Dilators for Dyspareunia Prevention

Post-operative Dyspareunia Clinical Trial

— DDS  

Official title:

Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299363
• Other study ID #: 2010-229
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: April 7, 2015
• Start date: September 2010
• Est. completion date: August 2013

Study information

• Verified date: April 2015
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyspareunia
• Post-operative Dyspareunia

Intervention

Behavioral:
• Dilator use
Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Research Institute	American College of Obstetricians and Gynecologists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 months	No
Secondary	Sexual function	Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12	6 month	No
Secondary	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.	6 months	No