Investigation of the Effectiveness of Acupuncture in Patients Diagnosed With Interstitial Cystitis

NCT06232200 | Completed

• 1 other identifier: 34043404
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Interstitial Cystitis; Bladder Pain Syndrome

Keywords

acupuncture; Interstitial Cystitis; Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  1. 6. ve 12. month

Study Arms (2)

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.

Other: ACUPUNCTURE

Interventions

ACUPUNCTURE OTHER

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.

ACUPUNCTUR GROUP

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who diagnosed IC/BPS
• between 30-65 years old
• female

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

istanbul Çam Sakura city hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28326514 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2024-02

Locations

TU (1)