Interstitial Cystitis, ChronicNCT06256679
RADIOFREQUENCY TREATMENT OF CHRONIC PELVIC PAIN MANAGEMENT IN INTERSTITIAL CYSTITIS
An observational study of Interstitial Cystitis, Chronic, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Cystitis, Chronic
- What is being tested?
- superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation and superior hypogastric plexus pulsed radiofrequency
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2022to 27 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18-65 years
- Diagnosed with interstitial cystitis and experiencing symptoms for at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Medicine
Ankara
About this study
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
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
- Being tested
- superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation, superior hypogastric plexus pulsed radiofrequency
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulationProcedure or surgery
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 radiofrequencyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SHP pulsed radiofrequency and TTNS | Patients with interstitial cystitis who received superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation. Receives: 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. Receives: Procedure: superior hypogastric plexus pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention, 1st month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start27 Dec 2022
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Cystitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Uğur ÖZTÜRK, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256679
- Sponsor's protocol ID
- TRASD- SUPERIOR HYPOGASTRIC
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06256679
- Acronym / sponsor ID
- TRASD- SUPERIOR HYPOGASTRIC
- Conditions
- Interstitial Cystitis, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: SHP pulsed radiofrequency and TTNS | – | Procedure: superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulationPatients with interstitial cystitis who received superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulation. |
| Group 2: SHP pulsed radiofrequency | – | Procedure: superior hypogastric plexus pulsed radiofrequencyGroup 2 included patients with interstitial cystitis who received only superior hypogastric plexus pulsed radiofrequency. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 18-65 years
- Diagnosed with interstitial cystitis and experiencing symptoms for at least 3 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superior hypogastric plexus pulsed radiofrequency and transcutaneous tibial nerve stimulationThe 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. | Procedure or surgery | Group 1: SHP pulsed radiofrequency and TTNS |
| superior hypogastric plexus pulsed radiofrequencyThe 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. | Procedure or surgery | Group 2: SHP pulsed radiofrequency |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis, Chronic, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: Pre-intervention, 1st month, 3rd month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.