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Trial record 48 of 158 for:    interstitial cystitis

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

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ClinicalTrials.gov Identifier: NCT02517996
Recruitment Status : Terminated (Preliminary results were promising when interim analysis performed but terminated due to primary investigators left recruitment site.)
First Posted : August 7, 2015
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Painful Bladder Syndrome Drug: Lidocaine Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Preemptive Pudendal Nerve Block Prior to Hydrodistension for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS): a Prospective, Double-blinded, Randomized Control Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1% Lidocaine
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters 1% lidocaine after anesthesia induction.
Drug: Lidocaine
Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.

Placebo Comparator: Normal Saline
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Drug: Placebo
Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
Other Name: Normal Saline




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in pain at 2 hours, 2 weeks, 6 weeks, and 3 months postoperatively in patients undergoing hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline) using the visual analog scale (VAS).

  2. Change in IC Symptom Index Questionnaire with Preemptive Pudendal Nerve Block Compared to Saline [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in interstitial cystitis symptom index at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline).

  3. Change in Problem Index (O'Leary Sant) with Preemptive Pudendal Nerve Block Compared to Saline [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in problem index (O'Leary Sant) at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline).

  4. Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire with Preemptive Pudendal Nerve Block Compared to Saline [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in pelvic urgency, pain and frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline).

  5. Change in IC Symptom Index Questionnaire with and without Preemptive Pudendal Nerve Block [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in interstitial cystitis symptom index at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention without preemptive pudendal nerve block.

  6. Change in Problem Index (O'Leary Sant) with and without Preemptive Pudendal Nerve Block [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in problem index (O'Leary Sant) at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention without preemptive pudendal nerve block.

  7. Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire with and without Preemptive Pudendal Nerve Block [ Time Frame: Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months) ]
    To determine the change in pelvic urgency, pain and frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention without preemptive pudendal nerve block.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517996


Locations
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United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Tola Fashokun, M.D. Johns Hopkins University

Publications:
Wu, C. Y., Chen, I., & Tong, Y. C. (2013). Long-term treatment outcomes in patients with interstitial cystitis/painful bladder syndrome: 10-year experience in NCKUH. Urological Science, 24(1), 10-13

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02517996     History of Changes
Other Study ID Numbers: IRB00034476
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Pain
Disease
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action