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Prosthetic Pelvic Organ Prolapse Repair (PROSPERE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01637441
First received: July 6, 2012
Last updated: October 20, 2014
Last verified: October 2014

July 6, 2012
October 20, 2014
September 2012
April 2015   (final data collection date for primary outcome measure)
Morbidity (Dindo Classification) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.
Morbidity (Dindo Classification) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacroprexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.
Complete list of historical versions of study NCT01637441 on ClinicalTrials.gov Archive Site
  • Specific complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Comparison for the specific complications of sub-vesical mesh according to the route :

    • Symptomatic erosions, shrinkages, infections,
    • Serious Adverse event
  • Medium-term tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Comparison of both techniques for the medium-term tolerance:

    • Sexual: sexual quality of life, de novo dyspareunia;
    • Urinary: urinary quality of life, urinary functional signs, urgenturia, leakage
    • Post-operative chronic pelvic pains
  • Clinical Efficiency [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Comparison of both techniques for the medium-term (1 year follow-up)clinical efficiency:

    • rate of anatomical recurrences at one year,
    • functional Symptoms of prolapse, general quality of life
Same as current
Not Provided
Not Provided
 
Prosthetic Pelvic Organ Prolapse Repair
Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.

It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cystocele
  • Procedure: laparoscopic sacropexy
    under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.
    Other Name: laparoscopic surgery
  • Procedure: vaginal mesh
    after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.
    Other Name: medical vaginal device
  • Experimental: laparoscopic sacropexy
    under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.
    Intervention: Procedure: laparoscopic sacropexy
  • Experimental: vaginal mesh
    after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.
    Intervention: Procedure: vaginal mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
262
October 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse.
  • Patient must have provided written informed consent form prior to enrolment
  • Patient must be insured

Exclusion Criteria:

  • Previous of surgery for prolapse
  • Unfavourable conditions to one or other of the 2 evaluated procedure
  • Pelvic malignancy in the course of evolution
  • Contraindication to the use of mesh
  • Women not reading French
  • Patients haven't have a social insurance
  • Pregnancy or desire for future pregnancy
  • To be under guardianship or deprived of liberty
  • Simultaneous participation in another biomedical research
Female
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01637441
2011_24, 2011-A01282-39
Yes
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Jean-Philippe LUCOT, MD CHRU de LILLE
University Hospital, Lille
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP