Interstitial CystitisNCT06232200
Investigation of the Effectiveness of Acupuncture in Patients Diagnosed With Interstitial Cystitis
A study testing ACUPUNCTURE in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Interstitial cystitis/bladder pain syndrome is a non-bacterial chronic inflammatory disease of the bladder characterized by lower urinary tract symptoms such as dysuria, irritating urgency, and nocturia, as well as pelvic pain associated with bladder filling. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- ACUPUNCTURE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- who diagnosed IC/BPS
- between 30-65 years old
- female
Who cannot join
- Patients who do not meet the IC/BPS diagnostic criteria,
- who have previously received acupuncture treatment,
- who have localized skin infections involving the acupuncture areas,
- who have bleeding diathesis and who use anticoagulant drugs,
- who cannot comply with the treatment and follow-up schedule will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation Of The Effectiveness Of Acupuncture In Patients Diagnosed With Treatment-resistant Interstitial Cystitis/Bladder Pain Syndrome
Interstitial cystitis/bladder pain syndrome is a non-bacterial chronic inflammatory disease of the bladder characterized by lower urinary tract symptoms such as dysuria, irritating urgency, and nocturia, as well as pelvic pain associated with bladder filling.
The International Continence Society (ICS) defines bladder pain syndrome as "a complaint of suprapubic pain due to bladder filling accompanied by urinary system symptoms such as increased daytime and nighttime urinary frequency as a result of the exclusion of proven urinary infection or other obvious pathologies." Acupuncture is an important treatment method of traditional Chinese medicine that has been used for more than 2500 years and is performed by placing needles at specific points on the skin.
Read more
In the literature, clinical studies have been conducted to evaluate the effectiveness of acupuncture in Interstitial Cystitis and its effectiveness in relieving symptoms has been demonstrated. In the light of these data, our aim in our multi-centered study is to investigate the effectiveness of acupuncture in relieving symptoms and improving the quality of life in patients diagnosed with Interstitial Cystitis.
In our study, patients who applied to the Urology Clinic between 01.02.2024 and 01.07.2024 with pelvic pain or discomfort lasting more than 6 months and lower urinary tract symptoms such as frequent urination, dysuria and nocturia will be examined and evaluated with suspicion of Interstitial Cystitis diagnosis.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- ACUPUNCTURE
- Keywords
- acupuncture, Interstitial Cystitis, Bladder Pain Syndrome
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUPUNCTUREOther
Acupuncture application will be performed by bilateral needling of The Sanyinjiao (SP6), Yin Ling Quan (SP9), Zu San Li, "Leg Three Mile" (ST36) , Tai Chong (LIV3), Hegu (LI4), Taixi (KID3) , Zhongliao (BL33) and Guan Yuan (CV4) acupuncture points using sterile, disposable metal acupuncture needles. The needles will remain in place for approximately 20 minutes during the treatment, a total of 8 sessions are planned, 2 per week.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | REGULAR TREATMENT |
| ACUPUNCTUR GROUP | Experimental | Acupuncture application will be performed by bilateral needling of The Sanyinjiao (SP6), Yin Ling Quan (SP9), Zu San Li, "Leg Three Mile" (ST36) , Tai Chong (LIV3), Hegu (LI4), Taixi (KID3) , Zhongliao (BL33) and Guan Yuan (CV4) acupuncture points using sterile, disposable metal acupuncture needles. The needles will remain in place for approximately 20 minutes during the treatment, a total of 8 sessions are planned, 2 per week. Receives: Other: ACUPUNCTURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Leary-Saint symptom score
The O'Leary-Saint symptom score is also known as the Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index (ICPI). That assesses the 4 core symptoms of Interstitial Cystitis (bladder pain, urgency, frequent urination, and nocturia) by asking the patient how often each is experienced. In this evaluation, the patient is asked to rate the 4 basic symptoms in the Interstitial Cystitis Symptom Index from 0 to 5, according to the patient's complaint, and the 4 basic problems in the Interstitial Cystitis Problem Index from 0 to 4.The goal of this instrument is to evaluate and diagnose patients with IC. The O'Leary-Sant instrument is comprised of a Symptom Index (score range: 0-20 points) and a Problem Index (score range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. On either index, a score ≥6 points indicates Interstitial Cystitis.
Measured: 1. 6. ve 12. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- The conventional treatment group will be determined as the control group and the patients in the treatment group will receive acupuncture treatment twice a week, a total of 8 sessions.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232200
- Sponsor's protocol ID
- 34043404
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sonmez MG, Kozanhan B. Complete response to acupuncture therapy in female patients with refractory interstitial cystitis/bladder pain syndrome. Ginekol Pol. 2017;88(2):61-67. doi: 10.5603/GP.a2017.0013.
PubMed 28326514
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effectiveness Of Acupuncture In Patients Diagnosed With Treatment-resistant Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT06232200
- Acronym / sponsor ID
- 34043404
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- acupuncture, Interstitial Cystitis, Bladder Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 30 Jan 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/bladder pain syndrome is a non-bacterial chronic inflammatory disease of the bladder characterized by lower urinary tract symptoms such as dysuria, irritating urgency, and nocturia, as well as pelvic pain associated with bladder filling.
The International Continence Society (ICS) defines bladder pain syndrome as "a complaint of suprapubic pain due to bladder filling accompanied by urinary system symptoms such as increased daytime and nighttime urinary frequency as a result of the exclusion of proven urinary infection or other obvious pathologies." Acupuncture is an important treatment method of traditional Chinese medicine that has been used for more than 2500 years and is performed by placing needles at specific points on the skin.
In the literature, clinical studies have been conducted to evaluate the effectiveness of acupuncture in Interstitial Cystitis and its effectiveness in relieving symptoms has been demonstrated. In the light of these data, our aim in our multi-centered study is to investigate the effectiveness of acupuncture in relieving symptoms and improving the quality of life in patients diagnosed with Interstitial Cystitis.
In our study, patients who applied to the Urology Clinic between 01.02.2024 and 01.07.2024 with pelvic pain or discomfort lasting more than 6 months and lower urinary tract symptoms such as frequent urination, dysuria and nocturia will be examined and evaluated with suspicion of Interstitial Cystitis diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The conventional treatment group will be determined as the control group and the patients in the treatment group will receive acupuncture treatment twice a week, a total of 8 sessions.
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –REGULAR TREATMENT |
| ACUPUNCTUR GROUP | Experimental | Other: ACUPUNCTUREAcupuncture application will be performed by bilateral needling of The Sanyinjiao (SP6), Yin Ling Quan (SP9), Zu San Li, "Leg Three Mile" (ST36) , Tai Chong (LIV3), Hegu (LI4), Taixi (KID3) , Zhongliao (BL33) and Guan Yuan (CV4) acupuncture points using sterile, disposable metal acupuncture needles. The needles will remain in place for approximately 20 minutes during the treatment, a total of 8 sessions are planned, 2 per week. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who diagnosed IC/BPS
- between 30-65 years old
- female
Key exclusion criteria (5 listed)
- Patients who do not meet the IC/BPS diagnostic criteria,
- who have previously received acupuncture treatment,
- who have localized skin infections involving the acupuncture areas,
- who have bleeding diathesis and who use anticoagulant drugs,
- who cannot comply with the treatment and follow-up schedule will not be included in the study.
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 |
|---|---|---|
| ACUPUNCTUREAcupuncture application will be performed by bilateral needling of The Sanyinjiao (SP6), Yin Ling Quan (SP9), Zu San Li, "Leg Three Mile" (ST36) , Tai Chong (LIV3), Hegu (LI4), Taixi (KID3) , Zhongliao (BL33) and Guan Yuan (CV4) acupuncture points using sterile, disposable metal acupuncture needles. The needles will remain in place for approximately 20 minutes during the treatment, a total of 8 sessions are planned, 2 per week. | Other | ACUPUNCTUR GROUP |
Primary outcome
O'Leary-Saint symptom score
Time frame: 1. 6. ve 12. month
The O'Leary-Saint symptom score is also known as the Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index (ICPI). That assesses the 4 core symptoms of Interstitial Cystitis (bladder pain, urgency, frequent urination, and nocturia) by asking the patient how often each is experienced. In this evaluation, the patient is asked to rate the 4 basic symptoms in the Interstitial Cystitis Symptom Index from 0 to 5, according to the patient's complaint, and the 4 basic problems in the Interstitial Cystitis Problem Index from 0 to 4.The goal of this instrument is to evaluate and diagnose patients with IC. The O'Leary-Sant instrument is comprised of a Symptom Index (score range: 0-20 points) and a Problem Index (score range: 0-16 points), each of which contains four questions related to urinary and pain symptoms. For each index, the score is calculated by summing the points for each item. On either index, a score ≥6 points indicates Interstitial Cystitis.
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 30 Jun 2026.
- Background: PubMed 28326514Sonmez MG, Kozanhan B. Complete response to acupuncture therapy in female patients with refractory interstitial cystitis/bladder pain syndrome. Ginekol Pol. 2017;88(2):61-67. doi: 10.5603/GP.a2017.0013.
- Individual participant dataSharing planned: Undecided
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Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Recruiting
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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?
A study testing ACUPUNCTURE in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Medipol University 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 3 inclusion and 5 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 30 Jun 2026. 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?
O'Leary-Saint symptom score (time frame: 1. 6. ve 12. month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232200, which also lists 1 linked publication.
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 30 Jun 2026.