RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS

NCT06256679 | Completed

• 1 other identifier: TRASD- SUPERIOR HYPOGASTRIC
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Interstitial Cystitis, Chronic

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Group 1: SHP pulsed radiofrequency and TTNS

Patients with interstitial cystitis who received superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation.

Procedure: superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation

Group 2: SHP pulsed radiofrequency

Group 2 included patients with interstitial cystitis who received only superior hypogastric plexus pulsed radiofrequency.

Procedure: superior hypogastric plexus pulsed radiofrequency

Interventions

superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation PROCEDURE

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.

Group 1: SHP pulsed radiofrequency and TTNS

superior hypogastric plexus pulsed radiofrequency PROCEDURE

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.

Group 2: SHP pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 34 patients diagnosed with interstitial cystitis by the urology department and experiencing symptoms for at least 3 months, who had undergone superior hypogastric nerve pulsed radiofrequency by our team, were retrospectively included in the study at the Algology Clinic of Hacettepe University Faculty of Medicine. Some of these patients had also undergone transcutaneous posterior tibial nerve stimulation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish League Against Rheumatism: lead

Study Sites (1)

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: December 27, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

TU (1)