RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS

Completed

• Conditions: Interstitial Cystitis, Chronic
• Interventions: Procedure: superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation; Procedure: superior hypogastric plexus pulsed radiofrequency

• Registration Number: NCT06256679
• Lead Sponsor: Turkish League Against Rheumatism

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: SHP pulsed radiofrequency and TTNS	superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation	Patients with interstitial cystitis who received superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation.
Group 2: SHP pulsed radiofrequency	superior hypogastric plexus pulsed radiofrequency	Group 2 included patients with interstitial cystitis who received only superior hypogastric plexus pulsed radiofrequency.

Primary Outcome Measures

Name	Time	Method
The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)	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)	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)	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)	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.

Trial Locations

Locations (1)

Hacettepe University Faculty of Medicine; 🇹🇷 Ankara, Turkey