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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients suffered substance abuse induced voiding dysfunction

Disqualifiers

Patient not agreed for consent

Patient that will not comply to our treatment protocol

Trial population

1000 patients suffered from substance abuse induced voiding dysfunction.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • First line treatment: oral NSAID and anticholinergic agents

    Drug

    oral NSAID and anticholinergic agents

  • Second line treatment: additional treatment for pain control

    Drug

    Gabapentin, tramadol, Lyrica

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

    Drug

    A course of intravesical hyaluronate will be given.

  • Fourth line treatment: surgical intervention

    Procedure/Surgery

    Consideration of hydrodistention and augmentation cystoplasty

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: substance abuse group4 interventions

Trial outcomes

Primary outcomes

1

Change in total Bladder Capacity after standardized treatment.

Total bladder capacity is assessed by the sum of voided volume and post-voided volume

Time frame
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
2

Change in Pain level after standardized treatment: Pelvic Pain - Urgency Frequency symptom scale

Using the 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
3

Change in Bladder storage function after standardized treatment

Using Overactive Bladder Symptom Score

Time frame
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
4

Change in Bladder voiding function after standardized treatment

Using the International Prostate Symptom Score

Time frame
Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year

Secondary outcomes

Other outcomes

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