A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

Pelvic Organ Prolapse Clinical Trial

Official title:

A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04358978
• Other study ID #: Ospedale "F. Miulli"
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2020
• Source: Catholic University of the Sacred Heart
• Contact: Maurizio Guido
• Phone: 3393894243
• Email: maurizioguido[@]libero.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

-patients who required surgical treatment for symptomatic pelvic organ prolapse stage = 2 with or without stress urinary incontinence

Exclusion Criteria:

• Age > 75 years

• Severe cardiovascular or respiratory disease

• Pregnancy

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• laparoscopic sacral colpopexy with posterior mesh no attachment
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
• laparoscopic sacral colpopexy with posterior mesh attachment
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina

Locations

Country	Name	City	State
Italy	ospedale regionale Miulli	Acquaviva delle Fonti	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Miulli General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correction of pelvic organ prolapse	number of women with correction of prolapse mesured in S POP-Q stage during FU visit	1 year
Secondary	rate of recurrence	number of women with de novo anterior or posterior or central prolapse	1 year
Secondary	long term outcomes	number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain	1 year