NCT02911584

Brief Summary

This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

September 15, 2016

Last Update Submit

December 4, 2017

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Number of patients with anatomical correction of the prolapse

    Anatomical correction of the prolapse evaluated by gynecological visit

    up to 6 months

Secondary Outcomes (2)

  • Rate of recurrence

    up to 6 months

  • Post operative quality of life

    up to 6 months

Study Arms (2)

Sacral colpopexy

ACTIVE COMPARATOR

Laparoscopic procedure

Procedure: Laparoscopic procedure

POPS

ACTIVE COMPARATOR

Laparoscopic procedure: Pelvic Organs Prolapse Suspension

Procedure: Laparoscopic procedure

Interventions

Laparoscopic procedurePROCEDURE
POPSSacral colpopexy

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

You may not qualify if:

  • Age \> 70 years
  • Severe cardiovascular or respiratory disease
  • Pregnancy
  • Previous surgical procedure for POP correction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 22, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

December 6, 2017

Record last verified: 2017-11