NCT03005613

Brief Summary

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 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

December 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 16, 2026

Status Verified

February 1, 2023

Enrollment Period

6 years

First QC Date

December 15, 2016

Last Update Submit

January 14, 2026

Conditions

Urogenital Prolapse

Keywords

Pelvic organ prolapseSacrospinous ligament fixationIschial spine fascia fixationClinical outcome

Outcome Measures

Primary Outcomes (1)

  • objective success

    no prolapse, stage I or only asymptomatic stage II prolapse

    3 months after operation

Secondary Outcomes (6)

  • Pelvic Floor Distress Inventory-20 (PFDI-20)

    Change from Baseline in PFDI-20 at 3 months and 1 year

  • Pelvic Floor Impact Questionnaire-7 (PFIQ-7)

    Change from Baseline in PFIQ-7 at 3 months and 1 year

  • Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12)

    Change from Baseline in PISQ-12 at 3 months and 1 year

  • complications

    through study completion, an average of 1 year

  • recurrence rate

    3 months after operation

  • +1 more secondary outcomes

Study Arms (2)

sacrospinous ligament fixation group

ACTIVE COMPARATOR

The patients will receive sacrospinous ligament fixation operation.

Procedure: sacrospinous ligament fixation

ischial spine fascia fixation group

EXPERIMENTAL

The patients will receive ischial spine fascia fixation operation.

Procedure: ischial spine fascia fixation

Interventions

ischial spine fascia fixationPROCEDURE

The participants will receive ischial spine fascia fixation.

ischial spine fascia fixation group
sacrospinous ligament fixationPROCEDURE

The participants will receive sacrospinous ligament fixation.

sacrospinous ligament fixation group

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age≤65 years, for those scheduled to receive hysterectomy age≥40 years
  • patients with symptomatic stage II\~IV uterine or vaginal vault prolapse
  • receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital

You may not qualify if:

  • plans to live abroad within follow-up span
  • contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
  • patients with hip joint problem who could not pose a lithotomy position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ob & Gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (8)

  • Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.

    PMID: 3342213BACKGROUND

  • Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.

    PMID: 9052607BACKGROUND

  • Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

    PMID: 9083302BACKGROUND

  • Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.

    PMID: 20966694BACKGROUND

  • Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.

    PMID: 12548203BACKGROUND

  • Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.

    PMID: 24142057BACKGROUND

  • Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.

    PMID: 20223444BACKGROUND

  • Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.

    PMID: 21060988BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Chang Ren, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 29, 2016

Study Start

January 15, 2017

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

January 16, 2026

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)