Trial Outcomes & Findings for Postoperative Intermittent Intrauterine Balloon Dilatation Therapy. (NCT NCT03131596)

Last Updated: 2019-09-13

Results Overview

The American Fertility Society (AFS) score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score should be 0. The reformation of intrauterine adhesions was evaluated by third-look hysteroscopy, if the score was greater than 0, a adhesion reformation was considered.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

at 8 weeks post-operation

Results posted on

2019-09-13

Participant Flow

208 patients with moderate to severe (American Fertility Society score ≥ 5) Asherman syndrome who underwent hysteroscopic adhesiolysis were recruited from May 1st,2017 to January 1st,2018.

1 patients was excluded follow the criteria strictly and 7 patients declined to participant. In total, 8 patients were excluded before assignment to groups.

Participant milestones

Participant milestones
Measure	IUB Dilatation Therapy The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 8-12fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.
Overall Study STARTED	100	100
Overall Study COMPLETED	94	97
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	IUB Dilatation Therapy The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 8-12fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.
Overall Study Protocol Violation	3	3
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IUB Dilatation Therapy n=94 Participants The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group n=97 Participants Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and an optional third-look hysteroscopy will be carried out 8 weeks after the surgery.	Total n=191 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 4.7 • n=5 Participants	32.0 years STANDARD_DEVIATION 4.4 • n=7 Participants	32.0 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	97 Participants n=7 Participants	191 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	94 Participants n=5 Participants	97 Participants n=7 Participants	191 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
AFS score before operation	10 units on a scale n=5 Participants	10 units on a scale n=7 Participants	10 units on a scale n=5 Participants
PBAC score before operation	19.4 units on a scale STANDARD_DEVIATION 8.6 • n=5 Participants	18.8 units on a scale STANDARD_DEVIATION 7.8 • n=7 Participants	19.1 units on a scale STANDARD_DEVIATION 8.3 • n=5 Participants

PRIMARY outcome

Timeframe: at 8 weeks post-operation

Population: Intention-to-treat analysis was conducted on all outcomes.

Outcome measures

Outcome measures
Measure	IUB Dilatation Therapy n=94 Participants The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group n=97 Participants Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery	21 Participants	38 Participants

PRIMARY outcome

Timeframe: at 8 weeks post-operation

Population: The AFS score of each group was evaluated again after the whole procedure in order to reflect the efficacy of the treatment.

The American Fertility Society(AFS) score of each group was evaluated again at third-look hysteroscopy in order to reflect the efficacy of the treatment. The original AFS score was recorded in baseline characteristics part. The AFS score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score score should be 0.

Outcome measures

Outcome measures
Measure	IUB Dilatation Therapy n=94 Participants The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group n=97 Participants Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
The American Fertility Society Score 8 Weeks After Operation	0 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: at 8 weeks post-operation

The Pictorial Blood Loss Assessment Chart (PBAC) score was used to represent the menstrual flow volume of the patient. The PBAC score was evaluated again at 8 weeks after surgery. A higher PBAC score after hysteroscopic adhesiolysis means a better outcome.The PBAC score of a normal women usually range from 30-100 points. The minium value of PBAC score is 0, which means the patient is amenorrhea. The maximum value of PBAC score is 1000. We measured the score before and 8 weeks after the operation in order to assess if there was any improvement (higher than before) in menstrual flow.

Outcome measures

Outcome measures
Measure	IUB Dilatation Therapy n=94 Participants The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group n=97 Participants Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation	51.3 score on a scale Standard Deviation 7.5	31.6 score on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: within 12 months after third look hysteroscopy(8 weeks post-operation)

number of patients who have pregnancy, miscarriage and ectopic pregnancy within12 months follow-up

Outcome measures

Outcome measures
Measure	IUB Dilatation Therapy n=94 Participants The patient will have a Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy was carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will carried out 8 weeks after the surgery. IUB dilatation therapy: A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.	Control Group n=97 Participants Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy number of pregnancy	27 Participants	26 Participants
Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy number of live birth and ongoing pregnancy	18 Participants	16 Participants
Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy number of patients have miscarriage	8 Participants	9 Participants
Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy number of patients have ectopic pregnancy	1 Participants	1 Participants

Adverse Events

IUB Dilatation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shi Xiaoyu

Fuxing Hospital, Capital Medical University, Beijing, China

Phone: +86 18618496384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place