MedTrace Logo

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

NCT03913819 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-05-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913819 on ClinicalTrials.gov