Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01559168
First received: March 19, 2012
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Device: UpholdTM LITE placement |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- Apical anatomical success [ Time Frame: 12 months ] [ Designated as safety issue: No ]Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
- Anterior vaginal wall anatomical success [ Time Frame: 12 months ] [ Designated as safety issue: No ]Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
- Change from baseline in PFDI-20 scores [ Time Frame: baseline to 12 lines ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Anterior vaginal wall anatomical success [ Time Frame: 6 months ] [ Designated as safety issue: No ]Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
- Apical anatomical success [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
- Apical anatomical success [ Time Frame: 6 months ] [ Designated as safety issue: No ]Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
- Anterior vaginal wall anatomical success [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
- Change from baseline in PFDI-20 scores [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
- Change from baseline in PFDI-20 scores [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Change from baseline in PFIQ-7 scores [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
- Change from baseline in PFIQ-7 scores [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Change from baseline in PFIQ-7 scores [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
- Change from baseline in PISQ-12 scores [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Change from baseline in PISQ-12 scores [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
- length of hospital stay (days) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Number of days necessary for return to normal activities [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Visual analog scale for post-operative pain [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]score ranging from 0.0 to 10.0
- Visual analog scale for post-operative pain [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]score ranging from 0.0 to 10.0
- Visual analog scale for post-operative pain [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]score ranging from 0.0 to 10.0
- Visual analog scale for post-operative pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]score ranging from 0.0 to 10.0
- Mesh related morbidity [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
- Mesh related morbidity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
- Mesh related morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
- Mesh related morbidity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
- Mesh contraction (cm) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Mesh contraction as determined by ultrasound measurement (cm)
- Mesh contraction (cm) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mesh contraction as determined by ultrasound measurement (cm)
- Mesh contraction (cm) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mesh contraction as determined by ultrasound measurement (cm)
- Patient satisfaction (PGI index) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Patient satisfaction (PGI index) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient satisfaction (PGI index) score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prolapse patients recieving UpHold LITE
Non-pregnant female patients >= 50 years who are not considering future pregnancies, who are diagnosed with uterine or vault prolapse with ICS POP-Q score of stage 2 or greater, who are receiving the UpholdTM LITE mesh kit and who agree to be in the study.
|
Device: UpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559168
Contacts
| Contact: Renaud de Tayrac, MD PhD | +33.(0)4.66.68.32.16 | renaud.detayrac@chu-nimes.fr |
| Contact: Carey M Suehs, Ph D | +33.(0)4.66.68.67.88 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| CH Camille Guérin | Not yet recruiting |
| Châtellerault Cedex, France, 86106 | |
| Sub-Investigator: Caroline Carlier Guerin, MD | |
| CHU de Clermont Ferrand - Hôpital Estaing | Not yet recruiting |
| Clermont Ferrand, France, 63003 | |
| Sub-Investigator: Denis Savary, MD | |
| CH de Dunkerque | Not yet recruiting |
| Dunkerque, France, 59385 | |
| Sub-Investigator: Philippe Debodinance, MD | |
| CH de Gonesse | Not yet recruiting |
| Gonesse, France, 95500 | |
| Sub-Investigator: François Monneins, MD | |
| CHRU de Lyon - Hôpital de la Croix Rousse | Not yet recruiting |
| Lyon Cedex 4, France, 69317 | |
| Sub-Investigator: Gil Dubernard, MD PhD | |
| APHM - Hôpital de la Conception | Not yet recruiting |
| Marseille Cedex 5, France, 13385 | |
| Sub-Investigator: Maxime Marcelli, MD | |
| Sub-Investigator: Aubert Agostini, MD PhD | |
| CHU de Montpellier - Hôpital Lapeyronie | Not yet recruiting |
| Montpellier, France, 34295 | |
| Sub-Investigator: Mélanie Cayrac, MD | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Recruiting |
| Nîmes Cedex 09, France, 30029 | |
| Sub-Investigator: Vincent Letouzey, MD | |
| Principal Investigator: Renaud de Tayrac, MD PhD | |
| Sub-Investigator: Brigitte Fatton, MD | |
| CH Louis Giorgi | Not yet recruiting |
| Orange, France, 84106 | |
| Sub-Investigator: Vincent Descheemaeker, MD | |
| CHU de Poitiers | Not yet recruiting |
| Poitiers, France, 86021 | |
| Sub-Investigator: Xavier Fritel, MD PhD | |
| Hôpital Foch | Not yet recruiting |
| Suresnes, France, 92150 | |
| Sub-Investigator: Florence Cour, MD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Renaud de Tayrac, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01559168 History of Changes |
| Other Study ID Numbers: | LOCAL/2011/RdeT-04, 2011-A01705-36 |
| Study First Received: | March 19, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: L’Agence nationale de sécurité du médicament et des produits de santé |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013