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Completed

NCT Number: NCT06256679

RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS

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

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Key information

Conditions

Interstitial Cystitis, Chronic Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Turkish League Against Rheumatism

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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