Development of a new penile clamp to prevent urine leakage in men who have urinary incontinence following treatment for prostate cancer

Prostate Cancer UK Continence Management Module 3: Development of an effective and comfortable penile compression device (clamp) Phase 2: Development of a new clamp

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45492194

Enrollment

Registered

2020-03-26

Start date

2018-07-24

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

Prevention of urine leakage in men who have urinary incontinence following treatment for prostate cancer Urological and Genital Diseases

Interventions

This study includes three components: brief testing of early prototypes through an iterative process of user feedback and prototype refinement, laboratory testing of a refined prototype, and user eval

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Urinary incontinence 2. Previous prostate cancer diagnosis 3. Aged 18 years or over 4. Sufficient manual dexterity to apply and release the reference clamp 5. For Group 1, experience of using a penile clamp

Exclusion criteria

Exclusion criteria: 1. Absence of sensation to the penis (self-report) 2. Absence of bladder sensation due to neurological impairment (self-report) 3. Urge incontinence (a strong uncontrollable urge to pass urine and leakage before reaching the toilet) as the predominant urinary symptom (self-report) 4. In the terminal stage of an illness 5. Cognitive impairment (score of <27 on Mini Mental State Exam [MMSE] - to be carried out face-to-face by the research nurse)

Design outcomes

Primary

Measure	Time frame
1. Overall opinion of clamp assessed using Overall Opinion questionnaire after all the clamps have been tested in the user evaluation stage 2. User evaluation assessed using a visual analogue scale (VAS) after all the clamps have been tested in the user evaluation stage 3. Penile blood flow in the intermittent test assessed using circulatory impedance measured using penile laser Doppler Flowmetry (MoorLDI2-IR laser Doppler blood flow imager, Moor Instruments, UK) at baseline, at 10 and 60 min wear-time and at 10 and 30 min after removal of the clamp in the laboratory testing stage 4. Penile blood flow in the continuous test assessed using circulatory impedance measured using penile laser Doppler Flowmetry (MoorLDI2-IR laser Doppler blood flow imager, Moor Instruments, UK) at baseline and 120 min wear-time,at 10, 30, 60 and 120 min after removal of the clamp after the initial wear, and at 120 min after a second application of the clamp and 10 min after the second removal in the laboratory testing stage 5. Interface pressure in the intermittent test assessed using a Talley Mk3 Pressure Monitor (Talley Medical, Romsey, UK) at baseline and after 10 and 60 min wear time 6. Interface pressure in the continuous test assessed using a Talley Mk3 Pressure Monitor (Talley Medical, Romsey, UK) at baseline and after 120 min wear time 7. Inflammatory reaction in penis skin next to the clamp in the intermittent test assessed using analysis of Sebutape (CuDerm Corp., Dallas, TX, US) at 10 and 30 min wear time and 30 min after clamp removal 8. Inflammatory reaction in penis skin next to the clamp in the continuous test assessed using analysis of Sebutape (CuDerm Corp., Dallas, TX, US) at baseline, after 120 minutes wear time, 30, 60 and 120 minutes after initial clamp removal, and 10 min after a second 120-min period of clamp wear 9. Inflammatory response i	—

Measure

Time frame

1. Overall opinion of clamp assessed using Overall Opinion questionnaire after all the clamps have been tested in the user evaluation stage 2. User evaluation assessed using a visual analogue scale (VAS) after all the clamps have been tested in the user evaluation stage 3. Penile blood flow in the intermittent test assessed using circulatory impedance measured using penile laser Doppler Flowmetry (MoorLDI2-IR laser Doppler blood flow imager, Moor Instruments, UK) at baseline, at 10 and 60 min wear-time and at 10 and 30 min after removal of the clamp in the laboratory testing stage 4. Penile blood flow in the continuous test assessed using circulatory impedance measured using penile laser Doppler Flowmetry (MoorLDI2-IR laser Doppler blood flow imager, Moor Instruments, UK) at baseline and 120 min wear-time,at 10, 30, 60 and 120 min after removal of the clamp after the initial wear, and at 120 min after a second application of the clamp and 10 min after the second removal in the laboratory testing stage 5. Interface pressure in the intermittent test assessed using a Talley Mk3 Pressure Monitor (Talley Medical, Romsey, UK) at baseline and after 10 and 60 min wear time 6. Interface pressure in the continuous test assessed using a Talley Mk3 Pressure Monitor (Talley Medical, Romsey, UK) at baseline and after 120 min wear time 7. Inflammatory reaction in penis skin next to the clamp in the intermittent test assessed using analysis of Sebutape (CuDerm Corp., Dallas, TX, US) at 10 and 30 min wear time and 30 min after clamp removal 8. Inflammatory reaction in penis skin next to the clamp in the continuous test assessed using analysis of Sebutape (CuDerm Corp., Dallas, TX, US) at baseline, after 120 minutes wear time, 30, 60 and 120 minutes after initial clamp removal, and 10 min after a second 120-min period of clamp wear 9. Inflammatory response i

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Secondary

Measure	Time frame
1. Leakage performance assessed using the Pad Leakage Diary prior to wearing the clamp for 2 hours and whilst wearing the pad for 2 hours on three occasions during the 2-week user evaluation of each clamp 2. Comfort assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 3. Reliability assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 4. Pain assessed using a visual analogue score (VAS) in the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 5. Ease of use assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 6. Discreetness assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 7. Ease of cleaning the clamp assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 8. Product preference as a measure of performance against the reference clamp using the Clamp Product Preference Questionnaire after all clamps have been tested in the user evaluation	—

Measure

Time frame

1. Leakage performance assessed using the Pad Leakage Diary prior to wearing the clamp for 2 hours and whilst wearing the pad for 2 hours on three occasions during the 2-week user evaluation of each clamp 2. Comfort assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 3. Reliability assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 4. Pain assessed using a visual analogue score (VAS) in the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 5. Ease of use assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 6. Discreetness assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 7. Ease of cleaning the clamp assessed using the Clamp Product Performance Questionnaire after the 2-week user evaluation of each clamp 8. Product preference as a measure of performance against the reference clamp using the Clamp Product Preference Questionnaire after all clamps have been tested in the user evaluation

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026