Pelvic Organ Prolapse, Urinary Incontinence
Conditions
Keywords
pelvic organ prolapse, urinary incontinence, sacropexy, sling
Brief summary
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).
Interventions
PROCEDUREPOP repair plus mini-sling
For POP, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. A mini sling system will be used, placing a urethral low-tension tape anchored to the obturator muscles bilaterally at the level of tendinous arc. This mini-sling is a polypropylene monofilament mesh.
PROCEDUREPOP repair
For POP repair, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. The peritoneum is closed over the meshes.
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary incontinence | 12 months | long-term relief of symptoms with anatomic correction of prolapse and subjective/objective correction of urinary incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peri and post-operative complications | 1 month | Operative time and morbidity according to Clavien-Dindo classification, post-operative complications, length of hospital stay. |
Countries
Italy
Outcome results
None listed