NCT04139083

Brief Summary

The investigators aim to assess the surgical outcomes of transvaginal mesh (TVM) and laparoscopic (LSC) mesh suspension. During the study period, all women with main uterine prolapse stage II or greater defined by the POP quantification staging system receiving TVM or LSC mesh suspension were retrospectively recruited. Clinical evaluations before and 6 months after surgery included pelvic examination, urodynamic study, and a personal interview to evaluate urinary and sexual symptoms using questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

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 1, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
Last Updated

October 28, 2019

Status Verified

January 1, 2019

Enrollment Period

7 years

First QC Date

October 23, 2019

Last Update Submit

October 24, 2019

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapseTransvaginal meshLaparoscopic mesh suspension

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    The POP-Q stage measurement after the operation

    12 months

Study Arms (2)

TVM group

Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system treated with TVM

Procedure: TVM

LSC mesh suspension group

Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system treated with LSC mesh suspension

Procedure: LSC mesh suspension

Interventions

LSC mesh suspensionPROCEDURE

Long mesh, a synthetic T-shaped mesh (Gynemsh, Ethicon, San Lorenzo, Puerto Rico), is delivered into the pelvic cavity. Bilateral mesh arms are extracted outside trocar wounds bilaterally to stabilize mesh position. The center piece is fixed to the cervix with 5mm ProTack screws (Covidien, New Haven, Connecticut). Fixation is strengthened with Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among surrounding tissues. An extraperitoneal tunnel is created along the left round ligament until reaching 2cm medial to the anterior superior iliac spine (ASIS). One arm of the long mesh is pulled out along the tunnel underneath round ligament and fixed with the fascia of oblique abdominis. The same procedure is repeated for the contralateral side. Bilateral round ligaments and the mesh arms are sutured continuously with Stratafix 2-0.

LSC mesh suspension group
TVMPROCEDURE

Transvaginal mesh kit is delivered into the pelvis via vagina route.

TVM group

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system

You may qualify if:

  • Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging system

You may not qualify if:

  • A hypertrophic uterus, huge fibroids
  • History of cervical dysplasia or endometrial pathology
  • History of postmenopausal bleeding in the past 12 months
  • Unwilling to preserve their uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (7)

  • Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN, Withagen MI. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP). Int Urogynecol J. 2016 Apr;27(4):655-84. doi: 10.1007/s00192-016-3003-y.

    PMID: 26984443BACKGROUND

  • Korbly NB, Kassis NC, Good MM, Richardson ML, Book NM, Yip S, Saguan D, Gross C, Evans J, Lopes VV, Harvie HS, Sung VW. Patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse. Am J Obstet Gynecol. 2013 Nov;209(5):470.e1-6. doi: 10.1016/j.ajog.2013.08.003. Epub 2013 Aug 3.

    PMID: 23921090BACKGROUND

  • Wu MP, Long CY, Huang KH, Chu CC, Liang CC, Tang CH. Changing trends of surgical approaches for uterine prolapse: an 11-year population-based nationwide descriptive study. Int Urogynecol J. 2012 Jul;23(7):865-72. doi: 10.1007/s00192-011-1647-1. Epub 2012 Jan 24.

    PMID: 22270728BACKGROUND

  • Long CY, Wang CL, Ker CR, Juan YS, Tsai EM, Lin KL. Laparoscopic Organopexy with Non-mesh Genital (LONG) Suspension: A Novel Uterine Preservation Procedure for the Treatment of Apical Prolapse. Sci Rep. 2018 Mar 20;8(1):4872. doi: 10.1038/s41598-018-23285-7.

    PMID: 29559709BACKGROUND

  • Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376.

    PMID: 27696355BACKGROUND

  • Long CY, Hsu CS, Wu CH, Liu CM, Wang CL, Tsai EM. Three-year outcome of transvaginal mesh repair for the treatment of pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol. 2012 Mar;161(1):105-8. doi: 10.1016/j.ejogrb.2011.12.007. Epub 2012 Jan 9.

    PMID: 22226537BACKGROUND

  • Ker CR, Lin KL, Loo ZX, Juan YS, Long CY. Comparison of UpholdTM Vaginal Mesh Procedure with Hysterectomy or Uterine Preservation for the Treatment of Pelvic Organ Prolapse. Sci Rep. 2018 Jun 21;8(1):9438. doi: 10.1038/s41598-018-27765-8.

    PMID: 29930249BACKGROUND

Related Links

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Cheng-Yu Long, PhD

    Kaohsiung Municipal University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

January 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)