NCT03644628

Brief Summary

The aim of the study will be to compare the SCP and LLS in the management of apical prolapse at 6 weeks, 6 months, 1 year and yearly up to 2 years with the null hypothesis being that no significant differences existed between the two surgical procedures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Status
unknown

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 3, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

August 3, 2018

Last Update Submit

September 18, 2018

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

  • Subjective cure rate of prolapse

    Provided by the patient's feeling of the "Absence of a bulge in the vagina"

    at 12 months postoperatively

  • Objective success

    Defined as anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total

    at 12 months postoperatively

Secondary Outcomes (5)

  • Patient global satisfaction

    1, 6, 12, 24 and 60 months

  • Prolapse-related Quality of life

    1, 6, 12, 24 and 60 months

  • Perioperative complications

    perioperatively

  • Sexual function

    1, 6, 12, 24 and 60 months

  • Patient satisfaction related to improvement of condition

    1, 6, 12, 24 and 60 months

Study Arms (2)

Sacropexy group (SCP)

ACTIVE COMPARATOR

Anterior and apical repair with laparoscopic sacropexy

Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse

Lateral suspension group (LLS)

EXPERIMENTAL

Anterior and apical repair with laparoscopic lateral suspension

Procedure: Laparoscopic repair of anterior and apical pelvic organ prolapse

Interventions

Laparoscopic repair of anterior and apical pelvic organ prolapsePROCEDURE

Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy

Lateral suspension group (LLS)Sacropexy group (SCP)

Eligibility Criteria

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

You may qualify if:

  • Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal or vault prolapse)
  • Women with or without anterior compartment prolapse (point Ba -1 or more pelvic organ prolapse quantification POP-Q)
  • Women without significant posterior compartment prolapse (point Bp -1 or more pelvic organ prolapse quantification POP-Q)

You may not qualify if:

  • Women not eligible for surgery for medical or anesthesiological reasons
  • Inability to comprehend questionnaires
  • Inability to give informed consent
  • Inability to return for review
  • Prior laparoscopic prolapse repair
  • Prior vaginal mesh prolapse procedure
  • Vaginal length less than 6 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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

  • Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

    PMID: 18799443BACKGROUND

  • Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of menopausal women. Am J Obstet Gynecol. 2004 Jan;190(1):27-32. doi: 10.1016/j.ajog.2003.07.017.

    PMID: 14749630BACKGROUND

  • Morrill M, Lukacz ES, Lawrence JM, Nager CW, Contreras R, Luber KM. Seeking healthcare for pelvic floor disorders: a population-based study. Am J Obstet Gynecol. 2007 Jul;197(1):86.e1-6. doi: 10.1016/j.ajog.2007.02.051.

    PMID: 17618770BACKGROUND

  • 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

  • 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

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

    PMID: 24142057BACKGROUND

  • Vieillefosse S, Thubert T, Dache A, Hermieu JF, Deffieux X. Satisfaction, quality of life and lumbar pain following laparoscopic sacrocolpopexy: suture vs. tackers. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:51-6. doi: 10.1016/j.ejogrb.2015.02.014. Epub 2015 Feb 18.

    PMID: 25748488BACKGROUND

  • Dubuisson JB, Yaron M, Wenger JM, Jacob S. Treatment of genital prolapse by laparoscopic lateral suspension using mesh: a series of 73 patients. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):49-55. doi: 10.1016/j.jmig.2007.11.003.

    PMID: 18262144BACKGROUND

  • Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.

    PMID: 28417156BACKGROUND

  • Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21.

    PMID: 15875234BACKGROUND

  • Veit-Rubin N, Digesu A, Swift S, Khullar V, Kaelin Gambirasio I, Dallenbach P, Boulvain M. Validation of the French version of the P-QoL questionnaire. Eur J Obstet Gynecol Reprod Biol. 2015 Sep;192:10-6. doi: 10.1016/j.ejogrb.2015.05.028. Epub 2015 Jun 10.

    PMID: 26142910BACKGROUND

  • Digesu GA, Santamato S, Khullar V, Santillo V, Digesu A, Cormio G, Loverro G, Selvaggi L. Validation of an Italian version of the prolapse quality of life questionnaire. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):184-92. doi: 10.1016/s0301-2115(02)00229-4.

    PMID: 12551790BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Nikolaus Veit-Rubin, MD, MBA

CONTACT

+436645007424nikolaus.veitrubin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior resident Urogynecology

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 23, 2018

Study Start

January 1, 2019

Primary Completion

August 31, 2020

Study Completion

September 30, 2024

Last Updated

September 19, 2018

Record last verified: 2018-09