Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001076369
Ethics application status
Approved
Date submitted
20/06/2017
Date registered
25/07/2017
Date last updated
2/03/2021
Date data sharing statement initially provided
2/03/2021
Date results information initially provided
2/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the use of vaginal pessaries to assist women with symptomatic utero-vaginal prolapse in low-income countries
Scientific title
The effect of vaginal pessaries for women with symptomatic pelvic organ prolapse in low-income countries
Secondary ID [1] 292233 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
utero-vaginal prolapse 303728 0
Condition category
Condition code
Renal and Urogenital 303101 303101 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using vaginal pessaries in the management of women with symptomatic pelvic organ prolapse and teaching women to self-manage the pessary.

All eligible women presenting with symptomatic pelvic organ prolapse will be invited to participate.
All women participating or not, will be have a gynaecological history taken and examined. The pelvic organ prolapse will be documented using the standardised Pelvic Organ Prolapse Quantification (POPQ) score.
Women participating will have the vaginal pessary, its use and self-management instructions given in the local language by the local nurses. The pessary will initially be inserted by the local nurse and then by the woman as she learns to self-manage the pessary. The pessary is to be worn 24 hours per day for 3 days.
The woman will be shown how to remove the pessary, clean the pessary and how to reinsert the pessary by the local nurse. The nurse will provide one-on-one verbal and hands-on instructions.
No written instructions will be give as the women are usually illiterate and there are a number of local languages. No instructional images will be given as not to offend some women and their families by the gynaecological images because of cultural beliefs.

The pessary is a soft silicone device, round or oval in shape inserted into the vagina like a tampon, The pessary acts as a mechanical support device for the pelvic organ prolapse. This is an established method of treatment for pelvic organ prolapse.

On day 1 and day 3, the women will be reviewed by the nurses to ascertain if there are any problems with the pessary - did it fall out, is it comfortable, is it holding the prolapse up or if the woman has any other questions.
Intervention code [1] 298392 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302481 0
Primary outcome - pessary staying in-situ to support the pelvic organ prolapse.
Patients self-report and the local nurses reviews the patients
Timepoint [1] 302481 0
Baseline - insertion of pessary, 1 day post-insertion of pessary , 3 days post-insertion of pessary
Primary outcome [2] 302622 0
Local nurse will review daily on removal and reinsertion of pessary
Yes - to adequate self-removal and reinsertion of pessary
No - unable to remove and reinsert pessary
Timepoint [2] 302622 0
Days 1-3.
Patient reviewed by local nurses
Primary outcome [3] 302852 0
Patient comfort using Visual Analogue score (0-100%).
0 = no pain
100% = severe pain
Timepoint [3] 302852 0
Days 1-3.
Review by local nurses
Secondary outcome [1] 336151 0
Whether the women are able to self-manage the pessary.
The local nurse will review the women - either the women are able to remove and insert the pessaries themselves or not.
Timepoint [1] 336151 0
baseline- insertion of pessary, 1 day post-insertion of pessary, 3 days post-insertion of pessary

Eligibility
Key inclusion criteria
All women presenting with symptomatic pelvic organ prolapse
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women without prolapse
Women who refuse to try the pessary as a management option for prolapse
Women with cultural/religious beliefs precluding the use of pessary

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2017
Actual
5/09/2017
Date of last participant enrolment
Anticipated
Actual
2/01/2019
Date of last data collection
Anticipated
4/01/2022
Actual
Sample size
Target
80
Accrual to date
Final
93
Recruitment outside Australia
Country [1] 9001 0
Uganda
State/province [1] 9001 0
Kasese district
Country [2] 9002 0
Myanmar
State/province [2] 9002 0
Yangon
Country [3] 9003 0
Bangladesh
State/province [3] 9003 0
Dhaka

Funding & Sponsors
Funding source category [1] 296781 0
Charities/Societies/Foundations
Name [1] 296781 0
Health and Development Aid Abroad
Country [1] 296781 0
Australia
Primary sponsor type
Individual
Name
Judith Goh AO
Address
Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Hospital
Greenslopes QLD 4120
Country
Australia
Secondary sponsor category [1] 295762 0
None
Name [1] 295762 0
Address [1] 295762 0
Country [1] 295762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298006 0
Greenslopes Ethics & Research Committee
Ethics committee address [1] 298006 0
Greenslopes Hospital
Newdegate Street
Greenslopes QLD 4120
Ethics committee country [1] 298006 0
Australia
Date submitted for ethics approval [1] 298006 0
28/06/2017
Approval date [1] 298006 0
05/09/2017
Ethics approval number [1] 298006 0
Protocol 13/71

Summary
Brief summary
Pelvic organ prolapse is a common problem for women throughout the millennia. About 50% of women who have had vaginal births will develop a vaginal prolapse later in life but only about 10% are symptomatic. The prolapse is similar to a hernia, presenting as a lump protruding out of the vagina. The management of prolapse includes pelvic floor physiotherapy, vaginal pessary and surgery. Surgery is generally limited to women who have completed their family. The pessary for prolapse is a mechanical support device, inserted into the vagina to elevate the prolapse.

The use of pessaries to assist women with uterovaginal prolapse have been used for over 2 thousand years. Hippocrates used sea-sponge or half a pomegranate, inserted into the vagina to elevate the prolapse. Over the years, as technology improved, different materials and shapes of pessaries have been used. Today, common materials used include PVC, plastics and silicone. Pessaries are used in Australia today, often as first line treatment of prolapse.

Women in low income countries develop significant prolapse because of the high number of children they deliver and the heavy workload e.g. carrying buckets of water, firewood, digging in the fields. For these women, the vaginal lump causes significant social issues and often their husbands do not accept their condition. Health care, in particular operations, are often too expensive for the women in poor rural areas.

Although there is ample data and trial in the use of pessaries for prolapse in high income countries, little is available for low income countries. This is partly due to lack of resource, knowledge and cost. Some women prefer to return to the doctor every 4-6 months for review of pessary. This can be avoided if the women are able to and willing to self-manage the pessary. Self-management of pessaries would reduce the cost as there will not be any transportation or health professional fees.

The aim of this study is to assess the feasibility of using vaginal pessaries in low income countries and to teach women to self-manage the pessaries.
Trial website
not applicable
Trial related presentations / publications
not applicable
Public notes
Nil
Attachments [1] 1803 1803 0 0
/AnzctrAttachments/373163-Patient Information Sheet pessary_JGoh .docx (Participant information/consent)
Attachments [2] 1806 1806 0 0
/AnzctrAttachments/373163(v20-06-2017-07-56-08)-Consent Form_JGoh.docx (Participant information/consent)

Contacts
Principal investigator
Name 75710 0
Prof Judith Goh AO
Address 75710 0
Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country 75710 0
Australia
Phone 75710 0
+61 7 38479909
Fax 75710 0
+61 7 38476433
Email 75710 0
[email protected]
Contact person for public queries
Name 75711 0
Prof Judith Goh AO
Address 75711 0
Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country 75711 0
Australia
Phone 75711 0
+61 7 38479909
Fax 75711 0
+61 7 38476433
Email 75711 0
[email protected]
Contact person for scientific queries
Name 75712 0
Prof Judith Goh AO
Address 75712 0
Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country 75712 0
Australia
Phone 75712 0
+61 7 38479909
Fax 75712 0
+61 7 38476433
Email 75712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10841Ethical approval    373163-(Uploaded-28-12-2018-11-43-49)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.