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Trial record 84 of 135 for:    AMITRIPTYLINE

Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction

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ClinicalTrials.gov Identifier: NCT03913819
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Chi Fai NG, Chinese University of Hong Kong

Brief Summary:

With the increase of substance abuse over the world, substance abuse e.g. ketamine and methamphetamine related voiding dysfunction is becoming an important medical problem. However, while the clinical manifestation of the condition is becoming better defined, the underlying pathophysiology is still poorly understood. Moreover, majority of the current treatment is just based on the experience on some small case series and there is no treatment data for larger patient sample or standard recommended treatment in the literature. In order to improve the management of this condition, investigators have formulated a treatment protocol based on the current literatures on the management of voiding dysfunction and also a similar condition, interstitial cystitis / painful-bladder syndrome (IC/PBS). The protocol basically consists of the following modalities:

  • Basic information and education on the condition, principle of treatment and psychosocial support.
  • First line treatment will include a course of oral anti-inflammatory drugs (for the control of the inflammation process and pain) and anticholinergic agents (for the irritative urinary symptoms).
  • If these simple oral medication are found to be not effective, then further treatment will include other oral medications, such as amitriptyline and gabapentin, and some drugs that directly applied into the bladder cavity (hyaluronate) or bladder muscle (botulinum toxin).
  • For those patients with intractable symptoms and failed all the above treatments, surgical treatment (hydrodistension, augmentation cystoplasty) will be discussed.

The purpose of this research is to assess the effectiveness of the above treatment protocol in the management of substance induced voiding dysfunction and also assess any possible adverse events related to the usage of the drugs.


Condition or disease Intervention/treatment
Voiding Dysfunction Substance Abuse Drug: First line treatment: oral NSAID and anticholinergic agents Drug: Second line treatment: additional treatment for pain control Drug: Third line treatment: A course of intravesical hyaluronate will be given. Procedure: Fourth line treatment: surgical intervention

Detailed Description:

With the increase in recreational usage of various soft drugs, such as ketamine, methamphetamine over the world, substance abuse related voiding dysfunction is becoming an important medical problem. However, while the clinical manifestation of the condition is becoming better defined, the underlying pathophysiology is still poorly understood. Moreover, majority of the current treatment is based on the experience on some small case series and there is no treatment data for larger patient sample or standard recommended treatment in the literature. With the rapid increase in patients' demand, there is an urgent need for better clinical study on the effect of various treatment regimes for the condition, to provide more evidence-based recommendation for them. On the other hand, better treatment outcome will also help the rehabilitation of these substance abusers.

However, in Hong Kong, due to the limited funding in the tertiary care health system and the poor social support for the patients, some potential treatment options, including COX II inhibitors, intravesical hyaluronate, and botulinum toxin injection, etc, are not readily available for these patients. Therefore, some patients may receive sub-optimal treatment with more side effects or may have limited access to certain therapeutic options. The patients may have to suffer and this also affects the doctors' experience and hence the formulation of ideal treatment for these patients. If extra or adequate funding is available, it may not only widen the potential treatment options for these patients but also provide more clinical experience and data in guiding the formulation of treatment protocols / recommendation and even guide future research direction.

Therefore, in this proposal, investigators would like to prospectively study the treatment result of various treatment modalities under a standardized treatment protocol. The results will help to evaluate the effectiveness and also tolerability of various proposed treatment options in substance abused related voiding dysfunction. . Because of the certain similarities in the clinical manifestations and pathology of voiding dysfunction and interstitial cystitis / painful-bladder syndrome (IC/PBS), this treatment protocols (referred to later section) will base on standard recommendations of IC/PBS (including the American Urological Guideline) and literature on voiding dysfunction management. For treatment / medications that are not provided in Hospital Authority formulation, investigators will provide to patient if clinically indicated. Currently, because of the insufficient treatment data and also the behavioural characteristics of these substance abusers, it will be difficult or impractical to perform randomized placebo-controlled clinical trials in this area. As a result, a prospective longitudinal study on a standardized treatment protocol is proposed, which will provide some "Real-life practice" information on the management of these patients. The data gathered from this study may also provide basis for future study.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Longitudinal Study on the Treatment Outcomes of Various Treatment Modalities Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
Actual Study Start Date : December 10, 2011
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
substance abuse group
Patients with voiding dysfunction secondary to substance abuse in a special clinic
Drug: First line treatment: oral NSAID and anticholinergic agents
oral NSAID and anticholinergic agents

Drug: Second line treatment: additional treatment for pain control
Gabapentin, tramadol, Lyrica

Drug: Third line treatment: A course of intravesical hyaluronate will be given.
A course of intravesical hyaluronate will be given.

Procedure: Fourth line treatment: surgical intervention
Consideration of hydrodistention and augmentation cystoplasty




Primary Outcome Measures :
  1. Change in total Bladder Capacity after standardized treatment. [ Time Frame: Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year ]
    Total bladder capacity is assessed by the sum of voided volume and post-voided volume

  2. Change in Pain level after standardized treatment: Pelvic Pain - Urgency Frequency symptom scale [ Time Frame: Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year ]
    Using the Pelvic Pain - Urgency Frequency symptom scale

  3. Change in Bladder storage function after standardized treatment [ Time Frame: Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year ]
    Using Overactive Bladder Symptom Score

  4. Change in Bladder voiding function after standardized treatment [ Time Frame: Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year ]
    Using the International Prostate Symptom Score

  5. Any new Adverse events related to treatment modalities [ Time Frame: Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year ]
    By patient reporting



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1000 patients suffered from substance abuse induced voiding dysfunction.
Criteria

Inclusion Criteria:

  • Patients suffered substance abuse induced voiding dysfunction

Exclusion Criteria:

  • Patient not agreed for consent
  • Patient that will not comply to our treatment protocol

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): NCT03913819


Contacts
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Contact: Chi Fai Ng, MD 852-3505-2625 ngcf@surgery.cuhk.edu.hk
Contact: Pui Tak Lai, BN 852-3505-1663 francolai@surgery.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Chi Fai NG, MD    3505 3953    ngcf@surgery.cuhk.edu.hk   
Contact: Pui Tak LAI, BN    3505 1663    francolai@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong

Publications:
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Responsible Party: Chi Fai NG, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03913819     History of Changes
Other Study ID Numbers: CRE-2011.454
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs