RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS
NCT ID: NCT06256679
Last Updated: 2024-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
34 participants
OBSERVATIONAL
2022-12-27
2023-06-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
NCT01312259
Use of Medium Frequency Electrotherapy in the Treatment of OAB, LUTS and Pelvic Pain
NCT03520166
RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study
NCT06080217
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
NCT05977634
Radiofrequency in the Female Stress Urinary Incontinence
NCT02617797
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: SHP pulsed radiofrequency and TTNS
Patients with interstitial cystitis who received superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation.
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.
Group 2: SHP pulsed radiofrequency
Group 2 included patients with interstitial cystitis who received only superior hypogastric plexus pulsed radiofrequency.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with interstitial cystitis and experiencing symptoms for at least 3 months
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Turkish League Against Rheumatism
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muhammet Uğur ÖZTÜRK
Medical Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hacettepe University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRASD- SUPERIOR HYPOGASTRIC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.