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
ACTRN12611000032954
Ethics application status
Approved
Date submitted
17/12/2010
Date registered
10/01/2011
Date last updated
10/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Surgical management and outcome of recurrent pelvic organ prolapse after mesh-surgery for the condition of a pelvic organ prolapse (mesh-failure)
Scientific title
Surgical management and outcome of recurrent pelvic organ prolapse after mesh-surgery for the condition of a pelvic organ prolapse (mesh-failure)
Secondary ID [1] 253313 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent pelvic organ prolapse 258849 0
Condition category
Condition code
Surgery 258990 258990 0 0
Surgical techniques
Renal and Urogenital 259034 259034 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The key research question is to assess and evaluate the surgical management and outcome of the applied surgical intervention in women with recurrent pelvic organ prolapse (POP) after initial treatment with synthetic mesh in the vagina for POP (mesh-failure).
The applied surgical management will be assessed and evaluated. The key research question is the assessment of the surgical management which can vary from patient to patient depending on the previous surgery. Follow-up time is 6 weeks and 3 months postoperatively. The overall duration of this observational study will be 12 months.
Intervention code [1] 257768 0
Not applicable
Comparator / control treatment
no control group is required. This study is conducted as a case-series. All women undergoing prolapse surgery for the condition of a recurrent prolapse after mesh-surgery (mesh-failure) will be included in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259841 0
Assessment and evaluation of the applied intervention for the treatment of women with recurrent POP after mesh-failure.
All patient will complete the Queensland Pelvic Floor Questionnaire as well as examined according to the ICS-POP-Q staging pre-and postoperatively as routinely performed in any patients undergoing prolapse surgery
Timepoint [1] 259841 0
Preoperatively, 6 weeks and 3 months after surgery as routinely performed in patients undergoing prolapse surgery
Secondary outcome [1] 268700 0
To assess the failure of the applied intervention all patient will be asked to complete the Queensland Pelvic Floor Questionnaire and the principal investigatior will examine the patients according to the ICS-POP-Q staging pre-and postoperatively as routinely performed in any patients undergoing prolapse surgery.
Timepoint [1] 268700 0
6 weeks and 3 months postoperatively

Eligibility
Key inclusion criteria
Women with a recurrent pelvic organ prolapse with previous mesh surgery for this condition (mesh-failure) are included in this study
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with recurrent prolapse with no history of mesh application for this condition

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258232 0
Self funded/Unfunded
Name [1] 258232 0
Country [1] 258232 0
Australia
Primary sponsor type
Individual
Name
Corina Schmid
Address
Department for Urogynaecology RBHW
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 257399 0
None
Name [1] 257399 0
Address [1] 257399 0
Country [1] 257399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260212 0
Institutional Review Board (IRB) for Low and Negligible Risk Research RBWH
Ethics committee address [1] 260212 0
Royal Brisbane and Womens Hospital
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 260212 0
Australia
Date submitted for ethics approval [1] 260212 0
Approval date [1] 260212 0
22/11/2010
Ethics approval number [1] 260212 0

Summary
Brief summary
The purpose of the proposed project is to report the clinical presentation, the subsequent surgical management and the outcome of a series of 20 patients with recurrent pelvic organ prolapse (POP) following implantation of synthetic mesh in the vagina for the treatment of POP (mesh-failure). This study is conducted to obtain a better understanding of the surgical management after vaginal mesh-failure that should be proposed.
The hypothesis of this study is to evaluate and to assess the surgical treatment in women who underwent surgical correction for recurrent POP after initial treatment with synthetic mesh in the vagina for POP. For gynaecologist clear surigcal strategies are required to propose the surgical intervention that is most effection in this situation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32030 0
Address 32030 0
Country 32030 0
Phone 32030 0
Fax 32030 0
Email 32030 0
Contact person for public queries
Name 15277 0
Corina Schmid
Address 15277 0
Department Urogynaecology RBWH
Butterfiel Street
Herston
QLD 4029
Country 15277 0
Australia
Phone 15277 0
+61 44 982 2896
Fax 15277 0
Email 15277 0
[email protected]
Contact person for scientific queries
Name 6205 0
Corina Schmid
Address 6205 0
Department Urogynaecology RBWH
Butterfiel Street
Herston
QLD 4029
Country 6205 0
Australia
Phone 6205 0
+61 44 9822896
Fax 6205 0
Email 6205 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.