Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

Stopped early · Not applicable · Has a placebo group

Conditions studied: Interstitial Cystitis, Painful Bladder Syndrome

In brief

Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its public health importance the pathogenesis of IC/PBS is not well understood and there is no consensus on the optimal treatment approach for this condition. Hydrodistention is the most commonly used therapy for this condition; but it is limited by severe immediate postoperative bladder pain and its short duration of action. It has been postulated that hydrodistention works by disrupting the sensory nerves within the bladder that may be contributing to bladder pain. Recent evidence has provided support for the use of preemptive pudendal nerve block as a way to blunt immediate postoperative pain. The investigators hypothesize that preemptive pudendal nerve block prior to hydrodistention will result in lower postoperative pain after hydrodistention compared to placebo. This is a prospective double- blinded randomized study and patients will be randomized to receive preemptive bilateral pudendal nerve block with either 1% lidocaine or placebo. Bladder pain will be compared at baseline, 2 hours, 2 weeks, 6 weeks and 3 months using the Visual Analog Scale, O'Leary-Sant questionnaire and the Pelvic Pain Urgency and Frequency questionnaire.

Key facts

Study ID

NCT02517996

Run by

Johns Hopkins University

People needed

18

Starts

2015-02-01

Expected to finish

2018-06-01

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All women aged greater than 18 years of age scheduled to undergo cystoscopy with hydrodistention
• who are literate,
• English speaking and
• can provide written informed consent will be included in this study.

You may not qualify if…

• Patients who have intolerance or known allergies to local analgesia will be excluded.
• In addition, patients who have coagulation disorders will also be excluded as this may increase their risks of complication from bleeding.
• Patient will also be excluded if they have a history of dementia as this may impair their ability to follow instructions.
• Patients who are non-ambulatory and who have an inability to fully assess pain will also be excluded.
• Patients receiving additional surgical procedures will be excluded from the study, as the source of their pain may be difficult to decipher in the immediate post-operative period.

Where it is running

• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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