NCT05688059

Brief Summary

Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications. Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture. Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 6, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

January 8, 2023

Last Update Submit

April 10, 2025

Conditions

Pelvic Organ ProlapseUterovaginal ProlapseVaginal Vault ProlapseCystocele

Keywords

Sacrospinous Ligament SuspensionPermanent SutureAbsorbable SutureEfficacySuture-related Complications

Outcome Measures

Primary Outcomes (1)

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

    Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. A provider who is blinded to the type of suture used will conduct postop POPQ exam.

    12 months

Secondary Outcomes (3)

  • Prolapse Recurrence

    12 months

  • PGI-I

    12 months

  • Suture-related Complications

    12 months

Study Arms (2)

Absorbable Suture

EXPERIMENTAL

Absorbable suture for sacrospinous ligament suspension

Other: Absorbable Suture and Permanent Suture

Permanent Suture

EXPERIMENTAL

Permanent suture for sacrospinous ligament suspension

Other: Absorbable Suture and Permanent Suture

Interventions

Absorbable Suture and Permanent SutureOTHER

Absorbable Suture and Permanent Suture

Absorbable SuturePermanent Suture

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • Females
  • Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers

You may not qualify if:

  • Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision
  • Patients with current gynecologic malignancies
  • Patients with history of pelvic radiation
  • Patients with history of prolapse repair surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Related Publications (10)

  • Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. 2013 Nov;24(11):1783-90. doi: 10.1007/s00192-013-2169-9.

    PMID: 24142054BACKGROUND

  • Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.

    PMID: 24807341BACKGROUND

  • Beer M, Kuhn A. Surgical techniques for vault prolapse: a review of the literature. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):144-55. doi: 10.1016/j.ejogrb.2004.06.042.

    PMID: 15808370BACKGROUND

  • Tseng LH, Chen I, Chang SD, Lee CL. Modern role of sacrospinous ligament fixation for pelvic organ prolapse surgery--a systemic review. Taiwan J Obstet Gynecol. 2013 Sep;52(3):311-7. doi: 10.1016/j.tjog.2012.11.002.

    PMID: 24075365BACKGROUND

  • Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle S; NICHD Pelvic Floor Disorders Network. Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA. 2018 Apr 17;319(15):1554-1565. doi: 10.1001/jama.2018.2827.

    PMID: 29677302BACKGROUND

  • Hamdy MA, Ahmed WAS, Taha OT, Abolill ZM, Elshahat AM, Aboelroose AA. Late suture site complications of sacrospinous ligament fixation. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:126-130. doi: 10.1016/j.ejogrb.2019.08.024. Epub 2019 Sep 19.

    PMID: 31585239BACKGROUND

  • Sailesh Ray, Atin Halder, Mimi Gangopadhyay, Saswati Halder, and Partha Pratim Pal.Comparison of Two Different Suture Materials for Transvaginal Sacrospinous Fixation of the Vault: A Prospective Randomized Trial. Journal of Gynecologic Surgery.Dec 2013.281-286.http://doi.org/10.1089/gyn.2012.0150

    BACKGROUND

  • Kowalski JT, Genadry R, Ten Eyck P, Bradley CS. A randomized controlled trial of permanent vs absorbable suture for uterosacral ligament suspension. Int Urogynecol J. 2021 Apr;32(4):785-790. doi: 10.1007/s00192-020-04244-1. Epub 2020 Feb 11.

    PMID: 32047968BACKGROUND

  • Luck AM, Galvin SL, Theofrastous JP. Suture erosion and wound dehiscence with permanent versus absorbable suture in reconstructive posterior vaginal surgery. Am J Obstet Gynecol. 2005 May;192(5):1626-9. doi: 10.1016/j.ajog.2004.11.029.

    PMID: 15902168BACKGROUND

  • Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.

    PMID: 24618964BACKGROUND

MeSH Terms

Conditions

Pelvic Organ ProlapseCystocele

Condition Hierarchy (Ancestors)

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

Study Officials

  • Laura Dhariwal, MD

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

January 6, 2023

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)