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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Review of sacrospinous fixation surgery for treatment of vaginal prolapse in Bangladesh and Nepal
Scientific title
Prolapse recurrence following sacrospinous colpopexy for the management of pelvic organ prolapse in Bangladesh and Nepal
Secondary ID [1] 294306 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pelvic organ prolapse 307013 0
Condition category
Condition code
Surgery 306108 306108 0 0
Surgical techniques
Reproductive Health and Childbirth 306109 306109 0 0
Other reproductive health and childbirth disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prolapse usually presents as a protrusion or lump from the vagina. When the prolapse is large, the upper vagina usually descends also and if surgical treatment is undertaken, upper vaginal support/repair is required.
In 2015, sacrospinous colpopexy was introduced to various sites in Bangladesh to treat women with pelvic organ prolapse. Prior to this, only the vaginal hysterectomy and repair without upper vagina support was employed during surgical repairs of prolapse.
Following surgery, women are usually reviewed at 6 weeks, 6 months and 12 months to assess for recurrence of prolapse.
This examination will be done by the local health professionals. If one of the investigators is in Bangladesh during the follow up visit, we will/have examine the woman with the local health professionals. At other times of follow up, the local health professionals will review the women and document the findings in the chart and these charts will be reviewed
Intervention code [1] 300607 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group

Primary outcome [1] 305137 0
Pelvic organ prolapse stage 3 or more on clinical examination at presentation.
The information will be obtained in the medical history/records
Timepoint [1] 305137 0
6 weeks post-surgery, 6 months post-surgery, 12 months post-surgery (primary endpoint)
Secondary outcome [1] 344299 0
symptomatic recurrent pelvic organ prolapse. This will be obtained from patient medical records
Timepoint [1] 344299 0
6 weeks post-surgery, 6 months post surgery

Key inclusion criteria
Who have had pelvic organ prolapse surgery with sacrospinous fixation
Minimum age
30 Years
Maximum age
85 Years
Can healthy volunteers participate?
Key exclusion criteria
Women who have had prolapse surgery with sacrospinous fixation
Women declining to enter study
Women declining vaginal examination

Study design
Defined population
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 9677 0
State/province [1] 9677 0
Country [2] 9678 0
State/province [2] 9678 0

Funding & Sponsors
Funding source category [1] 298953 0
Self funded/Unfunded
Name [1] 298953 0
Address [1] 298953 0
Country [1] 298953 0
Primary sponsor type
Prof Judith Goh
Suite 209, Ramsay Specialist Centre
Greenslopes Hospital
Newdegate St
Greenslopes QLD 4120
Secondary sponsor category [1] 298165 0
Name [1] 298165 0
Dr Hannah Krause
Address [1] 298165 0
Suite 209, Ramsay Specialist Centre
Greenslopes Hospital
Newdegate St
Greenslopes QLD 4120
Country [1] 298165 0
Secondary sponsor category [2] 298166 0
Name [2] 298166 0
Dr Barbara Hall
Address [2] 298166 0
c/o Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country [2] 298166 0
Secondary sponsor category [3] 298169 0
Name [3] 298169 0
Ms Anubha Rawat
Address [3] 298169 0
DAK Foundation
48B Egerton St
Silverware NSW 2128
Country [3] 298169 0

Ethics approval
Ethics application status
Ethics committee name [1] 299889 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 299889 0
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Ethics committee country [1] 299889 0
Date submitted for ethics approval [1] 299889 0
Approval date [1] 299889 0
Ethics approval number [1] 299889 0
Protocol 18/19

Brief summary
Pelvic organ prolapse is a common problem for women. It presents a lump or bulge extending out from the vagina. About fifty percent of women who have had vaginal childbirth will develop prolapse later in life and in about 20 percent of these women, the prolapse is symptomatic and the woman will seek treatment. Traditionally surgery has been the mainstay of treatment but other options include pelvic floor rehabilitation and the use mechanical devices (pessary).

In 2015, the investigators were approached by to up-skill gynaecologists in the area of vaginal prolapse surgery in low-income countries, in particular, Bangladesh and Nepal. It was brought to the attention of the local gynaecologist that surgeries performed did not provide optimal outcomes and we were approached to provide expert feedback and means to upskill the local gynaecologists.

In 2015, we went to Bangladesh to assess women and surgeries performed. As a result of this, we introduced the concept of vault or upper vagina support during vaginal surgery pelvic reconstructive surgery, that is, the sacrospinous colpopexy procedure. This procedure is commonly performed by gynaecologist, in particular, urogynaecologists in Australia during vaginal prolapse surgery to support the upper vagina. If this is not performed, then the prolapse of the upper vaginal (even after a hysterectomy) is not treated and will prolapse out again.

Since 2015, we have been training the local gynaecologists in a number of locations in Bangladesh and Nepal to perform the sacrospinous colpopexy.

The aim of this study is to review the charts of women who have undergone this surgery to ascertain prolapse recurrence rates. This audit will provide information regarding the main anatomical areas of prolapse recurrence, and hence focus continuing education in these particular areas.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 81878 0
Prof Judith Goh
Address 81878 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 81878 0
Phone 81878 0
+61 7 38479909
Fax 81878 0
+61 7 38476433
Email 81878 0
Contact person for public queries
Name 81879 0
Prof Judith Goh
Address 81879 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 81879 0
Phone 81879 0
+61 7 38479909
Fax 81879 0
+61 7 38476433
Email 81879 0
Contact person for scientific queries
Name 81880 0
Prof Judith Goh
Address 81880 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 81880 0
Phone 81880 0
+61 7 38479909
Fax 81880 0
+61 7 38476433
Email 81880 0

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?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Journal publication details
Publication date and citation/details [1] 10843 0
October 2020
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary