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Trial registered on ANZCTR


Registration number
ACTRN12613000977774
Ethics application status
Approved
Date submitted
1/08/2013
Date registered
2/09/2013
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Date results information initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of investigative laparoscopy on bladder pain syndrome: a prospective cohort trial
Scientific title
Effect of investigative laparoscopy on bladder pain syndrome: a prospective cohort trial
Secondary ID [1] 282948 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Pain Syndrome 289772 0
Endometriosis 289773 0
Condition category
Condition code
Renal and Urogenital 290115 290115 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 290298 290298 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to use questionnaires to assess the impact of laparoscopic treatment of endometriosis on bladder pain syndrome in women already scheduled for surgery. Laparoscopy, also known as key hole surgery, will involve the removal of endometriosis dependant on the individual patient findings. Duration is variable from 30mins if no endometriosis is found, to a number of hours if there is extensive endometriosis requiring removal. The study will use questionnaires preoperatively which will be compared at three, six and twelve months post procedure to assess symptoms. This study is observational and does not involve altering surgical intervention that has already been scheduled. This study will only use questionnaires to asses the outcome of patients who are having this intervention as part of their clinical management.
Intervention code [1] 287654 0
Not applicable
Comparator / control treatment
Participants in this study will fall into one of four groups which will enable comparisons between symptoms to be made.
The group that a participant is allocated to is dependant on their surgical findings, as this cannot be confirmed until after the procedure.
All patients involved in the study are scheduled to undergo laparoscopy for investigation of chronic pelvic pain. If endometriosis is found during the surgery, it will be removed. If no endometriosis is found then no tissue removal will be performed. These findings will be collated and each participant allocated to one of four groups depending on these findings.
1) Group 1: Women with endometriosis and bladder pain syndrome
2) Group 2: Women with endometriosis and no bladder pain syndrome
3) Group 3: Women with no endometriosis and bladder pain syndrome
4) Group 4: Women with no endometriosis and no bladder pain syndrome
Control group
Active

Outcomes
Primary outcome [1] 290148 0
The primary outcome measure is bladder pain reduction at 12 months following endometriosis surgery with bladder pain reduction being defined as a >/=50% bladder pain reduction by the Visual Analogue Scale (VAS).
Timepoint [1] 290148 0
12 months post procedure
Secondary outcome [1] 304019 0
1) Examine the relationship between women with endometriosis over the uterovesical pouch and bladder pain syndrome. This will be assessed using a combination of the VAS (visual analogue scale), PUF (pelvic pain and urgency/frequency), O’Leary Sant Symptom and Problem Index and BPIC-SS (bladder pain / interstitial cystitis symptom score) questionnaires.
Timepoint [1] 304019 0
12 months
Secondary outcome [2] 304310 0
2) Compare consistency of bladder symptoms reporting by patients on the VAS (visual analogue scale), PUF (pelvic pain and urgency/frequency), O’Leary Sant Symptom and Problem Index and BPIC-SS (bladder pain / interstitial cystitis symptom score) questionnaires.
Timepoint [2] 304310 0
3 month, 6 month and 12month comparison points
Secondary outcome [3] 304311 0
3) Measure the rate of de novo bladder pain syndrome that occurs following a laparoscopy in subjects with pelvic pain but no prior bladder pain syndrome and no demonstrable endometriosis. This will be assessed using the VAS (visual analogue scale) and the PUF (pelvic pain and urgency/frequency) questionnaires. Pre operative questionnaire results will be compared to patients 3month, 6 month and 12 month post operative questionnaire responses.
Timepoint [3] 304311 0
3 month, 6 month and 12 month comparison points
Secondary outcome [4] 304312 0
4) Measure the rate of de novo bladder pain syndrome that occurs following a laparoscopy in subjects with pelvic pain and endometriosis but no prior bladder pain syndrome. This will be assessed using the O’Leary Sant Symptom and Problem Index and BPIC-SS (bladder pain / interstitial cystitis symptom score) questionnaire. Pre operative questionnaire results will be compared to patients 12 month post operative questionnaire responses.
Timepoint [4] 304312 0
12 months
Secondary outcome [5] 304313 0
5) Measure the change in bladder pain at 12 months following laparoscopy in subjects with bladder pain syndrome but no endometriosis. This will be assessed using the O’Leary Sant Symptom and Problem Index and BPIC-SS (bladder pain / interstitial cystitis symptom score) questionnaire. Pre operative questionnaire results will be compared to patients responses at 12 months post procedure.
Timepoint [5] 304313 0
12 months

Eligibility
Key inclusion criteria
1) Pelvic Pain >6months, who have been booked for laparoscopy as part of their investigation.
2) Age 18-40yo.
3) Subjects both with and without symptoms of bladder pain syndrome.
4) Adequate English to gain informed consent.
5) Patient consents to participation in trial.
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) English not adequate to gain informed consent.
2) Presence of urinary tract infection as determined by a midstream urine culture or haematuria requiring further investigation.
3) Women who do not consent.
4) Confusable diseases (except endometriosis) will be excluded or deemed unlikely based on clinical grounds by the treating clinician. Clinical investigations required to exclude confusable diseases may comprise urine cytology, microbiology; or imaging. These conditions include recurrent UTI’s; radiation cystitis; chemical cystitis; infective cystitis (schistosomisais; TB; mycoplasma gentalium; chlamydia; ureaplasma;; bladder calculi; urethral diverticulum)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
SAMPLE SIZE
To achieve a clinically significant change of equal or greater than 50% reduction in pain on the visual analogue scale for pain with a full bladder from the median of 6/10 that was determined in the study by Cheng et el, a sample size of 10 was determined. A minimum of 30 participants was chosen to be used in each of the four groups. This will account for drop outs and non responders and to provide adequate representation. Sample size calculation was performed using STATA version 11.0 with a power of 0.9, alpha value of 0.05, SD 1.9. In addition the larger sample size allows a greater opportunity to address some of the secondary outcomes

ANALYSIS
At completion of the study analysis will involve comparing proportions using Chi squared tests and comparing continuous variable measures using t-test or if variance is not equal the Welch’s t-test. If the data does not have a normal distribution then a non-parametric tests such as the Mann Whitney U test will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1383 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 1384 0
Frances Perry House - Parkville
Recruitment postcode(s) [1] 7245 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 287724 0
Self funded/Unfunded
Name [1] 287724 0
This study is a low cost study, all costs to be covered by the investigators.
Address [1] 287724 0
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052

Country [1] 287724 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women’s Hospital
Address
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 286454 0
None
Name [1] 286454 0
Address [1] 286454 0
Country [1] 286454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289682 0
The Royal Women's Hospital Ethics Committee
Ethics committee address [1] 289682 0
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 289682 0
Australia
Date submitted for ethics approval [1] 289682 0
01/05/2013
Approval date [1] 289682 0
15/07/2013
Ethics approval number [1] 289682 0

Summary
Brief summary
Chronic pelvic pain is a frustrating condition for many women, having a variety of potential causes including endometriosis, adenomyosis, pelvic inflammatory disease, adhesions, irritable bowel syndrome and bladder pain syndrome (BPS). Endometriosis is considered the main cause with a prevalence of 70-90% in women with chronic pelvic pain. A number of recent trials have found that bladder pain syndrome also is an important differential diagnosis to consider with studies showing 53-89% of women with chronic pelvic pain have bladder pain syndrome. Similarly studies have also reported the high prevalence of having concomitant bladder pain syndrome and endometriosis with a study by Cheng et el in 2011, finding 60% of women with BPS also had endometriosis.

This study aims to assess the impact of laparoscopy and more specifically surgical treatment of endometriosis on bladder pain syndrome. The study will use questionnaires preoperatively which will be compared at three, six and twelve months post procedure. The primary outcome measure will be bladder pain reduction at 12 months following endometriosis surgery with bladder pain reduction being defined as a >/=50% bladder pain reduction by the Visual Analogue Scale (VAS).
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 41922 0
Dr Rachel Collings
Address 41922 0
Locked Bag 300
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 41922 0
Australia
Phone 41922 0
+61 3 8345 2000
Fax 41922 0
Email 41922 0
rachel.collings2@gmail.com
Contact person for public queries
Name 41923 0
Dr Rachel Collings
Address 41923 0
Locked Bag 300
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 41923 0
Australia
Phone 41923 0
+61 3 8345 2000
Fax 41923 0
Email 41923 0
rachel.collings2@gmail.com
Contact person for scientific queries
Name 41924 0
Dr Rachel Collings
Address 41924 0
Locked Bag 300
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 41924 0
Australia
Phone 41924 0
+61 3 8345 2000
Fax 41924 0
Email 41924 0
rachel.collings2@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Will not be available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6738 0
Ref.: Ms. No. IUJO-D-19-00211R1
Effect of investigative laparoscopy on bladder pain syndrome: a prospective cohort trial
International Urogynecology Journal, 2019
https://doi.org/10.1007/s00192-019-04023-7
Attachments [1] 6738 0
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
A total of one hundred and fifty patients were included in the trial. Seventy five percent of patients (n=112/150) were diagnosed with endometriosis. Of them, 43% (n=48/112) also had BPS. The overall BPS rate was 43% (n=64/150). At 12 months, there was a significant reduction in overall pain and pelvic pain in all groups. Of the women with BPS, there was no difference in symptom score reduction between those with endometriosis treated and those without endometriosis. BPS resolved in 36-47% of women twelve months post laparoscopy, regardless of whether endometriosis was diagnosed and treated or not. Of the women without BPS pre-operatively, 10-17% developed de-novo BPS at twelve months, regardless of whether endometriosis was diagnosed and treated or not.