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Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

This study is currently recruiting participants.
Verified July 2011 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01387685
First received: June 29, 2011
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 80
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

Ages Eligible for Study:   18 Years to 95 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387685

Contacts
Contact: Menahem Neuman, MD 0546444033 mneuman@netvision.net.il

Locations
Israel
Department of Obstetrics and Gynecology, Western Galilee Hospital Recruiting
Nahariya, Israel
Sub-Investigator: Jacob Bornstein, MD, MPA            
Sub-Investigator: Vladimir Sosnovsky, MD            
Sub-Investigator: Rene Tendler, MD            
Sub-Investigator: Mohamed Kais, MD            
Dr Neuman clinic Recruiting
Tel Aviv, Israel
Contact: Menahem Neuman, MD            
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

No publications provided

Responsible Party: Dr. Menahem Neuman, Western Galilee Hospital and vaious clinics
ClinicalTrials.gov Identifier: NCT01387685     History of Changes
Other Study ID Numbers: 920090042
Study First Received: June 29, 2011
Last Updated: July 25, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013