A Phase 4 interventional study of correction of POP plus preventive continence procedure and POP surgery followed by eventual incontinence procedure in Pelvic Organ Prolapse, sponsored by University Magna Graecia. Withdrawn at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-04-08.
Sponsored by University Magna Graecia · Phase 4, Interventional, and Treatment
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.
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.
658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.
Browse Urinary Incontinence, Stress studies →University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
unique surgery
Procedure: correction of POP plus preventive continence procedure
Double surgery
Procedure: POP surgery followed by eventual incontinence procedure
efficacy (cure rate)
Time frame: 12 months
intra-operative complication rate
Time frame: one day
postoperative complications rate
Time frame: 12 months
sexual function
Time frame: 12 months
quality of life
Time frame: 12 months
Failure rate
Time frame: 12 months
Recurrence rate
Time frame: 12 months
This study is withdrawn, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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University Magna Graecia