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	Phase IV

Further Study Details: 

Primary Outcomes: Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
Secondary Outcomes: - Peri-operative morbidity; - Patient satisfaction; - Quality of life; - Post-operative sexuality; - Anatomical cure rate on vaginal vault support
Expected Total Enrollment:  80

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00153231

Renaud de Tayrac, MD      0033603263232    renaud.detayrac@chu-nimes.fr

France
      Hôpital Carémeau, Nimes,  30000,  France; Recruiting

Study chairs or principal investigators

Renaud de Tayrac, MD,  Principal Investigator,  Hôpital Carémeau, Nimes, France   

Study ID Numbers:  SPIC
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153231
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13