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

April 23, 2025 updated by: Ali Ihsan Memmi, Medipol University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • istanbul Çam Sakura city hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
REGULAR TREATMENT
Experimental: ACUPUNCTUR GROUP
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1. 6. ve 12. month

Secondary Outcome Measures

Outcome Measure
Time Frame
Bladder Pain/İnterstitial Cystitis Symptom Score (BPIC-SS)
Time Frame: 1. 6. ve 12. month
1. 6. ve 12. month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34043404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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