Intrauterine Stent Placement Following Hysteroscopic Septum Resection

A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection

The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.

Study Overview

• Status: Recruiting
• Conditions: Intrauterine Adhesion
• Intervention / Treatment: Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter; Drug: Hormonal Therapy Agent; Drug: Oral antibiotics; Procedure: No Catheter placement

Detailed Description

This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.

Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:

Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodriq Stubbs, NP, MSN; Phone Number: 646-962-3276; Email: res2011@med.cornell.edu
• Study Contact Backup: Name: Sarah Cambria; Phone Number: 646-962-2961; Email: sac7011@med.cornell.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-0000
      • Not yet recruiting
      • Arkansas Fertility & Gynecology
      • Contact: Christopher Moutos, MD; Phone Number: (501) 534-3764; Email: res2011@med.cornell.edu
      • Principal Investigator: Christopher Moutos, MD
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Principal Investigator: Glenn Schattman, MD
      • Contact: Rodriq Stubbs, NP; Email: res2011@med.conrell.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • University Hospitals
      • Contact: Mindy Christianson, MD; Phone Number: (216) 672-1427; Email: christm12@ccf.org
      • Principal Investigator: Christianson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 and above
• Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
• Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound

Exclusion Criteria:

• Unwilling or unable to provide informed consent
• History of prior uterine septum resection
• History of prior transmural uterine surgery
• Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
• Individuals in whom complete septum resection is unable to be performed as a single procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter; Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.	Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter; Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.; Drug: Hormonal Therapy Agent; 2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily); Drug: Oral antibiotics; 100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place
Active Comparator: Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter; No placement of an inflated intrauterine pediatric foley catheter	Drug: Hormonal Therapy Agent; 2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily); Procedure: No Catheter placement; No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of intrauterine adhesion formation following hysteroscopic septoplasty	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects completing postop intervention-hormone use		12 weeks
Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit		12 weeks
Long Term Reproductive Outcome	Number of subjects achieving pregnancy	3 years
Surgeon assessment of intervention modality	Surgeon assessment of whether intrauterine adhesions were prevented	12 weeks
Number of participants with Intraoperative complications		12 weeks
Number of participants with postoperative complications		12 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Glenn Schattman, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: June 14, 2025
• First Submitted That Met QC Criteria: June 14, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: uterine malformations; intrauterine foley balloon catheter stent; uterine septums; hysteroscopic septoplasty
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Uterine Duplication Anomalies; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Septate Uterus; Gynatresia; Uterine Anomalies; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Bacterial Agents
• Other Study ID Numbers: 24-04027291

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
• product manufactured in and exported from the U.S.: No