NCT00784602

Brief Summary

To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2016

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

7.8 years

First QC Date

November 3, 2008

Last Update Submit

December 30, 2017

Conditions

Genital Prolapse

Keywords

prolapsepelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

  • Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires

    Ongoing

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with genital prolapse.

You may qualify if:

  • Female
  • Pelvic Organ Prolapse
  • Able to provide informed consent
  • Able to complete study assessments, per clinician judgment

You may not qualify if:

  • Age \< 21 years
  • Currently pregnant or \< 6 months post-partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

ProlapsePelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Melissa Fischer, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 4, 2008

Study Start

October 29, 2008

Primary Completion

August 29, 2016

Study Completion

August 29, 2016

Last Updated

January 3, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)