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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01637441
Other study ID # 2011_24
Secondary ID 2011-A01282-39
Status Completed
Phase N/A
First received July 6, 2012
Last updated November 3, 2015
Start date September 2012
Est. completion date November 2015

Study information

Verified date November 2015
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 262
Est. completion date November 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France Sébatien BLANC Annecy
France Hôpital Antoine Béclère Clamart
France CHU Estaing Clermont Ferrand
France GCS Flandre Maritime Grande Synthe
France CH La Rochelle Service de Gynécologie Obstétrique La Rochelle
France Hôpital BICETRE / Service de Gynécologie Obstétrique Le Kremlin Bicêtre
France CHRU de Lille - Service de Gynécologie médico chirurgicale Lille
France CHU de Nîmes Nîmes
France Groupe Hospitalier Diaconesses Croix St-Simon Paris
France CHI Poissy-St-Germain / Service de gynécologie Poissy
France CHU de Poitiers Poitiers
France Hôpital de Hautepierre Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months Yes
Secondary Specific complications Comparison for the specific complications of sub-vesical mesh according to the route :
Symptomatic erosions, shrinkages, infections,
Serious Adverse event
12 months Yes
Secondary 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
12 months Yes
Secondary 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
12 months No
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