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Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

This study has been completed.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes Identifier:
First received: September 8, 2005
Last updated: March 26, 2015
Last verified: March 2015

Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.

Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.

Condition Intervention Phase
Vaginal Prolapse Device: IVS Procedure: Sacrospinofixation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Early post-operative pain evaluated by a visual analogic pain the next day after the operation.

Secondary Outcome Measures:
  • - Peri-operative morbidity
  • - Patient satisfaction
  • - Quality of life
  • - Post-operative sexuality
  • - Anatomical cure rate on vaginal vault support

Enrollment: 49
Study Start Date: March 2003
Study Completion Date: May 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infracoccygeal sacropexy
Intervention: IVS
Device: IVS
Infracoccygeal sacropexy
Active Comparator: Sacrospinofixation
Intervention: Sacrospinofixation
Procedure: Sacrospinofixation


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age more than 18
  • Vaginal vault prolapse of grade 2 or more (POP-Q system)
  • Symptomatic prolapse

Exclusion Criteria:

  • Patient unable to read French language
  • Cystocele without vaginal vault prolapse
  • Vaginal vault prolapse of grade 1
  • Associated rectal prolapse
  • Rectal inflammatory disease (Crohn, RCH).
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Please refer to this study by its identifier: NCT00153231

Hôpital Carémeau
Nimes, France, 30000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Principal Investigator: Renaud de Tayrac, MD Hôpital Carémeau, Nimes, France
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT00153231     History of Changes
Other Study ID Numbers: SPIC
Study First Received: September 8, 2005
Last Updated: March 26, 2015

Additional relevant MeSH terms:
Uterine Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female processed this record on September 21, 2017