Stress Incontinence, MaleIncontinenceNCT06322082
Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence
A study testing The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) in people with Stress Incontinence, Male, run by Khadra Mohamed Ali at 1 site in Egypt.
Trial summary
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Stress Incontinence, Male
- What is being tested?
- The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed as urinary incontinence.
- Age between 40 -75 male patients or older.
- All patients received the same medical treatment
Who cannot join
- adjuvant or neoadjuvant chemo-radiation therapy.
- severe postoperative complications.
- history of pelvic surgery, and diseases that could affect voiding function and limitations for the exercise program such as for patients with serious cardiovascular events or spinal or articular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilates Training Combined With Low Intensity Shock Wave Therapy on Post-prostatectomy Stress Incontinence: Randomized Controlled Trial
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment.
Read the detailed description
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence by Urodynamic investigation system, Severity index scale and Cytometry and quality of life by The quality of life questionnaire IQOL after three months from treatment.
- Conditions
- Stress Incontinence, Male
- Being tested
- The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)Device
Also called Pilates exercises, conventional pelvic floor muscle exercises
The LiESWT was applied to Pilates and Shock Wave group and Shock Wave group with 0.25 mJ/mm2 of intensity, 3000 pulses of shock, and 3 pulses/s of frequency, applicator was placed on the suprapubic skin area one session in the week for twelve weeks, totaling 12 sessions.
Pilates exercises were performed to Pilates and Shock Wave group and Pilates group. The sessions of Pilates were applied twice a week for twelve weeks, totaling 24 sessions. The 50 min Pilates sessions were divided into three phases: warm-up, strengthening, and stretching. They also received written orientations to perform three exercises and two of the Pilates session at home every day - Conventional pelvic floor exercises performed for all groups include Kegel exercise, squats, bridging, and squeeze and release exercises. These exercises were performed 3 times per day, lasting for 12 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Pilates and Shock Wave group | Experimental | 30 patients will receive Pilates exercises combined with Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises Receives: Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) |
| Shock Wave group | Experimental | 30 patients will receive Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises. Receives: Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) |
| Pilates group | Experimental | 30 patients will receive Pilates exercises and conventional pelvic floor muscle exercises Receives: Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) |
| control group | Experimental | 30 patients will receive conventional pelvic floor muscle exercises Receives: Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystometry
Ithe dynamic measurement of detrusor pressure during the continuous filling of the bladder.
Measured: before treatment and after 3 months
Severity index scale
measure frequency and amount of urine loss ,calculated by this equation: Severity index of incontinence = (Points for frequency of urine loss) × (Points for amount of urine loss) calculated by this equation: Severity index of incontinence = (Points for frequency of urine loss) × (Points for amount of urine loss) measure frequency and amount of urine loss to calculate severity of incontinence, o Frequency of urine loss grades: Never = 0 less than once a month= 1 once to several times a month = 2 once to several times a week = 3 Every day and/or night = 4
- o Amount of urine loss grades: No drop (completely dry) = 0 A few drops = 1 A little = 2 More = 3
Measured: before treatment and after 3 months
Secondary outcomes (1)
body mass index
measure ( weight per height squares )of patients kg/m^2
Measured: before treatment and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start20 Mar 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khadra Mohamed Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Khadra Mohamed Ali, Cairo University
- Investigators
- Marwa Eid, Principal investigator, Professor at Faculty of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322082
- Sponsor's protocol ID
- 1422024
- Acronym
- Incontinence
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 120 male Patients with urinary incontinence would be randomly assigned to 4 groups all receive conventional pelvic floor exercises(CPFE) plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy (LiECSWT), group B receive (LiECSWT), group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises only. (LiECSWT) was applied with 0.25 mJ/mm2 of intensity, 3000 pulses of shock, and 3 pulses/s of frequency, one session in the week for twelve weeks. Pilates exercises twice a week for twelve weeks, totaling 24 sessions and (CPFE) were performed 3 times per day, lasting for 12 consecutive weeks. Assessment at baseline, immediately after the intervention, by Urodynamic investigation system, Severity index scale, Cytometry and The quality of life questionnaire IQOL.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Training Combined With Low Intensity Shock Wave Therapy on Post-prostatectomy Stress Incontinence: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06322082
- Acronym / sponsor ID
- Incontinence / 1422024
- Conditions
- Stress Incontinence, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Khadra Mohamed AliUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment.
Detailed description
120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence by Urodynamic investigation system, Severity index scale and Cytometry and quality of life by The quality of life questionnaire IQOL after three months from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilates and Shock Wave group | Experimental | Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)30 patients will receive Pilates exercises combined with Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises |
| Shock Wave group | Experimental | Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)30 patients will receive Low Intensity Extracorporeal Shock Wave Therapy and conventional pelvic floor muscle exercises. |
| Pilates group | Experimental | Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)30 patients will receive Pilates exercises and conventional pelvic floor muscle exercises |
| control group | Experimental | Device: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)30 patients will receive conventional pelvic floor muscle exercises |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients diagnosed as urinary incontinence.
- Age between 40 -75 male patients or older.
- All patients received the same medical treatment
Key exclusion criteria (3 listed)
- adjuvant or neoadjuvant chemo-radiation therapy.
- severe postoperative complications.
- history of pelvic surgery, and diseases that could affect voiding function and limitations for the exercise program such as for patients with serious cardiovascular events or spinal or articular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG)Also: Pilates exercises, conventional pelvic floor muscle exercisesThe LiESWT was applied to Pilates and Shock Wave group and Shock Wave group with 0.25 mJ/mm2 of intensity, 3000 pulses of shock, and 3 pulses/s of frequency, applicator was placed on the suprapubic skin area one session in the week for twelve weeks, totaling 12 sessions. Pilates exercises were performed to Pilates and Shock Wave group and Pilates group. The sessions of Pilates were applied twice a week for twelve weeks, totaling 24 sessions. The 50 min Pilates sessions were divided into three phases: warm-up, strengthening, and stretching. They also received written orientations to perform three exercises and two of the Pilates session at home every day - Conventional pelvic floor exercises performed for all groups include Kegel exercise, squats, bridging, and squeeze and release exercises. These exercises were performed 3 times per day, lasting for 12 consecutive weeks | Device | Pilates and Shock Wave group, Pilates group, Shock Wave group, control group |
Primary outcome
Cystometry
Time frame: before treatment and after 3 months
Ithe dynamic measurement of detrusor pressure during the continuous filling of the bladder.
Severity index scale
Time frame: before treatment and after 3 months
measure frequency and amount of urine loss ,calculated by this equation: Severity index of incontinence = (Points for frequency of urine loss) × (Points for amount of urine loss) calculated by this equation: Severity index of incontinence = (Points for frequency of urine loss) × (Points for amount of urine loss) measure frequency and amount of urine loss to calculate severity of incontinence, o Frequency of urine loss grades: Never = 0 less than once a month= 1 once to several times a month = 2 once to several times a week = 3 Every day and/or night = 4 * o Amount of urine loss grades: No drop (completely dry) = 0 A few drops = 1 A little = 2 More = 3
1 secondary outcome
body mass index
Time frame: before treatment and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Yes. 120 male Patients with urinary incontinence would be randomly assigned to 4 groups all receive conventional pelvic floor exercises(CPFE) plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy (LiECSWT), group B receive (LiECSWT), group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises only. (LiECSWT) was applied with 0.25 mJ/mm2 of intensity, 3000 pulses of shock, and 3 pulses/s of frequency, one session in the week for twelve weeks. Pilates exercises twice a week for twelve weeks, totaling 24 sessions and (CPFE) were performed 3 times per day, lasting for 12 consecutive weeks. Assessment at baseline, immediately after the intervention, by Urodynamic investigation system, Severity index scale, Cytometry and The quality of life questionnaire IQOL.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Eid principal investigator
Professor at Faculty of physical therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG) in people with Stress Incontinence, Male, run by Khadra Mohamed Ali at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystometry (time frame: before treatment and after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.