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Completed

NCT Number: NCT00153231

Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

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.

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Key information

Conditions

Vaginal Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Carémeau

Nîmes, 30000, France

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

IVS

Device

Infracoccygeal sacropexy

Sacrospinofixation

Procedure

Primary outcomes

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

Secondary outcomes

  1. - Peri-operative morbidity

  2. - Patient satisfaction

  3. - Quality of life

  4. - Post-operative sexuality

  5. - Anatomical cure rate on vaginal vault support

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Mar 27, 2015

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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