Dilators for Dyspareunia Prevention (DDS)

MedStar Health

Status and phase: Completed; Phase 4

Conditions: Post-operative Dyspareunia

Treatments: Behavioral: Dilator use

Study type: Interventional

Funder types: Other

Identifiers

NCT01299363

2010-229

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

No dilator use

No Intervention group

Dilator use

Active Comparator group

Description:

Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8

Treatment:

Behavioral: Dilator use