Sub Urethral Sling With or With Out Anterior Repair

Urinary Incontinence Clinical Trial

Official title:

a Retrospective Cohort Recognize the Out Comes of SUS With or Without Anterior Vaginal Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246271
• Other study ID #: 89-234
• Secondary ID: 8948
• Status: Completed
• Phase: N/A
• First received: November 19, 2010
• Last updated: November 22, 2010
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2008
• Source: Tabriz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 27 Years to 78 Years

Eligibility

Inclusion Criteria:

1. Patients must be female

2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire

3. Stress incontinence on urodynamics

4. Patients must be capable of filling in the symptom diary

5. Prolapse beyond the introitus

Exclusion Criteria:

1. Patients who are medically unfit to undergo surgical intervention.

2. Patients who have undergone previous continence surgery

3. Patients with voiding dysfunction

4. Patients with recurrent urinary tract infection

5. Patients who are not sure that their family is complete

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Urinary Incontinence

Locations

Country	Name	City	State
Iran, Islamic Republic of	Urology department Imam Reza Hospital	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence cure rate according ICIQ-UIsf		3 month after surgery	Yes
Secondary	morbidity and complication		3 month after surgery	Yes