ANZCTR - Registration

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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

utero-vaginal prolapse

Condition category

Condition code

Renal and Urogenital

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]

Treatment: Devices

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary outcome - pessary staying in-situ to support the pelvic organ prolapse.
Patients self-report and the local nurses reviews the patients

Timepoint [1]

Baseline - insertion of pessary, 1 day post-insertion of pessary , 3 days post-insertion of pessary

Primary outcome [2]

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]

Days 1-3.
Patient reviewed by local nurses

Primary outcome [3]

Patient comfort using Visual Analogue score (0-100%).
0 = no pain
100% = severe pain

Timepoint [3]

Days 1-3.
Review by local nurses

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Uganda

State/province [1]

Kasese district

Country [2]

Myanmar

State/province [2]

Yangon

Country [3]

Bangladesh

State/province [3]

Dhaka

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Health and Development Aid Abroad

Address [1]

PO Box 733
Ashmore City QLD 4214

(patient care/pessary donated. Researcher's time not funded)

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Ethics & Research Committee

Ethics committee address [1]

Greenslopes Hospital
Newdegate Street
Greenslopes QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/06/2017

Approval date [1]

05/09/2017

Ethics approval number [1]

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]

/AnzctrAttachments/373163-Patient Information Sheet pessary_JGoh .docx (Participant information/consent)

Attachments [2]

/AnzctrAttachments/373163(v20-06-2017-07-56-08)-Consent Form_JGoh.docx (Participant information/consent)

Contacts

Principal investigator

Name

Prof Judith Goh AO

Address

Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country

Australia

Phone

+61 7 38479909

Fax

+61 7 38476433

[email protected]

Contact person for public queries

Name

Judith Goh AO

Address

Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country

Australia

Phone

+61 7 38479909

Fax

+61 7 38476433

[email protected]

Contact person for scientific queries

Name

Judith Goh AO

Address

Suite 209
Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120

Country

Australia

Phone

+61 7 38479909

Fax

+61 7 38476433

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Patient confidentiality

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10841	Ethical approval					373163-(Uploaded-28-12-2018-11-43-49)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically