SIS Graft and Traditional Repair in Vaginal Wall Prolapse

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Biologic Graft (SIS); Procedure: Traditional correction of anterior vaginal wall prolapse

Study type: Interventional

Funder types: Other

Identifiers

NCT00827528

SISAPI 01

Details and patient eligibility

About

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.

Full description

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications

Enrollment: 56 patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• anterior vaginal wall prolapse with poin Ba at least at +1;
• pre and postmenopausal patients

Exclusion criteria

• patients without surgical indication;
• infection;
• coagulopathy;
• gynecologic cancer;
• liver or kidney active diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

SIS graft

Experimental group

Description:

this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.

Treatment:

Procedure: Biologic Graft (SIS)

2

Active Comparator group

Description:

this group will use a traditional repair on correction of anterior vaginal wall prolapse.

Treatment:

Procedure: Traditional correction of anterior vaginal wall prolapse