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Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387685
First Posted: July 4, 2011
Last Update Posted: June 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Western Galilee Hospital-Nahariya
  Purpose
Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.

Condition
Pelvic Floor Prolapse

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Satisfaction with study outcome [ Time Frame: six to twelve months after surgery ]

Secondary Outcome Measures:
  • Side effects of the surgery: pain, vaginal erosion by tape, bleeding [ Time Frame: Within six to twelve months after study ]

Enrollment: 0
Study Start Date: February 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who underwent surgery for pelvic floor prolapse who underwent surgery by eithe surgeon-cut-mesh or by PIVS
Criteria

Inclusion Criteria:

  • Women who underwent surgery for pelvic floor prolapse

Exclusion Criteria:

  • Women who did not have surgery for pelvic floor prolapse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387685


Locations
Israel
Department of Obstetrics and Gynecology, Western Galilee Hospital
Nahariya, Israel
Dr Neuman clinic
Tel Aviv, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Responsible Party: Dr. Menahem Neuman, Western Galilee Hospital and vaious clinics
ClinicalTrials.gov Identifier: NCT01387685     History of Changes
Other Study ID Numbers: 920090042
First Submitted: June 29, 2011
First Posted: July 4, 2011
Last Update Posted: June 20, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical


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