Vaginal InfectionNCT01843166
Vaginal Estrogen With Pessary Treatment
A study testing Premarin vaginal cream in people with Vaginal Infection and Urinary Tract Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Vaginal Infection, Urinary Tract Infection, Quality of Life
- What is being tested?
- Premarin vaginal cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2016
- Phase
- Interventional
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.
Who cannot join
- have a contraindication to the use of estrogen cream or products
- have any allergy to the use of estrogen cream or products
- have a past medical or family history of breast cancer
- have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
- have previously used Premarin vaginal cream
- are currently using oral estrogen
- are not competent to consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5W9
About this study
Official title: Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.
Read the detailed description
This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered management with a pessary and participation in the study
Patients who agree to participate in the study will be given a consent form
Patients in the study and thus those who have opted for pessary use will be randomized between two groups:
- Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
- Control group - will utilize pessary with an inactive placebo cream
Both the patient and the investigators will be blinded to patient treatment.
If a patient has expressed willingness to participate in the study over the phone, the research assistant will issue a study number to the patient and pick up the corresponding cream from the LHSC pharmacy to give to the patient at their next clinic visit. The cream will be provided to the patient once they have read the letter of information and signed the consent form.
For follow-up visits, the research assistant will monitor appointment bookings to ensure that the cream is ready in the clinic when the patient has their next follow-up visit.
Patients of both groups will be fitted with a pessary. Pessary fitting will be individualized due to differences in pelvic size and shape and degree of prolapse. Patients may return to the clinic for subsequent fittings until a successful fit has been achieved. An unsuccessful fitting is defined as discontinued pessary use due to discomfort or expulsion.
Patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks after the successful fitting.
To determine patient satisfaction and complications, patients will complete a compilation of validated questionnaires assessing urinary symptoms, sexual function and quality of life at each follow-up.
At each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and infections.
- Conditions
- Vaginal Infection, Urinary Tract Infection, Quality of Life
- Being tested
- Premarin vaginal cream, Placebo cream
- Keywords
- Pessary, Patient Satisfaction, Estrogen Cream
- Medical subject headings
- Vaginitis, Urinary Tract Infections, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premarin vaginal creamDrug
2g at bedtime twice weekly
Placebo creamDrug
2g at bedtime twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly. Receives: Drug: Premarin vaginal cream |
| Control group | Placebo comparator | These patients will utilize a pessary with an inactive placebo cream. Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal infections
Vaginal swabs at each follow up visit will be used to detect presence or absence of vaginal infection. A total count of vaginal infections per patient will be compared between groups.
Measured: 60 weeks
Secondary outcomes (2)
Frequency of urinary tract infection
Urine samples at each follow-up visit will be used to detect the presence or absence of a urinary tract infection.
Measured: 60 weeks
Quality of life
Patients will complete validated questionnaires to assess quality of life with respect to urinary, bowel, and sexual function.
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2016
- Study completionDec 2016
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 Vaginal InfectionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario, University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Queena Chou, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843166
- Sponsor's protocol ID
- 102186
- Other IDs
- 18798
- Status last verified
- Nov 2018
- First submitted
- 8 Jul 2012
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
PubMed 33207004
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01843166
- Acronym / sponsor ID
- 102186
- Conditions
- Vaginal Infection, Urinary Tract Infection, Quality of Life
- Keywords
- Pessary, Patient Satisfaction, Estrogen Cream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario, University of Western Ontario, Canada
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Apr 2013 (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.
Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.
Detailed description
This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered management with a pessary and participation in the study
Patients who agree to participate in the study will be given a consent form
Patients in the study and thus those who have opted for pessary use will be randomized between two groups:
- Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
- Control group - will utilize pessary with an inactive placebo cream
Both the patient and the investigators will be blinded to patient treatment.
If a patient has expressed willingness to participate in the study over the phone, the research assistant will issue a study number to the patient and pick up the corresponding cream from the LHSC pharmacy to give to the patient at their next clinic visit. The cream will be provided to the patient once they have read the letter of information and signed the consent form.
For follow-up visits, the research assistant will monitor appointment bookings to ensure that the cream is ready in the clinic when the patient has their next follow-up visit.
Patients of both groups will be fitted with a pessary. Pessary fitting will be individualized due to differences in pelvic size and shape and degree of prolapse. Patients may return to the clinic for subsequent fittings until a successful fit has been achieved. An unsuccessful fitting is defined as discontinued pessary use due to discomfort or expulsion.
Patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks after the successful fitting.
To determine patient satisfaction and complications, patients will complete a compilation of validated questionnaires assessing urinary symptoms, sexual function and quality of life at each follow-up.
At each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: Premarin vaginal creamThese patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly. |
| Control group | Placebo comparator | Drug: Placebo creamThese patients will utilize a pessary with an inactive placebo cream. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.
Key exclusion criteria (7 listed)
- have a contraindication to the use of estrogen cream or products
- have any allergy to the use of estrogen cream or products
- have a past medical or family history of breast cancer
- have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
- have previously used Premarin vaginal cream
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 |
|---|---|---|
| Premarin vaginal cream2g at bedtime twice weekly | Drug | Treatment group |
| Placebo cream2g at bedtime twice weekly | Drug | Control group |
Primary outcome
Vaginal infections
Time frame: 60 weeks
Vaginal swabs at each follow up visit will be used to detect presence or absence of vaginal infection. A total count of vaginal infections per patient will be compared between groups.
2 secondary outcomes
Frequency of urinary tract infection
Time frame: 60 weeks
Quality of life
Time frame: 60 weeks
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 6 Nov 2018.
- Derived from this study: PubMed 33207004Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
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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.
Queena Chou, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premarin vaginal cream in people with Vaginal Infection and Urinary Tract Infection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 1 inclusion and 7 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 6 Nov 2018. 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 Canada. 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.
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?
Vaginal infections (time frame: 60 weeks). 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 NCT01843166, 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 6 Nov 2018.