Trial Outcomes & Findings for A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension (NCT NCT02888093)

Results Overview

Non-inferiority of POP-Q point C. This measure was obtained as originally described by Bump et al. The hymen is used as a fixed reference point. In other words, this is point zero. Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

12 months

Results posted on

2019-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Absorbable Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Permanent Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Overall Study STARTED	22	22
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Absorbable n=22 Participants Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Permanent n=22 Participants Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=44 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=22 Participants	11 Participants n=22 Participants	24 Participants n=44 Participants
Age, Categorical >=65 years	9 Participants n=22 Participants	11 Participants n=22 Participants	20 Participants n=44 Participants
Age, Continuous	62.1 years STANDARD_DEVIATION 13.7 • n=22 Participants	63.6 years STANDARD_DEVIATION 10.2 • n=22 Participants	62.9 years STANDARD_DEVIATION 12.0 • n=44 Participants
Sex: Female, Male Female	22 Participants n=22 Participants	22 Participants n=22 Participants	44 Participants n=44 Participants
Sex: Female, Male Male	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	22 participants n=22 Participants	22 participants n=22 Participants	44 participants n=44 Participants

PRIMARY outcome

Timeframe: 12 months

Non-inferiority of POP-Q point C. This measure was obtained as originally described by Bump et al. The hymen is used as a fixed reference point. In other words, this is point zero. Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.

Outcome measures

Outcome measures
Measure	Absorbable n=20 Participants Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Permanent n=20 Participants Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C	-7.25 cm Interval -9.0 to -5.5	-7 cm Interval -10.0 to -6.0

SECONDARY outcome

Timeframe: 6 weeks and 12 months

The presence of apical granulation tissue, apical suture exposure, abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia or patient being able to feel suture.

Outcome measures

Outcome measures
Measure	Absorbable n=20 Participants Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Permanent n=20 Participants Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Suture-related Complications 6 weeks	17 Participants	14 Participants
Suture-related Complications 12 months	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Positive response to PFDI-20 question #3 regarding the presence of a vaginal bulge (yes) AND the presence of bother (somewhat, moderately or quite a bit).

Outcome measures

Outcome measures
Measure	Absorbable n=20 Participants Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Permanent n=20 Participants Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Symptomatic Prolapse Outcomes	1 Participants	4 Participants

Adverse Events

Absorbable

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Permanent

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Absorbable n=22 participants at risk Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)	Permanent n=22 participants at risk Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS) Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Reproductive system and breast disorders Any suture related complication	9.1% 2/22 • Number of events 2 • 1 year	18.2% 4/22 • Number of events 4 • 1 year

Additional Information

Dr. Joseph Kowalski

University of Iowa Hospitals and Clinics

Phone: 3193561616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place