Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

• Sponsor: Wenzhou Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02867202
• Collaborator: (none)
• Enrollment: 171
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

Condition or Disease	Intervention/Treatment	Phase
Asherman Syndrome	Device: Intrauterine balloon; Device: Intrauterine Contraceptive Device Plus Foley Catheter	N/A

Detailed Description

Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion.

The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later.

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intrauterine balloon The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions.	Device: Intrauterine balloon; After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.; Other Names: Cook balloon
Experimental: intrauterine device Plus Foley Catheter Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.	Device: Intrauterine Contraceptive Device Plus Foley Catheter; After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.; Other Names: Intrauterine Device Plus Foley Catheter

Outcome Measures

Primary Outcome Measures

1. the AFS Score at Second-look Hysteroscopy [2 or 3 months after the surgery]

   The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Moderate to severe intrauterine adhesion (AFS score ≥5）

• Agreement to have a second-look hysteroscopy

• no previous history of hysteroscopic adhesiolysis

Exclusion Criteria:

• Minimal adhesion (AFS score<5)

• Previous hysteroscopic adhesiolysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the 1st Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

• Wenzhou Medical University

Investigators

• Principal Investigator: Feng Lin, MD, the 1st Affiliated Hospital of Wenzhou Medical University

Study Documents (Full-Text)

• Statistical Analysis Plan - Dec 1, 2017
• Study Protocol - Dec 1, 2017

More Information

Publications

• Johary J, Xue M, Zhu X, Xu D, Velu PP. Efficacy of estrogen therapy in patients with intrauterine adhesions: systematic review. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):44-54. doi: 10.1016/j.jmig.2013.07.018. Epub 2013 Aug 9. Review.
• Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
• Lin XN, Zhou F, Wei ML, Yang Y, Li Y, Li TC, Zhang SY. Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.

• Responsible Party: Feng Lin, attending doctor, Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT02867202
• Other Study ID Numbers: Wenzhou MC
• First Posted: Aug 15, 2016
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Feng Lin, attending doctor, Wenzhou Medical University: intrauterine balloon; Intrauterine Device Plus Foley Balloon Catheter; Asherman Syndrome
• Additional relevant MeSH terms: Gynatresia; Contraceptive Agents

Study Results

Participant Flow

Recruitment Details	all patients were recruited from 1st affiliated hospital of Wenzhou Medical University. Inclusion criteria were as follows:1) women aged 18 to 45 years. 2) agreed to have second-look hysteroscopy. 3) moderate to severe intrauterine adhesion (AFS score ≥5)
Pre-assignment Detail	not meeting inclusion criteria declined to participate

Arm/Group Title	Intrauterine Balloon	Intrauterine Contraceptive Device Plus Foley Catheter
Arm/Group Description	After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.	Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
Period Title: Overall Study
STARTED	83	88
COMPLETED	62	56
NOT COMPLETED	21	32

Baseline Characteristics

Arm/Group Title	Intrauterine Balloon	IUD Plus Foley Catheter	Total
Arm/Group Description	After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.	Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.	Total of all reporting groups
Overall Participants	62	56	118
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	31.69 (5.268)	32.63 (6.125)	32.14 (5.685)
Sex: Female, Male (Count of Participants)
Female	62 100%	56 100%	118 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	62 100%	56 100%	118 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	62 100%	56 100%	118 100%
Parity (Births) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Births]	0.484 (0.565)	0.554 (0.536)	0.517 (0.551)

Outcome Measures

1. Primary Outcome

Title	the AFS Score at Second-look Hysteroscopy
Description	The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.
Time Frame	2 or 3 months after the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intrauterine Balloon	Intrauterine Device Plus Foley Catheter
Arm/Group Description	The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions. Intrauterine balloon: After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.	Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while Intrauterine Device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy. Intrauterine Contraceptive Device Plus Foley Catheter: After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.
Measure Participants	62	56
Median (Full Range) [Units on a scale]	6.5	8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intrauterine Balloon, Intrauterine Device Plus Foley Catheter
	Comments	Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value < 0.05 was considered statistically significant.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	6 months to 1 year
Adverse Event Reporting Description	Among 171 participants who were initially recruited, 18 were excluded from analysis; 8 patients declined to participate and 10 patients did not meet the inclusion criteria. 30 participants subsequently refused to undergo the second-look hysteroscopy, and 5 subjects were also excluded for protocol violation. 17 women in the study reported side effects. 15 subjects suffered from moderate to severe postoperative pain; 12in the COOK balloon stent group and 3 in the IUD plus Foley catheter group.
Arm/Group Title	Intrauterine Balloon		IUD Plus Foley Catheter
Arm/Group Description	After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions.		Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
All Cause Mortality
	Intrauterine Balloon		IUD Plus Foley Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/88 (0%)
Serious Adverse Events
	Intrauterine Balloon		IUD Plus Foley Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/88 (0%)
Other (Not Including Serious) Adverse Events
	Intrauterine Balloon		IUD Plus Foley Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/83 (25.3%)		32/88 (36.4%)
Injury, poisoning and procedural complications
suffered from moderate to severe postoperative pain	12/83 (14.5%)	12	3/88 (3.4%)	3
Investigations
refuse to have second-look hysteroscopy	9/83 (10.8%)	9	21/88 (23.9%)	21
Protocol violation	3/83 (3.6%)	3	2/88 (2.3%)	2
Declined to participate	4/83 (4.8%)	4	4/88 (4.5%)	4
Not meeting inclusion criteria	5/83 (6%)	5	5/88 (5.7%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.