Pelvic Organ ProlapsePhase 3NCT05493735
Lidocaine for Pessary Check Pain Reduction
A Phase 3 study testing Lidocaine Hcl 2% Jelly in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by University of South Florida at 1 site in United States.
Trial summary
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- Lidocaine Hcl 2% Jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 30 Jun 2023
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Presenting for routine pessary management for prolapse, stress urinary incontinence, or both with a pessary in place
- able to provide written informed consent
- able to complete the visual analog scale
Who cannot join
- Women less than 18 years of age.
- Patients who speak neither English nor Spanish
- Pregnancy
- Medical contraindication to lidocaine
- Planned change in pessary size or type
- Patients who remove and reinsert their pessary at home
Trial locations and contacts
1 site in 1 country.
United States1 site
USF Health Outpatient Urogynecology Clinics
Tampa, Florida, 33606
About this study
Official title: Lidocaine for Pessary Removal and Reinsertion Pain Reduction
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
Read the detailed description
The purpose of the study is to investigate the effects of lidocaine jelly on patient pain at the time of office pessary removal and reinsertion. All patients presenting to the University of South Florida Urogynecology clinic for a pessary maintenance appointment or "pessary check" will be screened as potential study participants. After being informed of risks and benefits of participation, informed consent will be obtained. Patients will be randomized into two groups: the control group or experimental group. The patient will complete a brief questionnaire and pain assessment using a Visual Analog Scale (VAS).
Patients will be blinded. The investigators will be unblinded. The investigators will apply the jelly (lidocaine vs lubricating). The participant will have an equal chance of being in the control arm or experimental arm. After 5 minutes, the investigator will assess the patient's genital hiatus with valsalva and proceed with pessary removal per the investigator's routine. The patient will complete another VAS to indicate pain level after pessary removal. The investigator will perform a speculum exam per routine and then reinsert the pessary. The patient will complete a final VAS to indicate level of pain after pessary reinsertion along with a brief final questionnaire.
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence
- Being tested
- Lidocaine Hcl 2% Jelly, Placebo Jelly
- Keywords
- Pessary, Lidocaine, Pain Reduction, Pessary Check, Pessary Removal, Pessary Reinsertion, Lubricating Jelly
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hcl 2% JellyDrug
Also called Lidocaine Jelly
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Placebo JellyDrug
Also called Lubricating Gel, Vaginal Lubricant
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal. Receives: Drug: Placebo Jelly |
| Experimental | Experimental | Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal. Receives: Drug: Lidocaine Hcl 2% Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient's pain using the visual analog scale (VAS) after pessary removal
Self-reported pain level at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Measured: 0 and 5 minutes
Secondary outcomes (2)
Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion
Self-reported pain level at time of pessary reinsertion controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Measured: 0 and 10 minutes
Genital Hiatus with Valsalva
Genital hiatus measurement in centimeters prior to removal of the pessary
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start8 Sep 2022
- Primary completion23 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Araba A Jackson, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493735
- Sponsor's protocol ID
- Pro004522
- Status last verified
- Dec 2023
- First submitted
- 15 Jul 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donnelly 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 21575953Taege 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 28594757Keskin 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 22417905Ozel BZ, Sun V, Pahwa A, Nelken R, Dancz CE. Randomized controlled trial of 2% lidocaine gel versus water-based lubricant for multi-channel urodynamics. Int Urogynecol J. 2018 Sep;29(9):1297-1302. doi: 10.1007/s00192-018-3576-8. Epub 2018 Feb 17.
PubMed 29455237
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine for Pessary Removal and Reinsertion Pain Reduction
- ClinicalTrials.gov ID
- NCT05493735
- Acronym / sponsor ID
- Pro004522
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence
- Keywords
- Pessary, Lidocaine, Pain Reduction, Pessary Check, Pessary Removal, Pessary Reinsertion, Lubricating Jelly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Aug 2022 (actual)
- 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.
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
Detailed description
The purpose of the study is to investigate the effects of lidocaine jelly on patient pain at the time of office pessary removal and reinsertion. All patients presenting to the University of South Florida Urogynecology clinic for a pessary maintenance appointment or "pessary check" will be screened as potential study participants. After being informed of risks and benefits of participation, informed consent will be obtained. Patients will be randomized into two groups: the control group or experimental group. The patient will complete a brief questionnaire and pain assessment using a Visual Analog Scale (VAS).
Patients will be blinded. The investigators will be unblinded. The investigators will apply the jelly (lidocaine vs lubricating). The participant will have an equal chance of being in the control arm or experimental arm. After 5 minutes, the investigator will assess the patient's genital hiatus with valsalva and proceed with pessary removal per the investigator's routine. The patient will complete another VAS to indicate pain level after pessary removal. The investigator will perform a speculum exam per routine and then reinsert the pessary. The patient will complete a final VAS to indicate level of pain after pessary reinsertion along with a brief final questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo JellyLubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal. |
| Experimental | Experimental | Drug: Lidocaine Hcl 2% JellyLidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 years or older
- Presenting for routine pessary management for prolapse, stress urinary incontinence, or both with a pessary in place
- able to provide written informed consent
- able to complete the visual analog scale
Key exclusion criteria (6 listed)
- Women less than 18 years of age.
- Patients who speak neither English nor Spanish
- Pregnancy
- Medical contraindication to lidocaine
- Planned change in pessary size or type
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 Hcl 2% JellyAlso: Lidocaine JellyParticipants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel. | Drug | Experimental |
| Placebo JellyAlso: Lubricating Gel, Vaginal LubricantParticipants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly. | Drug | Control |
Primary outcome
Change in patient's pain using the visual analog scale (VAS) after pessary removal
Time frame: 0 and 5 minutes
Self-reported pain level at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
2 secondary outcomes
Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion
Time frame: 0 and 10 minutes
Genital Hiatus with Valsalva
Time frame: 0 minutes
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 14 Dec 2023.
- 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 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.
- 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 29455237Ozel BZ, Sun V, Pahwa A, Nelken R, Dancz CE. Randomized controlled trial of 2% lidocaine gel versus water-based lubricant for multi-channel urodynamics. Int Urogynecol J. 2018 Sep;29(9):1297-1302. doi: 10.1007/s00192-018-3576-8. Epub 2018 Feb 17.
- Individual participant dataSharing planned: No
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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.
Araba A Jackson, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Hcl 2% Jelly in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by University of South Florida 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 4 inclusion and 6 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 14 Dec 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in patient's pain using the visual analog scale (VAS) after pessary removal (time frame: 0 and 5 minutes). 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 NCT05493735, which also lists 6 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 14 Dec 2023.