Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00697489
• Other study ID #: 01/2008
• Status: Withdrawn
• Phase: Phase 4
• First received: June 12, 2008
• Last updated: April 5, 2013
• Start date: June 2008

Study information

• Verified date: April 2013
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence, Stress

Intervention

Procedure:
• correction of POP plus preventive continence procedure

• POP surgery followed by eventual incontinence procedure

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy (cure rate)		12 months	No
Secondary	intra-operative complication rate		one day	Yes
Secondary	postoperative complications rate		12 months	Yes
Secondary	sexual function		12 months	No
Secondary	quality of life		12 months	No
Secondary	Failure rate		12 months	No
Secondary	Recurrence rate		12 months	No