Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2010-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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No dilator use
No interventions assigned to this group
Dilator use
Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8
Dilator use
Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8
Interventions
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Dilator use
Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Sexually active with heterosexual vaginal intercourse
* English speaking
* Available for 6 month follow up
* Able to complete study questionnaires
* Able to use dilators
Exclusion Criteria
* Pregnancy by self-report or positive pregnancy test
* Prior pelvic radiation therapy
* Active pelvic infection, herpes, candidiasis
18 Years
FEMALE
No
Sponsors
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American College of Obstetricians and Gynecologists
OTHER
Medstar Health Research Institute
OTHER
Responsible Party
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Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
Countries
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References
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Antosh DD, Gutman RE, Park AJ, Sokol AI, Peterson JL, Kingsberg SA, Iglesia CB. Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jun;121(6):1273-1280. doi: 10.1097/AOG.0b013e3182932ce2.
Other Identifiers
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2010-229
Identifier Type: -
Identifier Source: org_study_id
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