A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia

NCT01048177 | Withdrawn Phase 2

• 1 other identifier: IRB-09-5381
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In order to investigate whether the pain in women with vulvodynia may represent bladder origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women with generalized vulvodynia. Those women with a positive test for IC, we will be performing a series of bladder treatments (instillations) for IC and checking symptoms throughout the trial to see if significant relief of vulvar pain can be obtained through treatment for IC.

Conditions

Vulvodynia

Keywords

vulvodynia; interstitial cystitis; pelvic pain

Outcome Measures

Primary Outcomes (1)

• Reduction in pelvic pain / vulvodynia

  16 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Bladder instillation with heparin/ lidocaine

Interventions

Bladder instillation with heparin/ lidocaine DRUG

9 bladder instillations in 6 weeks

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We plan to enroll women 18 years or older with GV and negative tests for urine infection, negative cultures for Chlamydia and gonorrhea when indicated, and negative screens or cultures for yeast infection or bacterial vaginosis when indicated.
• Patient symptoms will need to include no or minimal vaginal discharge.
• Patients will have a minimum Visual Analog Score for vulvar pain of at least 3/10.
• In order to receive bladder instillations, patients will need to have a positive potassium sensitivity test.

You may not qualify if:

• We will exclude patients from enrollment if they use chronic narcotic pain medication or have localized vulvodynia. (We believe that localize vulvodynia is less likely of bladder origin).

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Clinic

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Vulvodynia; Cystitis, Interstitial; Pelvic Pain

Interventions

Administration, Intravesical; Heparin; Lidocaine

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Glycosaminoglycans; Polysaccharides; Carbohydrates; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bruce Kahn, M.D.

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (1)