NCT01246271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
Last Updated

November 23, 2010

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

November 19, 2010

Last Update Submit

November 22, 2010

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence cure rate according ICIQ-UIsf

    3 month after surgery

Secondary Outcomes (1)

  • morbidity and complication

    3 month after surgery

Study Arms (2)

Sub urethral sling

sus with anterior vainal wall repair

Eligibility Criteria

Age27 Years - 78 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

woman with stress urinary incontinence

You may qualify if:

  • Patients must be female
  • Subjective evidence of stress predominant symptoms on symptom specific questionnaire
  • Stress incontinence on urodynamics
  • Patients must be capable of filling in the symptom diary
  • Prolapse beyond the introitus

You may not qualify if:

  • Patients who are medically unfit to undergo surgical intervention.
  • Patients who have undergone previous continence surgery
  • Patients with voiding dysfunction
  • Patients with recurrent urinary tract infection
  • Patients who are not sure that their family is complete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department Imam Reza Hospital

Tabriz, Iran

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 23, 2010

Study Start

February 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 23, 2010

Record last verified: 2008-01

Locations

IR(1)