Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)

The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.

Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation.

A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.

We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to study its feasibility in terms of surgeon's and patient's experience.

Study Overview

• Status: Completed
• Conditions: Adhesion; Uterus, Internal
• Intervention / Treatment: Device: intra uterine Cook balloon

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrauterine balloon (Cook medical); Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.	Device: intra uterine Cook balloon; Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of recurrent adhesions after adhesiolysis	5-10 weeks after adhesiolysis
The number of complications after adhesiolysis	5-10 weeks after adhesiolysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after placement of the intra uterine balloon	via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).	1 to 6 days after adhesiolysis
Complications after placement of the intra uterine balloon		1 to 6 days after adhesiolysis
Pain at the time of the removal of the intra uterine balloon	via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).	6 days after adhesiolysis
Patient Satisfaction after removal of the intra uterine balloon	Via questionnaire	6 days after adhesiolysis
Malaise after placement of the intra uterine balloon	Via questionnaire	6 days after adhesiolysis
Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)	Via questionnaire and via via Visual Analogue Scale (VAS scale). The patient has to indicate her daily functioning from 0 (the balloon had no influence on my daily function) to 10 (because of the balloon I couldn't do anything of my daily work).	6 days after adhesiolysis
The ease of inserting the intra uterine balloon	Via questionnaire	once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study
The ease of removing the intra uterine balloon	Via questionnaire	6 days after adhesiolysis

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Actual): December 16, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: intrauterine balloon; intrauterine adhesions; antiadhesion treatment; Asherman's syndrome; hysteroscopic adhesiolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: B670201733915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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