Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone

University Of Perugia

Status and phase: Completed; Phase 3

Conditions: Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Procedure: POP repair; Procedure: POP repair plus mini-sling

Study type: Interventional

Funder types: Other

Identifiers

NCT01384084

UPerugia-1

Details and patient eligibility

About

The investigators have performed colposacropexy in women with uterovaginal prolapse for many years with satisfactory results.

This study was designed to compare whether, in the treatment of patients with uro-genital prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure such as mini-sling is associated with a reduction of post-operative urinary incontinence (correction of pre-existent urinary incontinence and prevention of masked urinary incontinence).

Enrollment: 50 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients affected by III-IV grade urogenital urogenital prolapsed and urinary incontinence
• Candidates for pelvic organ prolapsed repair using sacropexy
• Prospectively randomized, using a predetermined computer-generated randomization code (4 blocks), to sacropexy plus anti-incontinence procedure (mini-sling) or sacropexy alone

Exclusion criteria

• fertile patients
• contraindication to major surgery
• uterine cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

POP repair plus mini-sling

Experimental group

Description:

Patients affected by urogenital prolapse and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy plus anti-incontinence procedure (mini-sling).

Treatment:

Procedure: POP repair plus mini-sling

pelvic organ prolapse repair

Active Comparator group

Description:

Patients affected by urogenital prolapsed and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy alone.

Treatment:

Procedure: POP repair