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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000977774

Enrollment

150

Registered

2013-09-02

Start date

2013-09-09

Completion date

2016-09-30

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

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)

Outcome results