Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153231
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

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 or disease Intervention/treatment Phase
Vaginal Prolapse Device: IVS Procedure: Sacrospinofixation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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.
Study Start Date : March 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : May 2007

Arm Intervention/treatment
Experimental: Infracoccygeal sacropexy
Intervention: IVS
Device: IVS
Infracoccygeal sacropexy

Active Comparator: Sacrospinofixation
Intervention: Sacrospinofixation
Procedure: Sacrospinofixation

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

Secondary Outcome Measures :
  1. - Peri-operative morbidity
  2. - Patient satisfaction
  3. - Quality of life
  4. - Post-operative sexuality
  5. - Anatomical cure rate on vaginal vault support

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153231

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

Responsible Party: Centre Hospitalier Universitaire de Nīmes Identifier: NCT00153231     History of Changes
Other Study ID Numbers: SPIC
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Uterine Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female