Dilators for Dyspareunia Prevention

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01299363

Acronym

DDS

Enrollment

Registered

2011-02-18

Start date

2010-09-30

Completion date

2013-08-31

Last updated

2015-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Dyspareunia

Keywords

Prolapse, Pain with intercourse, Dyspareunia, Post operative pain

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.

Interventions

BEHAVIORALDilator use

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame	Description
Sexual function	6 month	Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12
Physical exam	6 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026