Back to resultsDilators for Dyspareunia Prevention (DDS)
Primary Purpose
Post-operative Dyspareunia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dilator use
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Dyspareunia focused on measuring Prolapse, Pain with intercourse, Dyspareunia, Post operative pain
Eligibility Criteria
Inclusion Criteria:
- Women who undergo pelvic organ prolapse surgery with a posterior repair
- 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:
- Significant baseline dyspareunia
- Pregnancy by self-report or positive pregnancy test
- Prior pelvic radiation therapy
- Active pelvic infection, herpes, candidiasis
Sites / Locations
- Washington Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No dilator use
Dilator use
Arm Description
Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8
Outcomes
Primary Outcome Measures
To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy).
Secondary Outcome Measures
Sexual function
Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12
Physical exam
Change in vaginal caliber and POP Q measurements 3 and 6 months after vaginal reconstructive surgery and its relation to sexual function scores and rates of dyspareunia.
Full Information
NCT ID
NCT01299363
First Posted
February 14, 2011
Last Updated
April 7, 2015
Sponsor
Medstar Health Research Institute
Collaborators
American College of Obstetricians and Gynecologists
1. Study Identification
Unique Protocol Identification Number
NCT01299363
Brief Title
Dilators for Dyspareunia Prevention
Acronym
DDS
Official Title
Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
American College of Obstetricians and Gynecologists
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Dyspareunia
Keywords
Prolapse, Pain with intercourse, Dyspareunia, Post operative pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No dilator use
Arm Type
No Intervention
Arm Title
Dilator use
Arm Type
Active Comparator
Arm Description
Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8
Intervention Type
Behavioral
Intervention Name(s)
Dilator use
Intervention Description
Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8
Primary Outcome Measure Information:
Title
To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Sexual function
Description
Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12
Time Frame
6 month
Title
Physical exam
Description
Change in vaginal caliber and POP Q measurements 3 and 6 months after vaginal reconstructive surgery and its relation to sexual function scores and rates of dyspareunia.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who undergo pelvic organ prolapse surgery with a posterior repair
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:
Significant baseline dyspareunia
Pregnancy by self-report or positive pregnancy test
Prior pelvic radiation therapy
Active pelvic infection, herpes, candidiasis
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23812462
Citation
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.
Results Reference
derived
Learn more about this trial
Dilators for Dyspareunia Prevention
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