Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559168
• Other study ID #: LOCAL/2011/RdeT-04
• Secondary ID: 2011-A01705-36
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: January 31, 2017
• Start date: October 2012
• Est. completion date: July 15, 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.

Description:

Secondary objectives include the evaluation of the following:

• Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.

• The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.

• Change from baseline of mean quality-of-life scores.

• Evaluation of mesh properties from procedure date through study period.

• Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).

• Assessment of patient subjective outcomes for overall treatment effects and satisfaction.

• Objective evaluation of mesh shrinkage by standardized ultrasound measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 15, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• The patient is available for 12 months of follow-up

• Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse

• Patients who are receiving the UpholdTM LITE mesh Kit

• Female patients >= years who have no desire of future pregnancy

• Diagnosed with pelvic organ prolapse and >= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba >= -1

• Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, under tutorship or curatorship

• The patient refuses to sign the consent

• It is impossible to correctly inform the patient

• The patient is pregnant, parturient, or breastfeeding

• Patients who are not receiving the UpHoldTM LITE mesh Kit

• Patients < 50 years

• Patients qho, according to the clinical judgment of the investigator, are not suitable for this study

• Patients who are considering future pregnancies

• Patients whose pelvic organ prolapse is a <= 1 ICS Stage

• Patients requiring Posterior Graft procedure

• Patients with known or suspected hypersensitivity to polypropylene

• Patients with any pathology which ould compromise implant placement

• Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual

• Patients with any pathology that would limit blood supply and compromise healing

• Patients with blood coagulation disorder (associated current level coagulation)

• Patients with autoimmune connective tissue disease

• Patients with upper urinary tract obstruction and renal insufficiency

• Patients with local or systemic infection

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• UpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

Locations

Country	Name	City	State
France	CH Camille Guérin	Châtellerault Cedex
France	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand
France	CH de Dunkerque	Dunkerque
France	CH de Gonesse	Gonesse
France	CHRU de Lille - Hôpital Jeanne de Flandre	Lille Cedex
France	CHRU de Lyon - Hôpital de la Croix Rousse	Lyon Cedex 4
France	APHM - Hôpital de la Conception	Marseille Cedex 5
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	Clinique Beau Soleil	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CH Louis Giorgi	Orange
France	CHU de Poitiers	Poitiers
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apical anatomical success	Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)	12 months
Primary	Anterior vaginal wall anatomical success	Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)	12 months
Primary	Change from baseline in PFDI-20 scores		baseline to 12 lines
Secondary	Anterior vaginal wall anatomical success	Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)	6 months
Secondary	Apical anatomical success	Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)	6 weeks
Secondary	Apical anatomical success	Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)	6 months
Secondary	Anterior vaginal wall anatomical success	Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)	6 weeks
Secondary	Change from baseline in PFDI-20 scores		baseline to 6 weeks
Secondary	Change from baseline in PFDI-20 scores		baseline to 6 months
Secondary	Change from baseline in PFIQ-7 scores		baseline to 6 weeks
Secondary	Change from baseline in PFIQ-7 scores		baseline to 6 months
Secondary	Change from baseline in PFIQ-7 scores		baseline to 12 months
Secondary	Change from baseline in PISQ-12 scores		baseline to 6 months
Secondary	Change from baseline in PISQ-12 scores		baseline to 12 months
Secondary	length of hospital stay (days)		6 weeks
Secondary	Number of days necessary for return to normal activities		6 weeks
Secondary	Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	Day 1
Secondary	Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	6 weeks
Secondary	Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	6 months
Secondary	Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	12 months
Secondary	Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	Day 1
Secondary	Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	6 weeks
Secondary	Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	6 months
Secondary	Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	12 months
Secondary	Mesh contraction (cm)	Mesh contraction as determined by ultrasound measurement (cm)	6 weeks
Secondary	Mesh contraction (cm)	Mesh contraction as determined by ultrasound measurement (cm)	6 months
Secondary	Mesh contraction (cm)	Mesh contraction as determined by ultrasound measurement (cm)	12 months
Secondary	Patient satisfaction (PGI index) score		6 weeks
Secondary	Patient satisfaction (PGI index) score		6 months
Secondary	Patient satisfaction (PGI index) score		12 months