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Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome (VEN-BPS)

7 juli 2026 uppdaterad av: Fang Luo, Beijing Tiantan Hospital

A Multicenter, Open-label, Observer-blinded Randomized Controlled Trial Comparing the Efficacy and Safety of Venlafaxine Plus Education and Behavioral Modification Program Versus Education and Behavioral Modification Program Alone in Adults With Interstitial Cystitis/Bladder Pain Syndrome

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

140

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Arm 1 Control Arm (n=70)
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.
Beteende: Education and Behavioral Modification Program (EBMP) only
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.
Experimentell: Arm 2 Experimental Arm (n=70)
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.
Läkemedel: Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP)
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient Self-reported Global Response Assessment (GRA)
Tidsram: 12 weeks after randomization
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Visual Analog Scale (VAS) Bladder Pain Score
Tidsram: Baseline, Week 1, Week2, Week6, Week12
0-10 Likert scale; higher scores represent more severe bladder/pelvic discomfort.
Baseline, Week 1, Week2, Week6, Week12
Pelvic Pain and Urgency/Frequency (PUF) Total Score
Tidsram: Baseline, Week 1, Week2, Week6, Week12
8-item scale total score ranging 0-40; higher scores indicate worse pelvic pain and lower urinary tract symptoms.
Baseline, Week 1, Week2, Week6, Week12
O'Leary-Sant ICSI + ICPI Composite Symptom Score
Tidsram: Baseline, Week 1, Week2, Week6, Week12
ICSI (0-20) evaluates frequency, nocturia, urgency and pain; ICPI (0-16) measures symptom-related life interference.
Baseline, Week 1, Week2, Week6, Week12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing Tiantan Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 december 2026

Primärt slutförande (Beräknad)

30 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

7 juli 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

13 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026YJSKTPG

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

The plan for sharing individual participant data (IPD) has not yet been finalized. After trial completion, the research team will evaluate data sharing feasibility under the supervision of the Institutional Review Board, including assessment of participant privacy protection, data de-identification procedures, institutional data management policies and relevant domestic clinical research data regulations. A formal data sharing plan will be formulated and updated to this registry before study results publication.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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