Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT00153231
First received: September 8, 2005
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - Peri-operative morbidity [ Designated as safety issue: Yes ]
  • - Patient satisfaction [ Designated as safety issue: No ]
  • - Quality of life [ Designated as safety issue: No ]
  • - Post-operative sexuality [ Designated as safety issue: No ]
  • - Anatomical cure rate on vaginal vault support [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00153231

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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT00153231     History of Changes
Other Study ID Numbers: SPIC
Study First Received: September 8, 2005
Last Updated: March 3, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 14, 2014