RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS

Interstitial Cystitis, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06256679
• Other study ID #: TRASD- SUPERIOR HYPOGASTRIC
• Status: Completed
• Start date: December 27, 2022
• Est. completion date: June 27, 2023

Study information

• Verified date: February 2024
• Source: Turkish League Against Rheumatism
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis, Chronic
• Pelvic Pain

Intervention

Procedure:
• superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation
The L5-S1 intervertebral space was visualized using fluoroscopy. A 22G, 15 cm injection needle was advanced along the bilateral disc, and under lateral imaging, the needle position was confirmed anterior to the vertebral bodies. 2 ml of contrast solution was injected to confirm the correct needle placement, and then 8 mg of dexamethasone and 40 mg of bupivacaine (0.25%) were injected separately on each side. Two weeks later, patients who showed more than 50% improvement from the diagnostic block, as assessed by NRS, underwent a superior hypogastric pulsed radiofrequency procedure using a transdiscal technique with a 22G, 15 cm, 10 mm active-tipped radiofrequency needle at 42°C for 120 seconds. Two 50x50 mm electrode pads were placed on the posterior-superior aspect of the medial malleolus for posterior tibial nerve stimulation. Stimulation was delivered in continuous mode at a frequency of 20 Hz and a pulsed width of 200 ms. It was applied once a week for 30 min for 4 weeks.
• superior hypogastric plexus pulsed radiofrequency
The L5-S1 intervertebral space was visualized using fluoroscopy. A 22G, 15 cm injection needle was advanced along the bilateral disc, and under lateral imaging, the needle position was confirmed anterior to the vertebral bodies. After negative aspiration of blood, 2 ml of contrast solution was injected to confirm the correct needle placement, and then 8 mg of dexamethasone and 40 mg of bupivacaine (0.25%) were injected separately on each side. Two weeks later, patients who showed more than 50% improvement from the diagnostic block, as assessed by NRS, underwent a superior hypogastric pulsed radiofrequency procedure using a trans discal technique with a 22G, 15 cm, 10 mm active-tipped radiofrequency needle at 42°C for 120 seconds.

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkish League Against Rheumatism

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS)	NRS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.	Pre-intervention, 1st month, 3rd month
Primary	Neuropathic Pain 4 Questions (DN4)	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.	Pre-intervention, 1st month, 3rd month
Primary	The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)	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.	Pre-intervention, 1st month, 3rd month
Primary	Interstitial Cystitis Problem Index (ICPI)	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.	Pre-intervention, 1st month, 3rd month