Anterior Prolift Versus Posterior Prolift for Pelvic Floor Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01392417
First received: June 29, 2011
Last updated: July 2, 2014
Last verified: July 2011
  Purpose

Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or Posterior prolift at least a year after the surgery.

The data from the charts and from telephone conversations with the patients will be entered to a database. Physical examination data will also be incorporated.


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:
  • Symptoms of pelvic floor prolapse [ Time Frame: One year after surgery ] [ Designated as safety issue: No ]
    We will question the women if they have a feeling of a mass protruding through the labia. Physical examination data will also be incorporated.


Enrollment: 140
Study Start Date: February 2009
Study Completion Date: June 2013
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 with pelvic floor prolapse who underwent surgery with Prolift

Criteria

Inclusion Criteria:

  • Women who underwent surgery by anterior Prolift or posterior Prolift for pelvic floor prolapse

Exclusion Criteria:

  • Women who did not have surgery by Prolift for pelvic floor prolapse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392417

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

No publications provided

Responsible Party: menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01392417     History of Changes
Other Study ID Numbers: 920090043
Study First Received: June 29, 2011
Last Updated: July 2, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014