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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01895153

Enrollment

Registered

2013-07-10

Start date

2012-04-30

Completion date

2020-05-31

Last updated

2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Pain Syndrome, Hydrodistension, Pentosan Polysulfate

Keywords

bladder pain syndrome, pentosan polysulfate, hydrodistension

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment.	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 .
The change of EQ-5D Health Questionnaire score	1,2,4 and 6months after each treatment .

Countries

South Korea

Outcome results