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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed in a multicenter, randomized, double-blind, placebo controlled trial to test the actual therapeutic effects of intravesical BoNTA injection. The results of this study might provide clinical evidence for a better therapeutic regimen in the treatment of IC/PBS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.