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Clinical Trials/JPRN-UMIN000001253
JPRN-UMIN000001253
Completed
Phase 2

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

Koushinkai Hospital0 sites30 target enrollmentJuly 16, 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Interstitial cystitis
Sponsor
Koushinkai Hospital
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 16, 2008
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Koushinkai Hospital

Eligibility Criteria

Inclusion 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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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