NCT01299363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

February 14, 2011

Last Update Submit

April 7, 2015

Conditions

Post-operative Dyspareunia

Keywords

ProlapsePain with intercourseDyspareuniaPost operative pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sexual function

    6 month

  • Physical exam

    6 months

Study Arms (2)

No dilator use

NO INTERVENTION

Dilator use

ACTIVE COMPARATOR

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

Behavioral: Dilator use

Interventions

Dilator useBEHAVIORAL

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

Dilator use

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant baseline dyspareunia
  • Pregnancy by self-report or positive pregnancy test
  • Prior pelvic radiation therapy
  • Active pelvic infection, herpes, candidiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

  • 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.

    PMID: 23812462DERIVED

MeSH Terms

Conditions

ProlapseDyspareuniaPain, Postoperative

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 18, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

US(1)