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Trial registered on ANZCTR


Registration number
ACTRN12618000416291
Ethics application status
Approved
Date submitted
4/03/2018
Date registered
21/03/2018
Date last updated
19/03/2019
Date data sharing statement initially provided
19/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Polyvinyl chloride ring pessary versus silicon irregular hexagon pessary for pelvic organ prolapse: a randomised trial comparing treatment success
Scientific title
Polyvinyl chloride ring pessary versus silicon irregular hexagon pessary for pelvic organ prolapse: a randomised trial comparing treatment success.
Secondary ID [1] 289415 0
None
Universal Trial Number (UTN)
U1111-1200-7897
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse (POP) 299088 0
Condition category
Condition code
Reproductive Health and Childbirth 299119 299119 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Silicon irregular hexagonal pessary is a non surgical device used for conservative management of pelvic organ prolapse. Participants meeting the study inclusion criteria will be given the information and consent form. The randomisation process takes place once the subject agreed to participate in the study. The allocation will be concealed in an envelope to prevent selection bias. Once the participants been allocated to particular treatment group, the initial pessary pessary fitting by undertaken by doctors and subsequent appointments for pessary change will be undertaken by nurse specialists at pessary clinic. All participants are required to complete the following questionnaires on the first visit before the pessary fitting. They are: (i) Pelvic Floor Distress Inventory Questionnaires (PFDI-20) to assess the severity of pelvic organ prolapse symptoms and impact on bowel and bladder function; (ii) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires (PISQ-12) to measure sexual function in women with pelvic floor disorders; and (iii) Euro Qol Health Questionnaires (EQ-5D) to assess current health status. These are the recommended questionnaires by the international pelvic floor society, International Consultation on Incontinence (ICI) that have been validated to assess quality of life in women with pelvic floor disorders.

After completing the questionnaires, subjects will be fitted with a vaginal pessary. The pessary size will be determined on a ‘best-fit’ basis by the clinician fitting the pessary. Topical vaginal oestrogen therapy (Ovestin 1mg/g or Vagifem 10mcg twice weekly) will be prescribed based on clinician preference from the first visit for post-menopausal subjects unless it is contraindicated such as history of breast cancer. Subjects are recommended to use the vaginal oestrogen therapy as long as the pessary is in place. The continuous daily pessary use and the use of vaginal oestrogen therapy will not be monitored as part of the study. Subjects will be reviewed at 1 week to assess correct pessary size and the nurse specialist will instruct subjects to perform self-care of the pessary. This will include teaching the subjects methods to remove, clean and replace their pessary once a week. Subjects who are unable to comply with the recommended self-care advice will be considered as failure in self-care. However, patients continuing to use pessary for 6 months will still be considered as a treatment success whether or not they are able to achieve self-care.

For subjects continuing pessary use, further reviews will be undertaken at 6 and 12 months. At these visits, the existing pessaries will be replaced with the same type of pessary that was used. Any adverse events such as vaginal bleeding, discharge, or odour that might indicate vaginal infection and ulceration that is reported by subjects will be recorded at each follow up visits. Subjects with symptomatic vaginal ulceration will have the pessary left out and will be reviewed after 2 weeks to ensure resolution of the problem before replacing the pessary. Subjects with suspected vaginal infection will have a vaginal swab taken and given an antibiotic prescription for treatment. Subjects will be to self report to the clinic if they have any issues in between visits or if the pessary is expelled at any stage. We have appointed Dr Oliver Daly (Urogynaecologist) to be in Data and Safety Monitoring Committee for this study. However, any serious adverse events will be reported to the Royal Women’s Hospital Ethics Committee and Therapeutic Goods Administration (TGA).
Intervention code [1] 295005 0
Treatment: Devices
Comparator / control treatment
The PVC ring pessary will be used as non surgical management of pelvic organ prolapse. Subjects meeting the study inclusion criteria will be given the information and consent form before the randomization. The subjects will subsequently receive a concealed allocation to either the silicon irregular hexagonal pessary or the PVC ring pessary using computer-generated randomization (STAT TREK). The pessary will be inserted by doctors at Urogynaecology clinic (The Royal Women's Hospital, Melbourne or private rooms at Frances Perry House) or nurse specialists at pessary clinic (The Royal Women's Hospital). All subjects will be required to complete the following questionnaires on the first visit before the pessary fitting. They are: (i) Pelvic Floor Distress Inventory Questionnaires (PFDI-20) to assess the severity of pelvic organ prolapse symptoms and impact on bowel and bladder function; (ii) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires (PISQ-12) to measure sexual function in women with pelvic floor disorders; and (iii) Euro Qol Health Questionnaires (EQ-5D) to assess current health status. These are the recommended questionnaires by the international pelvic floor society, International Consultation on Incontinence (ICI) that have been validated to assess quality of life in women with pelvic floor disorders.

After completing the questionnaires, subjects will be fitted with a vaginal pessary. The pessary size will be determined on a ‘best-fit’ basis by the clinician fitting the pessary. Topical vaginal oestrogen therapy (Ovestin 1mg/g or Vagifem 10mcg twice weekly) will be prescribed based on clinician preference from the first visit for post-menopausal subjects unless it is contraindicated such as breast cancer. Subjects are recommended to use the vaginal oestrogen therapy as long as the pessary is in place. The continuous daily pessary use and the use of vaginal oestrogen therapy will not be monitored as part of the study. Subjects will be reviewed at 1 week to assess correct pessary size and the nurse specialist will instruct subjects to perform self-care of the pessary. This will include teaching the subjects methods to remove, clean and replace their pessary once a week. Subjects who are unable to comply with the recommended self-care advice will be considered as failure in self-care. However, patients continuing to use pessary for 6 months will still be considered as a treatment success whether or not they are able to achieve self-care.

For subjects continuing pessary use, further reviews will be undertaken at 6 and 12 months. At these visits, the existing pessaries will be replaced with the same type of pessary that was used. Any adverse events such as vaginal bleeding, discharge, or odour that might indicate vaginal infection and ulceration that is reported by subjects will be recorded at each follow up visits. Subjects with symptomatic vaginal ulceration will have the pessary left out and will be reviewed after 2 weeks to ensure resolution of the problem before replacing the pessary. Subjects with suspected vaginal infection will have a vaginal swab taken and given an antibiotic prescription for treatment. Subjects will be to self report to the clinic if they have any issues in between visits or if the pessary is expelled at any stage. We have appointed Dr Oliver Daly (Urogynaecologist) to be in Data and Safety Monitoring Committee for this study. However, any serious adverse events will be reported to the Royal Women’s Hospital Ethics Committee and Therapeutic Goods Administration (TGA).
Control group
Active

Outcomes
Primary outcome [1] 298599 0
The measure of primary outcome will be treatment success for the two pessaries. Treatment success will be defined as retention of the pessary at 6 months and 12 months post randomisation
Timepoint [1] 298599 0
Outcome will be assessed at 6 and 12 months (primary timepoint) post randomisation
Secondary outcome [1] 324697 0
Proportion of subjects able to perform self-care during pessary use, This will be self reported by subjects whether or not they are able to perform self care.
Timepoint [1] 324697 0
at 6 months and 12 months post randomisation
Secondary outcome [2] 344145 0
Subjects’ satisfaction with pessary treatment based on quality of life questionnaires:
(i) Pelvic Floor Distress Inventory Questionnaires (PFDI-20) to assess the severity of pelvic organ prolapse symptoms and impact on bowel and bladder function;
(ii) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires (PISQ-12) to measure sexual function in women with pelvic floor disorders; and
(iii) Euro Qol Health Questionnaires (EQ-5D) to assess current health status
Timepoint [2] 344145 0
At 6 months and 12 months post randomisation
Secondary outcome [3] 344146 0
Adverse events such as vaginal discharge, bleeding, offensive odour and vaginal ulceration will be assessed using Pelvic Organ Pessary Symptoms Questionnaires (POP-SQ)
Timepoint [3] 344146 0
at 6 months and 12 months post randomisation

Eligibility
Key inclusion criteria
At least 18 years old with symptomatic POP
Able to speak and read English
Not previously used a vaginal pessary for POP
At least stage II POP from any single compartment or a multi-compartment POP
Willing to use ring pessary
Willing and able to complete quality of life (QoL) questionnaires and attend follow-up visits
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate in the study
Unable to speak or read English
Women less than 18 years old
Previous vaginal pessary use
Prior prolapse surgery
Contraindicated to topical oestrogen therapy e.g. previous or current history of breast cancer
Unwilling to use a vaginal pessary
Unwilling and unable to complete QoL questionnaires and attend follow-up visits

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table generated by computer software (STAT TREK)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming a success rate of 20% for subjects allocated PVC ring pessary and 50% for silicon irregular hexagonal pessary respectively, 90 subjects (45 in each arms) will be required to achieve a power of 0.8 and significance level of 0.05. The success rate for PVC ring pessary is based on a success rate of 20% from the largest published study on pessary use. We propose to have an additional 15% subject recruitment to account for potential dropouts and incomplete data collection during the trial. Hence we plan to recruit a total of 104 (52 in each arms) subjects for this study. The data will be analyzed by intention to treat analyses.

We anticipate that we will see approximately 10 subjects per week eligible for the study at the Royal Women’s Hospital and Frances Perry House. Assuming a recruitment rate of 50% (i.e. 5 eligible subjects per week), the duration of time required to complete the recruitment process will be around 21 weeks. We therefore propose to conduct this study for a total duration of 24 months (i.e. 12 months of recruitment then follow up participants at 12 months)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5957 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 5960 0
Frances Perry House - Parkville
Recruitment hospital [3] 13437 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 13382 0
3052 - Parkville
Recruitment postcode(s) [2] 26043 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 293800 0
Hospital
Name [1] 293800 0
The Royal Women's Hospital Urogynaecology Department
Address [1] 293800 0
The Royal Women's Hospital
Locked Bag 300
Parkville
Victoria 3052
Country [1] 293800 0
Australia
Funding source category [2] 298862 0
Self funded/Unfunded
Name [2] 298862 0
Dr Marcus Carey
Address [2] 298862 0
Dr Marcus Carey
Suite B, Level 2, 20 Flemington Road,
Parkville, Victoria 3052
Country [2] 298862 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
The Royal Women's Hospital
Locked Bag 300
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 292632 0
Individual
Name [1] 292632 0
Dr Marcus Carey
Address [1] 292632 0
Dr Marcus Carey
Suite B, Level 2, 20 Flemington Road,
Parkville, Victoria 3052
Country [1] 292632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295232 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 295232 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Ethics committee country [1] 295232 0
Australia
Date submitted for ethics approval [1] 295232 0
15/06/2016
Approval date [1] 295232 0
07/09/2016
Ethics approval number [1] 295232 0
16/22

Summary
Brief summary
The primary aim of this study is to compare the success rates of the new POP pessary compared to the conventional PVC ring pessary. Treatment success will be defined as retention of the pessary at 6 months follow-up. The secondary objectives are to evaluate subjects’ ability to perform self-care during pessary use, subjects’ satisfaction with pessary treatment and complications.

Compared to surgery, vaginal pessaries have been the subjects of minimal scientific research. In particular, long-term vaginal pessary usage has been poorly studied.Whilst there are various shaped vaginal pessaries available it is standard clinical practice is to use a polyvinyl chloride (PVC) ring pessary that is usually changed or replaced every 6 months. With currently available pessaries, the overall retention rate of vaginal pessaries is low, due to discomfort, inconvenience, vaginal discharge or dislodgement. The failure rate (i.e. discontinuation with pessary usage) vary from 27% to 74%.

The limited efficacy of currently available vaginal pessaries is well recognized. In our unit we have conducted two studies relevant to vaginal pessary use. They were the vaginal dimensions based on vaginal casts taken from 60 women with pelvic organ prolapse and also biofilm formation on vaginal pessaries after 6 months of use. In order to reduce discharge associated with pessary use patients can be instructed in ‘self-care’ of their pessary by learning how to remove, clean and replace their pessary. However, some women find if difficult to remove and replace traditional PVC ring pessaries. Based on the results of these studies, we have developed a more anatomically shaped pessary. The additional ‘fold points’ in the rim of the pessary and a loop at the caudal end of the new pessary were incorporated into the design to enhance patients’ self-care during pessary use. The ‘fold points’ in the new pessary will make it more flexible (relative to the PVC pessary) during removal and replacement. A loop attached to the caudal aspect of the new pessary will facilitate removal of the pessary by the patient. With the above features, we have hypothesized that the new POP pessary will be at least 30% more successful than the conventional PVC ring pessary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66598 0
Dr Chin Hing Yong
Address 66598 0
The Royal Women's Hospital
Locked Bag 300
Parkville
Victoria 3052
Country 66598 0
Australia
Phone 66598 0
+613 8345 3143
Fax 66598 0
+613 8345 3147
Email 66598 0
chin.yong@thewomens.org.au
Contact person for public queries
Name 66599 0
Ms Ann Cornish
Address 66599 0
The Royal Women's Hospital
Locked Bag 300
Parkville
Victoria 3052
Country 66599 0
Australia
Phone 66599 0
+613 8345 3145
Fax 66599 0
+613 8345 3147
Email 66599 0
ann.cornish@thewomens.org.au
Contact person for scientific queries
Name 66600 0
Dr Chin Hing Yong
Address 66600 0
The Royal Women's Hospital
Locked Bag 300
Parkville
Victoria 3052
Country 66600 0
Australia
Phone 66600 0
+613 8345 3143
Fax 66600 0
+613 8345 3147
Email 66600 0
chin.yong@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not essential to share raw line-to-line data but will share study protocol and clinical study report once it is available
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1656 0
Study protocol
Citation [1] 1656 0
Link [1] 1656 0
Email [1] 1656 0
Other [1] 1656 0
Summary results
No Results