NCT02888093

Brief Summary

Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor complication such as persistent vaginal spotting, vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized delayed-absorbable sutures in order to avoid these complications. Retrospective studies are conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as permanent suture. There are currently no high-quality, prospective studies that have evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension. This study will recruit women scheduled to undergo USLS with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month follow up visit. Subjects and assessors will be blinded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 2, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

August 30, 2016

Results QC Date

October 11, 2019

Last Update Submit

November 12, 2019

Conditions

Pelvic Organ ProlapseCystoceleUterine Prolapse

Outcome Measures

Primary Outcomes (1)

  • Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C

    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.

    12 months

Secondary Outcomes (2)

  • Suture-related Complications

    6 weeks and 12 months

  • Symptomatic Prolapse Outcomes

    12 months

Study Arms (2)

Absorbable

EXPERIMENTAL

Absorbable suture (polydioxanone) for uterosacral ligament suspension (USLS)

Device: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)

Permanent

EXPERIMENTAL

Permanent suture (Gore-Tex CV2) for uterosacral ligament suspension (USLS)

Device: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)

Interventions

Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)DEVICE
AbsorbablePermanent

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for uterosacral ligament suspension (USLS)

You may not qualify if:

  • Non-English speaking
  • Prisoner
  • Cognitive impairment precluding informed consent
  • Planned hysteropexy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseCystoceleUterine Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUterine DiseasesGenital Diseases, FemaleGenital Diseases

Results Point of Contact

Title
Dr. Joseph Kowalski
Organization
University of Iowa Hospitals and Clinics
joseph-kowalski@uiowa.edu
3193561616

Study Officials

  • Joseph T Kowalski, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Female Pelvic Medicine and Reconstructive Surgery, Fellow

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 2, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2018

Last Updated

December 2, 2019

Results First Posted

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)