Clinical trial NCT00697489: Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse
Official title: Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Urinary incontinence
Mesh
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2008-06-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. At this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a POP repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages.

Based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with POP without urinary stress incontinence. Specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of POP will be compared.

Detailed description: Women with POP not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups A and B). Patients of group A will be treated with unique surgery (correction of POP plus preventive continence procedure), whereas in patients of group B POP will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored.

All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility criteria: Inclusion Criteria:

* Pelvic organ prolapse stage 2-3
* Absence of subjective urinary stress incontinence

Exclusion Criteria:

* pregnancy
* \<12 months postpartum
* systemic disease known to affect bladder function
* current chemotherapy or radiation therapy
* urethral diverticulum, augmentation cytoplasty, or artificial sphincter
* recent pelvic surgery
* patient age under 18 and over 80
* any previous pelvic surgery, diabetes mellitus and collagen disease

Primary outcomes:
measure: efficacy (cure rate)
timeFrame: 12 months
Secondary outcomes:
measure: intra-operative complication rate
timeFrame: one day
measure: postoperative complications rate
timeFrame: 12 months
measure: sexual function
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
measure: Failure rate
timeFrame: 12 months
measure: Recurrence rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Fulvio Zullo, MD
role: STUDY_CHAIR
References: