Post-operative DyspareuniaPhase 4DDSNCT01299363
Dilators for Dyspareunia Prevention
A Phase 4 study testing Dilator use in people with Post-operative Dyspareunia, run by Medstar Health Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-operative Dyspareunia
- What is being tested?
- Dilator use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant baseline dyspareunia
- Pregnancy by self-report or positive pregnancy test
- Prior pelvic radiation therapy
- Active pelvic infection, herpes, candidiasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial
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.
- Conditions
- Post-operative Dyspareunia
- Being tested
- Dilator use
- Keywords
- Prolapse, Pain with intercourse, Dyspareunia, Post operative pain
- Medical subject headings
- Prolapse, Dyspareunia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilator useBehavioural
Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8
| Study group | Role | What they receive |
|---|---|---|
| No dilator use | No intervention | Not described |
| Dilator use | Active comparator | Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8 Receives: Behavioral: Dilator use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (2)
Sexual function
Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12
Measured: 6 month
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative DyspareuniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299363
- Sponsor's protocol ID
- 2010-229
- Acronym
- DDS
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23812462
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01299363
- Acronym / sponsor ID
- DDS / 2010-229
- Conditions
- Post-operative Dyspareunia
- Keywords
- Prolapse, Pain with intercourse, Dyspareunia, Post operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No dilator use | No intervention | – |
| Dilator use | Active comparator | Behavioral: Dilator useWomen randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Significant baseline dyspareunia
- Pregnancy by self-report or positive pregnancy test
- Prior pelvic radiation therapy
- Active pelvic infection, herpes, candidiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dilator useWomen randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8 | Behavioural | Dilator use |
Primary outcome
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
2 secondary outcomes
Sexual function
Time frame: 6 month
Physical exam
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Derived from this study: PubMed 23812462Antosh 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dilator use in people with Post-operative Dyspareunia, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01299363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.