Voiding DysfunctionNCT03913819
Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
An observational study of Voiding Dysfunction and Substance Abuse, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Voiding Dysfunction, Substance Abuse
- What is being tested?
- First line treatment: oral NSAID and anticholinergic agents, Third line treatment: A course of intravesical hyaluronate will be given. and Fourth line treatment: surgical intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Dec 2011to 30 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1000 patients suffered from substance abuse induced voiding dysfunction.
Who may be able to join
- Patients suffered substance abuse induced voiding dysfunction
Who cannot join
- Patient not agreed for consent
- Patient that will not comply to our treatment protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 3953, ngcf@surgery.cuhk.edu.hk
Pui Tak LAI, BN, 3505 1663, francolai@surgery.cuhk.edu.hk
About this study
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
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.
Read the 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.
- Conditions
- Voiding Dysfunction, Substance Abuse
- Being tested
- First line treatment: oral NSAID and anticholinergic agents, Second line treatment: additional treatment for pain control, Third line treatment: A course of intravesical hyaluronate will be given., Fourth line treatment: surgical intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First line treatment: oral NSAID and anticholinergic agentsDrug
oral NSAID and anticholinergic agents
Second line treatment: additional treatment for pain controlDrug
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 interventionProcedure or surgery
Consideration of hydrodistention and augmentation cystoplasty
| Study group | Role | What they receive |
|---|---|---|
| substance abuse group | Patients with voiding dysfunction secondary to substance abuse in a special clinic Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total Bladder Capacity after standardized treatment.
Total bladder capacity is assessed by the sum of voided volume and post-voided volume
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 4 months, 8 months, 12 months, every 4 months through study completion, and average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start10 Dec 2011
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913819
- Sponsor's protocol ID
- CRE-2011.454
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21155941Wood 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.
PubMed 21314885Smith HS. Ketamine-induced urologic insult (KIUI). Pain Physician. 2010 Nov-Dec;13(6):E343-6. No abstract available.
PubMed 21102971Hanno 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.
PubMed 20025029Marinkovic 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.
PubMed 19648180Dimitrakov 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.
PubMed 17923590