Clinical trial NCT01895153: Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome
Official title: The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Pain Syndrome
Pentosan Polysulfate
Hydrodistension
Keywords: bladder pain syndrome
pentosan polysulfate
hydrodistension
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bladder pain syndrome patients have not been treated with hydrodistention.

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


Eligibility criteria: Inclusion Criteria:

1. men and women who were over 18 years old and had symptoms over 6 months.
2. 4 or more with an pain visual analogue score
3. 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:

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

Primary outcomes:
measure: the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment
timeFrame: 6months
Secondary outcomes:
measure: The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment.
timeFrame: 1,2,4 and 6months after each treatment .
measure: The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment
timeFrame: 1,2,4 and 6months after each treatment .
measure: The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)
timeFrame: 1,2,4 and 6months after each treatment .
measure: The change of Global Response Assessment(GRA) score
timeFrame: 1,2,4 and 6months after each treatment .
measure: The change of EQ-5D Health Questionnaire score
timeFrame: 1,2,4 and 6months after each treatment .
measure: The change of Brief Pain Inventory-short form(BPI-sf) score
timeFrame: 1 and 6months after each treatment.
measure: The estimation of safty and Complications for each treatment
timeFrame: 1,2,4 and 6months after each treatment .
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: