A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis

UMIN ID: UMIN000001253

Registered date:16/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Interstitial cystitis
• Date of first enrollment: 2008/07/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 2 months (56days).
After that, the patients in hydrogen dissolution water group will be transferred to the additional intervention term after the end of intervention.
And after that, the patients will be randomized to withdrawal terms for more 1 month with hydrogen dissolution water or with placebo water.

The patients will be intervened with normal water (placebo group) 200ml every three times in a day in 2 months (56days)
After that, the patients in placebo water group will be given hydrogen water for more 1 month.

Outcome(s)

• Primary Outcome: The proportion of the patients who has been assessed "success" at the end of the intervention

Secondary Outcome

1) Changes of the Symptom Score in Interstitial Cystitis Symptom Index(ICSI)
2) Changes of the Problem Score in Interstitial Cystitis Problem Index(ICPI)
3) An Average frequency of urination per day
4) An Average voided volume at a time
5) Degree of urge to urinate; PUF symptom score
6) Degree of bladder pain
7) Impression by patients with GRA (Global Response Assessment)
8) Urine Test; 8-OHdG in urine
9) Adverse Events (we cannot deny the association between the food and the event)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female

Include criteria

1) Patients who are able to give written informed consent
2) Patients who has the characteristic finding under hydraulic distension of the bladder in interstitial cystitis by cystoscope
3) It has taken more than 12 weeks after patients took the hydraulic distension of the bladder, and symptom of patients are in stable.
4) More than 7 marks in total of Interstitial Cystitis Score in registration
5) More than 4 marks in Q4 (degree of bladder pain) in Interstitial Symptom Score
6) Age is over 20 years and less than 80 years
7) Patients are able to do the following things in this trial; getting good compliance with intaking investigating food and coming to hospital, and writing the diary and the questionnaire accurately by themselves

Exclude criteria

1) More than 200ml of an average voided volume at a time before the registration
2) Patients with active infection of urinary tract
3) Patients with bacterial cystitis within 12 weeks before registration
4) Patients with vaginosis
5) Patients with calculus of lower urinary tract or urethral diverticulum
6) Patients with nephrosis syndrome
7) Patients with active genital herpes
8) Patients who have operated the surgery in pelvis or its circumference and it has not taken more than 24 hours after the surgery
9) Patients with cerebrospinal disease
10) Patients with the follow disease or suspected disease; neurogenic bladder, cystitis radiation, tuberculous cystitis, cystitis with BCG, drug associated cystitis
11) Start, stop, or change of the dose of the following drugs within 4 weeks after the registration;
(a) Antiphlogistic analgetic
(b) Antidepressant
(c) Anticholinergic drug
(d) Antihistamine drug
(e) Ataractic drug
(f) Drug treatment for frequent urination and acraturesis
(g) Steroid drug
12) Start or stop new bladder training or diet therapy within 4 weeks befor registration
13) Patients who has received bladder instillation therapy, electrical stimulation therapy, or acupuncture and moxibustion within 12 weeks before registration
14) Patients with serious hepatic or kidney damage
15) Patients with serious heart disease
16) Patients with malignant tumors which effect their general status or survival time
17) Patients with the history of serious drug-induced adverse effect
18) Patients who are in pregnancy, while breast-feeding, or have possibilities of them, or desire pregnancy in test period
19) Patients who have taken part in the her clinical research within 12 weeks
20) Patients who have taken part in the her clinical research within 12 weeks
21) Patients who are inadequate, which their physicians assessed it

Related Information

• Primary Sponsor: Koushinkai Hospital
• Source(s) of Monetary Support: Public Health Research Foundation