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

May 4, 2025 updated by: NG Chi Fai, Chinese University of Hong Kong

Prospective Longitudinal Study on the Treatment Outcomes of Various Treatment Modalities Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

1000 patients suffered from substance abuse induced voiding dysfunction.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
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
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
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
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
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
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
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
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2011

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2011.454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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