Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01895153

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.

Condition or Disease	Intervention/Treatment	Phase
Bladder Pain Syndrome Pentosan Polysulfate Hydrodistension

Study Design

Study Type:

Observational

Actual Enrollment :

91 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
pentosan polysulfate cohort pentosan polysulfate monotherapy
hydrodistension(HD) cohort hydrodistension(HD) monotherapy
combination cohort combination therapy of pentosan polysulfate and hydrodistension.

Outcome Measures

Primary Outcome Measures

the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment [6months]

Secondary Outcome Measures

The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment. [1,2,4 and 6months after each treatment .]
The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment [1,2,4 and 6months after each treatment .]
The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) [1,2,4 and 6months after each treatment .]
The change of Global Response Assessment(GRA) score [1,2,4 and 6months after each treatment .]
The change of EQ-5D Health Questionnaire score [1,2,4 and 6months after each treatment .]
The change of Brief Pain Inventory-short form(BPI-sf) score [1 and 6months after each treatment.]
The estimation of safty and Complications for each treatment [1,2,4 and 6months after each treatment .]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

men and women who were over 18 years old and had symptoms over 6 months.
4 or more with an pain visual analogue score
12 or more O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q) symptom and problem score and with a pain score and nocturia score of 2 or more.

Exclusion Criteria:

history of hydrodistention,augumentation cystoplasty due to IC/BPS
pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
Women of child-bearing potential who were pregnant or nursing
mean voided volume lesser than 40ml or over than 400ml.
hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
urinary tract infection during run-in periods.
genitourinary tuberculosis or bladder,urethral and prostate cancer
recurrent urinary tract infection
history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.