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The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial

The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial - The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035734
Enrollment
15
Registered
2019-02-01
Start date
2019-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder

Interventions

Combination with behavioral and psychological therapy for drug-resistant overactive bladder (30 minutes/ session, once a week, total 6 sessions)

Sponsors

Department of Urology, Kyoto University, Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as OAB and receiving pharmacological therapy for more than 12 weeks. 2. Participants remains OAB symptom, the total point of overactive bladder symptom score (OABSS) is more than 6 points (moderate or more). 3. Fully active, able to carry on all pre-disease performance without restriction (ECOG Performance Status: Grade 0). 4. Participants who understand explanation and obtain written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants has abnormality around the bladder (e.g., bladder stone, urethral stone, interstitial cystitis, endometriosis, pelvic organ prolapse). 2. Participant is diagnosed as Urinary Tract Infection (UTI). 3. Participants who have had surgery for urinary incontinence. 4. Pregnant or possibly pregnant participants. 5. Participants who can not understand the notation of Japanese. 6. Participants with anxiety/ depressed tendency (Hospitality Anxiety and Depression Scale (HADS) is more than 21 point). 7. Participants who are diagnosed as dementia. 8. Participants who are considered as inappropriate for this study by the responsible doctor

Design outcomes

Primary

MeasureTime frame
1. Drop out rate 2. Overactive bladder questionnaire (OAB-q)

Secondary

MeasureTime frame
1. Overactive bladder symptom score (OABSS) 2. King's health questionnaire (KHQ) 3. Global Improvement Scale (GIS) 4. Euroqol-5D-5L (EQ-5D-5L) 5. Hospital Anxiety and Depression Scale (HADS) 6. Frequency volume chart 7. Participant satisfaction 8. Change of drug therapy 9. Adverse events 10. Participant feedback

Countries

Japan

Contacts

Public ContactSatoshi Funada

Kyoto University, Graduate School of Medicine Urology

sfunada@kuhp.kyoto-u.ac.jp075-751-3337

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026