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Control of urinary loss in men undergoing prostate surgery

Effectiveness of integrative and complementary practices associated with pelvic muscle training to control urinary incontinence after radical prostatectomy: randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-3jm5y2
Enrollment
Unknown
Registered
2020-07-24
Start date
2019-04-12
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Urinary incontinence

Interventions

Experimental group I: 30 men who underwent radical prostatectomy with urinary incontinence between 10 and 15 days after the removal of the indwelling bladder catheter, received pelvic floor muscle tra
muscle training associated with systemic acupuncture and muscle training associated with auricular acupuncture) were offered at random, over a period of 2 months and one week (8 sessions / once a week
Device
Behavioural
H02.004
E02.190.044
E02.190.044.133
E02.760.169.063.500.387
E02.190.204
E02.190

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Preserved locomotor, visual, auditory and swallowing capacity; Have a preserved cognitive function, verified by means of a six-item cognitive impairment test; Present urinary incontinence with the need to use at least one or more absorbents daily; Have a loss greater than one gram assessed using the Pad Test; Have removed the delayed bladder catheter within 10 to 15 days

Exclusion criteria

Exclusion criteria: Do not respond to three attempts at contact made by the researcher; Need for readmission; Be in chemotherapy or radiotherapy treatment; Presence of rectum urethral fistula; Presence of urinary incontinence before the surgical procedure; Urinary tract infection (UTI), with urine culture test showing multi-resistant bacteria and more than one cycle of antibiotic therapy; Infection, inflammation or injury to the ear; Allergy to metal or micropore; Not having financial conditions and availability to be at the place of the study; Use of other complementary therapies up to three months prior to the study

Design outcomes

Primary

MeasureTime frame
NNumber of daily pads - Daily Pad Used (evaluated before any treatment and after eight weeks of follow-up - 9th session): the Daily pad used assessment tool consists of counting how many pads the client needs to use during 24 hours. From this quantification, it is possible to classify urinary incontinence as mild (when the client uses one to two liners / absorbents per day), moderate (three absorbents per day) and severe (more than three absorbents per day).;Severity of urinary incontinence - 1 hour pad test (evaluated before any treatment and after eight weeks of follow-up - 9th session): it is a resource that consists of placing an absorbent next to the external urethral meatus, weighed on a scale high sensitivity before and after the end of the test. During the break, the participant is initially instructed to drink 500 milliliters of water and wait for 15 minutes. Then, it is submitted to walking for 30 minutes and a protocol that simulates activities of daily living (15 minutes). At the end of the one hour period, the absorbent is removed, which allows the assessment of urinary loss. The final result of the one hour Pad test allows classification in: continent (losses of up to 1 g); slight loss (between 1.1 and 9.9 g); moderate loss (between 10 to 49.9 g) and severe loss (above 50 g).

Secondary

MeasureTime frame
Severity of urinary incontinence - Urinary Incontinence Scale after Radical Prostatectomy (UISRP) (evaluated before any treatment and after eight weeks of follow-up - 9th session): it is an instrument developed and validated in China in 2010 that assesses urinary incontinence considering radical prostatectomy as its causal factor. It consists of eight items in which the participants must indicate the severity from the five-point Likert scale, in which, zero corresponds to "never" and four to "always". The score ranges from 0 to 32, with higher scores indicating greater severity of urinary incontinence.;Impact of urinary incontinence on Quality of life - “International Consultation on Incontinence Questionnaire - Short Form” (ICIQ-SF) (assessed before any treatment and after eight weeks of follow-up - 9th session): it is a simple, brief questionnaire and self-administered capable of characterizing urinary loss and its impact on the quality of life of patients suffering from urinary incontinence. It consists of six questions: the first two refer to demographic data (age and sex); the next three assess the frequency, severity and impact of urinary incontinence; and the last question consists of a set of eight items related to the causes or situations of urinary incontinence experienced. The total score is obtained by adding the scores of questions three, four and five, with values ranging from zero to 21, considering that the higher the score obtained, the worse the quality of life.;Impact of low urinary tract symptoms on Quality of life - King's Health Questionnaire (KHQ) (assessed before any treatment and after eight weeks of follow-up - 9th session): it is a questionnaire built and validated in English in 1997 with the purpose of evaluating the quality of life of women with urinary incontinence. The KHQ consists of 21 questions, divided into eight domains. Numerical values are assigned to all answers, added and evaluated by domain, therefore there is no general scor

Countries

Brazil

Contacts

Public ContactCissa Azevedo

Universidade Federal de Minas Gerais

cissa.ufsj@gmail.com+5537991287003

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 13, 2026