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Completed

NCT Number: NCT01637441

Prosthetic Pelvic Organ Prolapse 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.

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Key information

Conditions

Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sébatien BLANC, Annecy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic sacropexy

Procedure

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 names: laparoscopic surgery

vaginal mesh

Procedure

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 names: medical vaginal device

Primary outcomes

  1. Morbidity (Dindo Classification)

    Time frame: 12 months

    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 outcomes

  1. Specific complications

    Time frame: 12 months

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

    • Symptomatic erosions, shrinkages, infections,
    • Serious Adverse event

  2. Medium-term tolerance

    Time frame: 12 months

    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

  3. Clinical Efficiency

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

Acronym: PROSPERE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2012
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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