Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome

NCT07698626 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2026YJSKTPG
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare two treatment plans for adults with bladder pain syndrome (also called interstitial cystitis), a disease that causes long-lasting bladder pain, frequent urination and urgent need to pee. All participants will receive standardized patient education and behavioral training to relieve urinary discomfort. Half of the participants will only get this behavioral intervention, while the other half will take oral venlafaxine in addition to the same behavioral training for 12 weeks. We will check patients' pain levels, urination frequency, sleep quality, mood and daily life ability at 1, 2, 6 and 12 weeks of treatment. The main goal is to see whether adding venlafaxine can better ease bladder pain and urinary symptoms without obvious side effects. This research will provide safer and more effective treatment suggestions for patients with bladder pain syndrome.

Conditions

Bladder Pain Syndrome; Chronic Pelvic Nociplastic Pain; Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Patient Self-reported Global Response Assessment (GRA)

  Binary clinical response endpoint, defined as significant overall improvement in bladder pain and urinary symptoms versus minimal/no improvement, completed by participants at the 12-week treatment endpoint.

  12 weeks after randomization

Secondary Outcomes (3)

• Mean Visual Analog Scale (VAS) Bladder Pain Score

  Baseline, Week 1, Week2, Week6, Week12

• Pelvic Pain and Urgency/Frequency (PUF) Total Score

  Baseline, Week 1, Week2, Week6, Week12

• O'Leary-Sant ICSI + ICPI Composite Symptom Score

  Baseline, Week 1, Week2, Week6, Week12

Study Arms (2)

Arm 1 Control Arm (n=70)

OTHER

Intervention Name: Education and Behavioral Modification Program (EBMP) Only Intervention Description: Standardized 12-week behavioral intervention including IC/BPS disease education, bladder irritant dietary restriction guidance, timed bladder training, pelvic floor relaxation training, stress and sleep adjustment guidance. No additional oral antidepressants, analgesics or NSAIDs permitted throughout trial. Weekly telephone follow-up for adherence monitoring.

Behavioral: Education and Behavioral Modification Program (EBMP) only

Arm 2 Experimental Arm (n=70)

EXPERIMENTAL

Intervention Name: Venlafaxine + Education and Behavioral Modification Program (EBMP) Intervention Description: Full identical EBMP intervention as control group, plus flexible-dose oral venlafaxine for 12 weeks. Week 1 starting dose: 75mg once daily evening administration; Week3 escalate to 150mg daily if well-tolerated; Week5 maximum titration up to 225mg daily based on individual tolerance and symptom improvement. Dose down-titration allowed for intolerable adverse events to identify individual maximum tolerated dose (MTD), maintained until week12 endpoint. No rescue analgesic, NSAID or other antidepressant allowed during study period. Weekly telephone follow-up to record drug compliance and adverse reactions.

Drug: Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP)

Interventions

Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP) DRUG

Oral venlafaxine with flexible dose titration for 12 weeks plus standardized EBMP. Initial dose 75mg once daily in week 1, escalate to 150mg daily at week 3, maximum up to 225mg daily based on tolerance and symptom improvement. All participants receive identical disease education, bladder training, dietary guidance and psychological stress management training weekly. No other antidepressants, NSAIDs or rescue analgesics are allowed during the trial.

Arm 2 Experimental Arm (n=70)

Education and Behavioral Modification Program (EBMP) only BEHAVIORAL

12-week standardized behavioral intervention without additional oral drugs, including IC/BPS disease education, bladder irritant dietary restriction, timed bladder training, pelvic floor relaxation training and sleep/stress adjustment guidance. Weekly telephone follow-up to monitor adherence; no antidepressants or analgesics permitted throughout the study period.

Arm 1 Control Arm (n=70)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years (all genders) Confirmed IC/BPS diagnosis fulfilling AUA 2015 and ESSIC standardized diagnostic criteria, ruled out confounding urologic disorders Predominant lower urinary tract symptoms present for most days in the past 3 months Baseline bladder/pelvic pain and urinary frequency score ≥ 3 points on 0-10 Likert scale within prior 4 weeks

You may not qualify if:

• Symptomatic urethral stricture Active degenerative/inflammatory neurological disease altering bladder/intestinal function Uncontrolled active autoimmune disease or systemic infection Medical history of pelvic tuberculosis, pelvic radiotherapy or chemotherapy-induced cystitis History of non-cutaneous malignant tumors Current diagnosis of severe psychiatric disorders (major depressive disorder, bipolar disorder, schizophrenia, psychotic disorders) Clinically significant moderate-severe cardiac, pulmonary, hepatic or renal insufficiency Documented hypersensitivity to venlafaxine or other SNRI drugs Concurrent regular use of antibiotics or NSAIDs throughout trial period Pregnancy or breastfeeding state at screening

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Educational Status; Single Person

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)

Socioeconomic Factors; Population Characteristics; Marital Status; Family Characteristics; Demography

Central Study Contacts

Fang Luo FL, doctor

CONTACT

+8615560392365; Litypacop@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Pain Medicine

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07