Predictors of Post Operative Morbidity in Older Women With Pelvic Organ Prolapse

NCT01967446 | Completed

• 1 other identifier: 814338
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators hypothesize that functional status scores in elderly women undergoing surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have returned to baseline at 12 weeks post-operatively. The Investigators hypothesize that greater co-morbidity, frailty and worse functional status before surgery are associated with slower functional recovery, prolonged length of stay in a hospital or nursing care institution and greater post-operative complications following surgery for pelvic organ prolapse.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Predictors of Post Operative Morbidity in Older Women with Pelvic Organ Prolapse

  The primary outcome will be change in functional status scores at 12 weeks postoperatively as determined by Basic and Instrumental Activities of Daily Living as well as the Functional Health

  1 year

Secondary Outcomes (1)

• Predictors of Post Operative Morbidity in Older Women with Pelvic Organ Prolapse

  1year

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women will be recruited from 3 sites in the University of Pennsylvania Health System: 1) the Division of Urogynecology (OB/GYN) at Hospital of University of Pennsylvania (HUP) 2) the Division of Urogynecology (OB/GYN) at Pennsylvania Hospital (PAH) and 3) Division of Urology (Surgery) at Pennsylvania Hospital (PAH). Approximately 60 women age 60 or over undergo surgery for POP at HUP and 45 each in Urogynecology and Urology at PAH each year. This yields an eligible population of more than 150 women during the 1.25-year proposed recruitment period. We anticipate that interest in the study will be high because the study is investigating post-operative recovery and no invasive testing is planned.

You may qualify if:

• Women over age 60 undergoing either reconstructive or obliterative surgery (for Stage 2 or greater POP 2) English speaking

You may not qualify if:

• Women under the age of 60 will be excluded.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Joy A. Greer, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: October 22, 2013
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 10, 2014

Record last verified: 2012-08

Locations

US (1)