The Efficacy of Laparoscopic Sacrocolpopexy in the Treatment of Pelvic Organ Prolapse in Women With or Without Avulsion of the Levator Ani Muscle

NCT03049020 | Unknown

• 1 other identifier: 1760/14S-IV
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Based on a prospective study, to evaluate how pre-operative pelvic floor status - the presence of injury to the musculus levator ani - may influence the results of laparoscopic sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the presence of such injury increases the risk of post-operative prolapse recurrence

Conditions

Pelvic Organ Prolapse Recurrence

Keywords

pelvic organ prolapse; sacrocolpopexy; pelvic floor ultrasound

Outcome Measures

Primary Outcomes (1)

• Objective cure rate

  The objective cure will be defined as absence of pelvic organ prolapse. Number of failures in each group: failure is defined as pelvic organ prolapse stage II or higher using the POPQ system during the clinical examination, or as a descent 1 cm below the lower edge of the pubic bone based on ultrasound examination

  One year

Secondary Outcomes (10)

• Genital hiatus size

  One year

• Distance of mesh from the bladder neck

  One year

• Lowest position of the mesh

  One year

• ICIQ-UI SF

  One year

• PISQ 12

  One year

Study Arms (2)

With levator ani avulsion

Patients indicated for sacrocolpopexy for pelvic organ prolapse and suffering with levator ani avulsion

Procedure: laparoscopic sacrocolpopexy

Without levator ani avulsion

Patients indicated for sacrocolpopexy for pelvic organ prolapse and without levator ani avulsion

Procedure: laparoscopic sacrocolpopexy

Interventions

laparoscopic sacrocolpopexy PROCEDURE

standard laparoscopic sacrocolpopexy for prolapse treatment

With levator ani avulsion; Without levator ani avulsion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age over 18, symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartment

You may qualify if:

• Age over 18
• signed informed consent
• symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartment
• agreement with postoperative follow-up

You may not qualify if:

• Previous pelvic reconstructive mesh surgery
• Isolated posterior compartment prolapse
• Previous radiotherapy in lesser pelvis
• Contraindication of laparoscopic sacrocolpopexy

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (2)

General University Hospital

Prague, Prague, 12800, Czechia

RECRUITING

Vladimir Kalis

Pilsen, Czechia

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaromir Masata, MD, Ph.D.

  Charles University, Czech Republic

  STUDY CHAIR

Central Study Contacts

Jaromir Masata, MD, Ph.D.

CONTACT

224967009; masata@volny.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kamil Svabik, MD, Ph.D.

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: February 9, 2017
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

CZ (2)