NCT00376441

Brief Summary

Assess the outcomes of vaginal surgeries and its impact on sexual function and urinary symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

2.3 years

First QC Date

September 13, 2006

Last Update Submit

August 19, 2011

Conditions

Keywords

vaginalincontinencesexual function

Interventions

patients undergoing vaginal surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women at least 18 years of age having urinary incontinence or pelvic organ prolapse.

You may qualify if:

  • Women at least 18 years of age
  • Having urinary incontinence or pelvic organ prolapse
  • Capable of giving informed consent
  • Capable and willing to follow all study related procedures

You may not qualify if:

  • Reported history of urethral obstruction (not secondary to prolapse), stricture, bladder calculi or bladder tumor in the last 2 years.
  • Pregnant as confirmed by urine pregnancy test or plans to become pregnant during the study period.
  • Breast feeding
  • Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function
  • Cannot independently comprehend and complete the questionnaires.
  • The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (5)

  • Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.

    PMID: 16399154BACKGROUND
  • Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537.

    PMID: 10022110BACKGROUND
  • Pauls RN, Segal JL, Silva WA, Kleeman SD, Karram MM. Sexual function in patients presenting to a urogynecology practice. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Nov;17(6):576-80. doi: 10.1007/s00192-006-0070-5. Epub 2006 Jun 8.

    PMID: 16767528BACKGROUND
  • Weber AM, Walters MD, Schover LR, Mitchinson A. Sexual function in women with uterovaginal prolapse and urinary incontinence. Obstet Gynecol. 1995 Apr;85(4):483-7. doi: 10.1016/0029-7844(94)00434-F.

    PMID: 7898820BACKGROUND
  • LeCroy C. Urinary incontinence occurring during intercourse: effect on sexual function in women. Urol Nurs. 2006 Feb;26(1):53-6. No abstract available.

    PMID: 16562386BACKGROUND

MeSH Terms

Conditions

Urinary IncontinencePelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProlapsePathological Conditions, Anatomical

Study Officials

  • Kenneth Peters, M.D.

    Corewell Health East

    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

September 13, 2006

First Posted

September 14, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations