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Prosthetic Pelvic Organ Prolapse Repair (PROSPERE)

Primary Purpose

Cystocele

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
laparoscopic sacropexy
vaginal mesh
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystocele focused on measuring bladder prolapse (cystocele), Pelvic organ prolapse repair, coelioscopic, prosthetic surgery, vaginal approach, Randomized study, laparoscopic sacropexy, vaginal mesh surgery, Stage II, Clavien Dindo

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sébatien BLANC
  • Hôpital Antoine Béclère
  • CHU Estaing
  • GCS Flandre Maritime
  • CH La Rochelle Service de Gynécologie Obstétrique
  • Hôpital BICETRE / Service de Gynécologie Obstétrique
  • CHRU de Lille - Service de Gynécologie médico chirurgicale
  • CHU de Nîmes
  • Groupe Hospitalier Diaconesses Croix St-Simon
  • CHI Poissy-St-Germain / Service de gynécologie
  • CHU de Poitiers
  • Hôpital de Hautepierre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

laparoscopic sacropexy

vaginal mesh

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Morbidity (Dindo Classification)
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.

Secondary Outcome Measures

Specific complications
Comparison for the specific complications of sub-vesical mesh according to the route : Symptomatic erosions, shrinkages, infections, Serious Adverse event
Medium-term tolerance
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
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

Full Information

First Posted
July 6, 2012
Last Updated
November 3, 2015
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01637441
Brief Title
Prosthetic Pelvic Organ Prolapse Repair
Acronym
PROSPERE
Official Title
Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystocele
Keywords
bladder prolapse (cystocele), Pelvic organ prolapse repair, coelioscopic, prosthetic surgery, vaginal approach, Randomized study, laparoscopic sacropexy, vaginal mesh surgery, Stage II, Clavien Dindo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic sacropexy
Arm Type
Experimental
Arm Description
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.
Arm Title
vaginal mesh
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
laparoscopic sacropexy
Other Intervention Name(s)
laparoscopic surgery
Intervention Description
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 Type
Procedure
Intervention Name(s)
vaginal mesh
Other Intervention Name(s)
medical vaginal device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morbidity (Dindo Classification)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Specific complications
Description
Comparison for the specific complications of sub-vesical mesh according to the route : Symptomatic erosions, shrinkages, infections, Serious Adverse event
Time Frame
12 months
Title
Medium-term tolerance
Description
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
Time Frame
12 months
Title
Clinical Efficiency
Description
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
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe LUCOT, MD
Organizational Affiliation
CHRU de LILLE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sébatien BLANC
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
CHU Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
GCS Flandre Maritime
City
Grande Synthe
ZIP/Postal Code
59760
Country
France
Facility Name
CH La Rochelle Service de Gynécologie Obstétrique
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Hôpital BICETRE / Service de Gynécologie Obstétrique
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU de Lille - Service de Gynécologie médico chirurgicale
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Groupe Hospitalier Diaconesses Croix St-Simon
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHI Poissy-St-Germain / Service de gynécologie
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

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Prosthetic Pelvic Organ Prolapse Repair

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