procedure.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Magdy P Milad, MD, MM, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: STU00211845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will only involve consent forms, which will be stored in a locked cabinet in the research coordinators office along with the updated protocol and other study materials. The survey for the surgeon performing the procedure will be stored in the same place and used for data analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes