PainPhase 2NCT02380742
Topical Anesthetic Use In Pessary Management
A Phase 2 study testing lidocaine-prilocaine cream in people with Pain, run by Loyola University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- lidocaine-prilocaine cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
- Read and speak the English language
Who cannot join
- Non-English speaking
- Allergy or contraindication to topical anesthetic
- Participation/randomization in the study at a previous visit
- Currently pregnant or lactating or planning a pregnancy within the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Topical Anesthetic Use In Pessary Management: A Randomized Double Blinded Placebo Controlled Trial
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
Read the detailed description
Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream.
Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.
- Conditions
- Pain
- Being tested
- lidocaine-prilocaine cream, Placebo cream
- Keywords
- Pessary, Pain, EMLA, lidocaine, prilocaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-prilocaine creamDrug
Also called 5% EMLA cream
The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
Placebo creamDrug
The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
| Study group | Role | What they receive |
|---|---|---|
| lidocaine-prilocaine | Experimental | 4 mL of lidocaine-prilocaine cream Receives: Drug: lidocaine-prilocaine cream |
| Placebo | Placebo comparator | 4 mL of placebo cream Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Measured: Removal of Pessary
Secondary outcomes (3)
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Measured: Removal of Pessary
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Measured: Removal of Pessary
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Measured: Insertion of Pessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Brincat, Loyola University
- Investigators
- Cynthia Brincat, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380742
- Sponsor's protocol ID
- 206945
- Status last verified
- Jan 2017
- First submitted
- 26 Feb 2015
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.
PubMed 15339758Melville JL, Katon W, Delaney K, Newton K. Urinary incontinence in US women: a population-based study. Arch Intern Med. 2005 Mar 14;165(5):537-42. doi: 10.1001/archinte.165.5.537.
PubMed 15767530Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
PubMed 9083302Donnelly MJ, Powell-Morgan S, Olsen AL, Nygaard IE. Vaginal pessaries for the management of stress and mixed urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Sep-Oct;15(5):302-7. doi: 10.1007/s00192-004-1163-7. Epub 2004 Aug 5.
PubMed 15300365Nguyen JN, Jones CR. Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use. J Wound Ostomy Continence Nurs. 2005 Jul-Aug;32(4):255-61; quiz 262-3. doi: 10.1097/00152192-200507000-00010.
PubMed 16030465Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14.
PubMed 21575953Keskin AE, Onaran Y, Duvan IC, Simavli S, Kafali H. Topical anesthetic (lidocaine-prilocaine) cream application before speculum examination in postmenopausal women. J Minim Invasive Gynecol. 2012 May-Jun;19(3):350-5. doi: 10.1016/j.jmig.2012.01.005. Epub 2012 Mar 13.
PubMed 22417905Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. doi: 10.1097/00006254-200203000-00022.
PubMed 11889416Wahlgren CF, Lillieborg S. Split-skin grafting with lidocaine-prilocaine cream: A meta-analysis of efficacy and safety in geriatric versus nongeriatric patients. Plast Reconstr Surg. 2001 Mar;107(3):750-6. doi: 10.1097/00006534-200103000-00015.
PubMed 11304601Taege SK, Adams W, Mueller ER, Brubaker L, Fitzgerald CM, Brincat C. Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):190-197. doi: 10.1097/AOG.0000000000002098.
PubMed 28594757
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthetic Use In Pessary Management: A Randomized Double Blinded Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02380742
- Acronym / sponsor ID
- 206945
- Conditions
- Pain
- Keywords
- Pessary, Pain, EMLA, lidocaine, prilocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
Detailed description
Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream.
Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine-prilocaine | Experimental | Drug: lidocaine-prilocaine cream4 mL of lidocaine-prilocaine cream |
| Placebo | Placebo comparator | Drug: Placebo cream4 mL of placebo cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
- Read and speak the English language
Key exclusion criteria (4 listed)
- Non-English speaking
- Allergy or contraindication to topical anesthetic
- Participation/randomization in the study at a previous visit
- Currently pregnant or lactating or planning a pregnancy within the next 6 months
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 |
|---|---|---|
| lidocaine-prilocaine creamAlso: 5% EMLA creamThe patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point | Drug | lidocaine-prilocaine |
| Placebo creamThe patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point | Drug | Placebo |
Primary outcome
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
Time frame: Removal of Pessary
Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
3 secondary outcomes
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
Time frame: Removal of Pessary
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
Time frame: Removal of Pessary
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
Time frame: Insertion of Pessary
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15339758Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.
- Background: PubMed 15767530Melville JL, Katon W, Delaney K, Newton K. Urinary incontinence in US women: a population-based study. Arch Intern Med. 2005 Mar 14;165(5):537-42. doi: 10.1001/archinte.165.5.537.
- Background: PubMed 9083302Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
- Background: PubMed 15300365Donnelly MJ, Powell-Morgan S, Olsen AL, Nygaard IE. Vaginal pessaries for the management of stress and mixed urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Sep-Oct;15(5):302-7. doi: 10.1007/s00192-004-1163-7. Epub 2004 Aug 5.
- Background: PubMed 16030465Nguyen JN, Jones CR. Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use. J Wound Ostomy Continence Nurs. 2005 Jul-Aug;32(4):255-61; quiz 262-3. doi: 10.1097/00152192-200507000-00010.
- Background: PubMed 21575953Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14.
- Background: PubMed 22417905Keskin AE, Onaran Y, Duvan IC, Simavli S, Kafali H. Topical anesthetic (lidocaine-prilocaine) cream application before speculum examination in postmenopausal women. J Minim Invasive Gynecol. 2012 May-Jun;19(3):350-5. doi: 10.1016/j.jmig.2012.01.005. Epub 2012 Mar 13.
- Background: PubMed 11889416Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. doi: 10.1097/00006254-200203000-00022.
- Background: PubMed 11304601Wahlgren CF, Lillieborg S. Split-skin grafting with lidocaine-prilocaine cream: A meta-analysis of efficacy and safety in geriatric versus nongeriatric patients. Plast Reconstr Surg. 2001 Mar;107(3):750-6. doi: 10.1097/00006534-200103000-00015.
- Derived from this study: PubMed 28594757Taege SK, Adams W, Mueller ER, Brubaker L, Fitzgerald CM, Brincat C. Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):190-197. doi: 10.1097/AOG.0000000000002098.
- Individual participant dataSharing planned: Yes
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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.
Cynthia Brincat, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lidocaine-prilocaine cream in people with Pain, run by Loyola University 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 2 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 23 Feb 2017. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain (time frame: Removal of Pessary). 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 NCT02380742, which also lists 10 linked publications.
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 23 Feb 2017.