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

NCT03913819 | Recruiting

• 1 other identifier: CRE-2011.454
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Voiding Dysfunction; Substance Abuse

Outcome Measures

Primary Outcomes (5)

• Change in total Bladder Capacity after standardized treatment.

  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

  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

  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

  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

  By patient reporting

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

Study Arms (1)

substance abuse group

Patients with voiding dysfunction secondary to substance abuse in a special clinic

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

Interventions

First line treatment: oral NSAID and anticholinergic agents DRUG

oral NSAID and anticholinergic agents

substance abuse group

Second line treatment: additional treatment for pain control DRUG

Gabapentin, tramadol, Lyrica

substance abuse group

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

A course of intravesical hyaluronate will be given.

substance abuse group

Fourth line treatment: surgical intervention PROCEDURE

Consideration of hydrodistention and augmentation cystoplasty

substance abuse group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1000 patients suffered from substance abuse induced voiding dysfunction.

You may qualify if:

• Patients suffered substance abuse induced voiding dysfunction

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (6)

• Middela S, Pearce I. Ketamine-induced vesicopathy: a literature review. Int J Clin Pract. 2011 Jan;65(1):27-30. doi: 10.1111/j.1742-1241.2010.02502.x.

  PMID: 21155941 BACKGROUND

• Wood D, Cottrell A, Baker SC, Southgate J, Harris M, Fulford S, Woodhouse C, Gillatt D. Recreational ketamine: from pleasure to pain. BJU Int. 2011 Jun;107(12):1881-4. doi: 10.1111/j.1464-410X.2010.10031.x. Epub 2011 Feb 14.

  PMID: 21314885 BACKGROUND

• Smith HS. Ketamine-induced urologic insult (KIUI). Pain Physician. 2010 Nov-Dec;13(6):E343-6. No abstract available.

  PMID: 21102971 BACKGROUND

• Hanno P, Lin A, Nordling J, Nyberg L, van Ophoven A, Ueda T, Wein A; Bladder Pain Syndrome Committee of the International Consultation on Incontinence. Bladder Pain Syndrome Committee of the International Consultation on Incontinence. Neurourol Urodyn. 2010;29(1):191-8. doi: 10.1002/nau.20847.

  PMID: 20025029 BACKGROUND

• Marinkovic SP, Moldwin R, Gillen LM, Stanton SL. The management of interstitial cystitis or painful bladder syndrome in women. BMJ. 2009 Jul 31;339:b2707. doi: 10.1136/bmj.b2707. No abstract available.

  PMID: 19648180 BACKGROUND

• Dimitrakov J, Kroenke K, Steers WD, Berde C, Zurakowski D, Freeman MR, Jackson JL. Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review. Arch Intern Med. 2007 Oct 8;167(18):1922-9. doi: 10.1001/archinte.167.18.1922.

  PMID: 17923590 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cholinergic Antagonists; Analgesia

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Anesthesia and Analgesia

Central Study Contacts

Chi Fai Ng, MD

CONTACT

852-3505-2625; ngcf@surgery.cuhk.edu.hk

Pui Tak Lai, BN

CONTACT

852-3505-1663; francolai@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 12, 2019
• Study Start: December 10, 2011
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

HK (1)