Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

Genital Prolapse Clinical Trial

Official title:

Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00784602
• Other study ID #: 2008-242
• Status: Terminated
• Phase: N/A
• First received: November 3, 2008
• Last updated: December 30, 2017
• Start date: October 29, 2008
• Est. completion date: August 29, 2016

Study information

• Verified date: December 2017
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 301
• Est. completion date: August 29, 2016
• Est. primary completion date: August 29, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Female

• Pelvic Organ Prolapse

• Able to provide informed consent

• Able to complete study assessments, per clinician judgment

Exclusion Criteria:

• Age < 21 years

• Currently pregnant or < 6 months post-partum

Related Conditions & MeSH terms

• Genital Prolapse
• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Melissa Fischer, MD	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires		Ongoing