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UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse (PRO-CURE II)

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ClinicalTrials.gov Identifier: NCT02255994
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.

Condition or disease Intervention/treatment Phase
Cystocele Device: UGYTEX Procedure: No mesh. Not Applicable

Detailed Description:

Secondary objectives include comparing the following elements between the two randomized groups at a long-term time point (5-8 years):

A. The anatomic failure rate of cystocele (POP-Q stage > or = 2) B. Late postoperative morbidity C. Residual post-operative pain (visual analog scale (VAS)) D. Patient satisfaction via the PGI-I questionnaire E. Quality of life via the PFDI and PFIQ questionnaires F. Sexual activity via the PISQ-12 questionnaire G. The rate of vaginal erosion H. Displacement and secondary shrinkage of meshs


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: UGYTEX
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
Device: UGYTEX
Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)

Active Comparator: No MESH
Patients in this arm had subvesical plication without reinforcement.
Procedure: No mesh.
Patients in this arm had subvesical plication without reinforcement.




Primary Outcome Measures :
  1. Functional failure [ Time Frame: 5 years ]
    The primary efficacy endpoint of this study, is the functional failure at 5 years, defined using the functional response at 12 months in NCT00153257, the concept of surgery for prolapse and the answer to question No. 5 of the PFDI questionnaire submitted between 5 and 8 years postoperatively.


Secondary Outcome Measures :
  1. Anatomical failure [ Time Frame: 5-8 years ]
    The anatomical failure is defined by a failure or recurrence at 12 months (data from NCT00153257), or surgery for prolapse or anatomic recurrence (recurrence of cystocele stage 2 or higher) upon examination at 5 to 8 years.

  2. Post-operative complications [ Time Frame: 5-8 years ]
    Major complications include surgery for prolapse repair, re-hospitalization or functional complications. Minor complications include all adverse events that are not major complications. Mesh-specific complications include vaginal pain, vaginal erosions, displacement and retraction of the mesh.

  3. The PGI-I questionnaire [ Time Frame: 5-8 years ]
  4. The PFDI questionnaire [ Time Frame: 5-8 years ]
  5. The PFIQ questionnaire [ Time Frame: 5-8 years ]
  6. The PISQ-12 questionnaire [ Time Frame: 5-8 years ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient included in, randomized and analysed in the PROCURE study (NCT00153257)

Exclusion Criteria:

  • 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
  • Patient not included in the PROCURE study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255994


Locations
France
Clinique Champeau
Béziers, France, 34500
APHP - Hôpital Antoine Beclere
Clamart Cedex, France, 92141
CHU de Clermont Ferrand - Hôpital Estaing
Clermont Ferrand, France, 63003
APHP - Hôpital Beaujon
Clichy, France, 92110
CH d'Issoire - Centre Hospitalier Paul Ardier
Issoire, France, 63503
CH de la Rochelle
La Rochelle Cedex, France, 17019
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, France, 28630
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin Bicêtre Cedex, France, 94275
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
CH d'Orange - Hôpital Louis Giorgi
Orange, France, 84106
Clinique Mutualiste La Sagesse
Rennes, France, 35000
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Renaud de Tayrac, MD, PhD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02255994     History of Changes
Other Study ID Numbers: LOCAL/2013/RdeT-01
2013-A01705-40 ( Other Identifier: RCB number )
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Prolapse
Cystocele
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse