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Clinical Trials/NCT06256679
NCT06256679
Completed
N/A

SUPERIOR HYPOGASTRIC PLEXUS PULSED RADIOFREQUENCY COMBINED WITH POSTERIOR TIBIALIS NERVE TRANSCUTANEOUS RADIOFREQUENCY AS A TREATMENT OPTION OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS

Turkish League Against Rheumatism1 site in 1 country34 target enrollmentDecember 27, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Interstitial Cystitis, Chronic
Sponsor
Turkish League Against Rheumatism
Enrollment
34
Locations
1
Primary Endpoint
The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Interstitial cystitis/painful bladder syndrome is a collection of symptoms that includes urinary urgency, urge incontinence, nocturia, and painful urination. Various treatment modalities are utilized in the management of the disease. Superior hypogastric plexus block, which is used in the treatment of chronic pelvic pain, is one of these treatment methods. Additionally, tibial nerve stimulation is used in the treatment of urinary symptoms. This study aims to compare the effectiveness of superior hypogastric plexus pulsed radiofrequency and adjunctive transcutaneous tibial nerve stimulation in the treatment of patients with interstitial cystitis

Registry
clinicaltrials.gov
Start Date
December 27, 2022
End Date
June 27, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Turkish League Against Rheumatism
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Uğur ÖZTÜRK

Medical Doctor

Turkish League Against Rheumatism

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18-65 years
  • Diagnosed with interstitial cystitis and experiencing symptoms for at least 3 months

Exclusion Criteria

  • Pregnancy or breastfeeding
  • Patients with renal, hepatic, cardiovascular, or psychiatric diseases
  • Additional interventional treatments within the first 3 months after the procedure
  • A history of previous surgery or trauma

Outcomes

Primary Outcomes

The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)

Time Frame: Pre-intervention, 1st month, 3rd month

The ICSI contains 4 items that measure urgency and frequency of urination, nighttime urination, and pain or burning. The ICSI score is is evaluated between 0 and 20. A high score indicates a bad result.

Numerical Rating Scale (NRS)

Time Frame: Pre-intervention, 1st month, 3rd month

NRS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.

Interstitial Cystitis Problem Index (ICPI)

Time Frame: Pre-intervention, 1st month, 3rd month

ICPI is a form that investigates how much problems the symptoms of interstitial cystitis cause. ICPI score is evaluated between 0 and 16. A high score indicates a bad result.

Neuropathic Pain 4 Questions (DN4)

Time Frame: Pre-intervention, 1st month, 3rd month

DN4 is a screening questionnaire to help identify neuropathic pain in clinical practice and research. This leads to a score range of 0-10 when the symptoms (range 0-7 points) as well as the signs (range 0-3 points) items are included. A high score indicates a bad result.

Study Sites (1)

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