None listed
Conditions
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.
Interventions
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, i
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.
Sponsors
Judith Goh AO
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All women presenting with symptomatic pelvic organ prolapse
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
Outcome results
None listed