Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment
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ClinicalTrials.gov Identifier: NCT01969773 |
Recruitment Status
:
Completed
First Posted
: October 25, 2013
Last Update Posted
: February 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Interstitial Cystitis | Drug: Botulinum toxin A Drug: Normal saline instillation | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | The patients were allocated to the treatment or control group by permuted block randomization code in a 2:1 ratio |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The attending doctors, patients, and study nurses did not know which solution was injected to their bladders, to keep the study in a double-blind condition. |
Primary Purpose: | Treatment |
Official Title: | Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial |
Actual Study Start Date : | December 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Botulinum toxin A
Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)
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Drug: Botulinum toxin A
Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)
Other Names:
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Placebo Comparator: Control arm-Normal saline instillation
Patients will be randomly assigned to receive intravesical injection of injection with normal saline.
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Drug: Normal saline instillation
Patients will be randomly assigned to receive intravesical injection of injection with normal saline.
Other Name: N/S
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- Net change of Patient Perception of Visual Analogue Scale (VAS) [ Time Frame: Baseline and 8 weeks ]
Efficacy:
The primary end-point of this study is the reduction of bladder pain at 8-week follow-up. If patient has a reduction of VAS pain score of 2 or more, they will be considered as successfully treated at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of Patient Perception of global response assessment (GRA) [ Time Frame: Baseline and 8 weeks ]
Efficacy:
The treatment outcome will be assessed by the global response assessment (GRA) to evaluate the overall perception of treatment resultant at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of O'Leary-Sant symptom and problem indexes [ Time Frame: Baseline and 8 weeks ]
Efficacy:
The IC symptoms will be assessed by the O'Leary-Sant symptom and problem indexes at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of the functional bladder capacity (FBC) [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Patients will be requested to keep a 3-day voiding diary prior to treatment to record the functional bladder capacity (FBC). Then the patients will be followed up at out-patient clinic at 8 weeks.
Safety:
Systemic adverse events
- Net change of the number of urinary frequency [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Patients will be requested to keep a 3-day voiding diary prior to treatment to record the number of urinary frequency at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of the number of nocturnal [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Patients will be requested to keep a 3-day voiding diary prior to treatment to record the number of nocturnal at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of the Quality of Life (QoL) [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Efficacy measured the net change of the Quality of Life (QoL) at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of the maximal flow rate (Qmax) [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Efficacy measured the net change of the maximal flow rate (Qmax) at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of the voided volume [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Efficacy measured the net change of the voided volume at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events
- Net change of the residual urine volume (PVR) [ Time Frame: Baseline and 8 weeks ]
Efficacy:
Efficacy measured the net change of the residual urine volume (PVR) at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.
Safety:
Systemic adverse events

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Ages Eligible for Study: | 20 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled.
- A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention.
- All patients have been treated with at least two types of treatment modalities including non-steroid anti-inflammatory drugs, oral pentosan polysulfate sodium (PPS), intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed.
Exclusion Criteria:
- Exclusion criteria proposed by NIDDK
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Automatic exclusions:
- Age <18 years old
- Benign or malignant bladder tumors
- Radiation cystitis Tuberculous cystitis
- Bacterial cystitis
- Vaginitis
- Cyclophosphamide cystitis
- Symptomatic urethral diverticulum
- Uterine, cervical, vaginal, or urethral cancer
- Active herpes
- Bladder or lower ureteral calculi
- Waking frequency <5 times in 12 hours
- Nocturia <2 times
- Symptoms relieved by antibiotics, urinary antiseptics, urinary analgesics (for example phenazopyridine hydrochloride)
- Duration < 12 months
- Involuntary bladder contractions (urodynamics)
- Capacity > 400ml, absence of sensory urgency
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Automatic inclusions:
1.Hunner's ulcer
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Positive factors: (two positive factors are necessary for inclusion)
- Pain on bladder filling relieved by emptying
- Pain (suprapubic, pelvic, urethral, vaginal or peripheral)
- Glomerulations on endoscopy
- Decreased compliance on cystometrogram
- Bladder distention is defined arbitrarily as 80 cm water pressure for 1 minute
- Use of Anticholinergic drugs, for the treatment of lower urinary tract symptoms who have an effect.
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up.
- Patients with bladder outlet obstruction on enrollment.
- Patients with urinary retention, PVR≥150 ml.
- Patients with uncontrolled confirmed diagnosis of acute urinary tract infection.
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Patients have laboratory abnormalities at screening including:
- Alanine aminotransferase (ALT) > 3 x upper limit of normal range
- Aspartate aminotransferase (AST) > 3 x upper limit of normal range.
- Patients have abnormal serum creatinine level > 2 x upper limit of normal range.
- Can not be used in the treatment of patients with transurethral catheter treatment.
- Pregnant and lactating women or women who intend to become pregnant during the study or have myasthenia gravis, Eaton Lambert syndrome.
- Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial.
- Patients participated investigational drug trial within 1 month before entering this study.
- Written informed consent has been obtained.
- Patient who did not complete the 3-day micturition diary according to the instruction.
- Intestinal bladder augmentation patients receive angioplasty for the treatment of overactive bladder.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969773
Taiwan | |
Buddhist Tzu Chi General Hospital | |
Hualien, Taiwan, 970 |
Principal Investigator: | Hann-Chorng Kuo, M.D. | Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University |
Publications:
Responsible Party: | Hann-Chorng Kuo, Director of Urology, Buddhist Tzu Chi General Hospital |
ClinicalTrials.gov Identifier: | NCT01969773 History of Changes |
Other Study ID Numbers: |
TCGHUROL009 |
First Posted: | October 25, 2013 Key Record Dates |
Last Update Posted: | February 17, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | IPD was not planned to share |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital:
Botulinum Toxin A (BoNT-A) Interstitial Cystitis |
Additional relevant MeSH terms:
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA abobotulinumtoxinA incobotulinumtoxinA |
Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |