Effect of investigative laparoscopy on bladder pain syndrome: a prospective cohort trial

Not Applicable

Completed

• Conditions: Bladder Pain Syndrome; Endometriosis; Renal and Urogenital - Other renal and urogenital disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12613000977774
• Lead Sponsor: The Royal Women’s Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-02
• Study Completion: 2017-12-15
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[12 months post procedure]