Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01969773
• Date of registration: 22/10/2013
• Prospective Registration: No
• Primary sponsor: Buddhist Tzu Chi General Hospital
• Public title: Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment
• Scientific 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
• Date of first enrolment: December 2012
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01969773
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Hann-Chorng Kuo, M.D.
• Affiliation: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

Key inclusion & exclusion criteria

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

- Automatic exclusions:

1. Age <18 years old

2. Benign or malignant bladder tumors

3. Radiation cystitis Tuberculous cystitis

4. Bacterial cystitis

5. Vaginitis

6. Cyclophosphamide cystitis

7. Symptomatic urethral diverticulum

8. Uterine, cervical, vaginal, or urethral cancer

9. Active herpes

10. Bladder or lower ureteral calculi

11. Waking frequency <5 times in 12 hours

12. Nocturia <2 times

13. Symptoms relieved by antibiotics, urinary antiseptics, urinary analgesics (for
example phenazopyridine hydrochloride)

14. Duration < 12 months

15. Involuntary bladder contractions (urodynamics)

16. Capacity > 400ml, absence of sensory urgency

- Automatic inclusions:

1.Hunner's ulcer

- Positive factors: (two positive factors are necessary for inclusion)

1. Pain on bladder filling relieved by emptying

2. Pain (suprapubic, pelvic, urethral, vaginal or peripheral)

3. Glomerulations on endoscopy

4. Decreased compliance on cystometrogram

5. 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.

- Patients have laboratory abnormalities at screening including:

1. Alanine aminotransferase (ALT) > 3 x upper limit of normal range

2. Aspartate aminotransferase (AST) > 3 x upper limit of normal range.

3. 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.



Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Intervention(s)

Drug: Botulinum toxin A

Drug: Normal saline instillation

Primary Outcome(s)

Net change of Patient Perception of Visual Analogue Scale (VAS) [Time Frame: Baseline and 8 weeks]

Secondary Outcome(s)

Net change of Patient Perception of global response assessment (GRA) [Time Frame: Baseline and 8 weeks]

Net change of O'Leary-Sant symptom and problem indexes [Time Frame: Baseline and 8 weeks]

Net change of the number of urinary frequency [Time Frame: Baseline and 8 weeks]

Net change of the maximal flow rate (Qmax) [Time Frame: Baseline and 8 weeks]

Net change of the functional bladder capacity (FBC) [Time Frame: Baseline and 8 weeks]

Net change of the residual urine volume (PVR) [Time Frame: Baseline and 8 weeks]

Net change of the voided volume [Time Frame: Baseline and 8 weeks]

Net change of the number of nocturnal [Time Frame: Baseline and 8 weeks]

Net change of the Quality of Life (QoL) [Time Frame: Baseline and 8 weeks]

Secondary ID(s)

TCGHUROL009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors