Lower urinary tract symptoms (LUTS) in older men. The FLOW study.

Pelvic floor exercises compared to medication in the treatment of older men with lower urinary tract symptoms (LUTS) in general practice. The FLOW study. A pilot.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25307

Enrollment

Registered

2011-06-28

Start date

2011-06-20

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

LUTS, lower urinary tract symptoms, Pelvic floor dysfunction, Pelvic floor muscle training, Pelvic floor physiotherapy, alpha1-bockers, Symptoms of the lower urinary tract, slow urine stream, hesitation, urgency, nocturia and post void dribble, general practitioner, male patients, prostate incontinence. Plasklachten, bekkenbodem, bekkenbodemspieren, fysiotherapie, bekkenbodemfysiotherapie, prostaat, man, incontinentie

Interventions

Pelvic floor physiotherapy group: In the physiotherapy group, patients will be referred to a specialized physiotherapist. This physiotherapist has done a 2 years training on pelvic floor problems, af

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 50 years or older; 2. LUTS symptoms, operationalised as an IPSS score of 8 and higher (range of the IPSS score is 0-35: ≤ 7 representsmild symptoms, 8-19 moderate symptoms and 20-35 severe symptoms) for more than 6 months; 3. Interpretable flow (minimal production of 100 ml of urine); 4. No treatment for LUTS in the preceding 6 months; 5. No urinary tract infection or neurological bladder disorders; 6. No urological malignancy or surgery of prostate, bladder, anus, pelvic floor; 7. No indwelling catheter or intermittent catheterization; 8. Being able to visit a pelvic floor physiotherapist or to fill in questionnaires in Dutch; 9. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Terminal stage of disease (according to the general practitioner); 2. Psychiatric or cognitive disorders (according to the general practitioner); 3. Contra-indication for prescribing ¦Á1-blocking agents (according to the general practitioner and checked by the investigator); 4. Abnormal prostate gland as found by digital rectal examination.

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter is the change in lower urinary tract symptom score as measured with the International Prostate Symptom Scale (IPSS), a validated instrument to assess symptoms and bother caused by LUTS.	—

Secondary

Measure	Time frame
Secondary outcome measures are the mean and maximum flow, as measured with free uroflowmetry, sexual functioning measured with the MLUTSsex questionnaire, quality of life, as measured with a quality of life question added to the IPSS (condition specific) and with the EQ-5D (generic quality of life) and global perception of improvement (GPI).	—

Contacts

Public ContactJan Hut

Afd. Huisartsgeneeskunde UMCG Postbus 196/ HPC: FA 21

j.hut@med.umcg.nl+31 (0)6 14145779

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)