Overactive BladderNCT04437108
Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO
A study testing Li-SWT (suprapubic approach), Li-SWT (perineal approach) and Li-SWT (combined approach) in people with Overactive Bladder and Urinary Incontinence, Urge, run by Mansoura University at 1 site in Egypt.
Trial summary
comparing the outcome of low-intensity shock wave therapy (Li-SWT) versus solifenacin on persistent storage symptoms after transurethral surgery for benign prostatic obstruction (BPO) Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence, Urge, Urgency-frequency Syndrome
- What is being tested?
- Li-SWT (suprapubic approach), Li-SWT (perineal approach) and Li-SWT (combined approach)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jul 2020to 21 Jul 2022
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have to fulfill all the following criteria to be included in the study:
- Ability to give informed consent and reply to questionnaires.
- Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary.
- Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy.
Who cannot join
- Patients who have any of the following will be excluded from the study:
- Untreated UTI.
- BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture.
- Neurogenic lower urinary tract dysfunction (LUTD).
- Uncontrolled diabetes mellitus.
- Depression or any psychogenic disorders.
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- Prior radiation therapy to the pelvic area.
- History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy.
- Poor coagulopathy.
- Severe cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial
comparing the outcome of low-intensity shock wave therapy (Li-SWT) versus solifenacin on persistent storage symptoms after transurethral surgery for benign prostatic obstruction (BPO)
Read the detailed description
Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in aging men including both voiding and storage symptoms. After prostatectomy, 20-30% of the patients still have persistent storage symptoms. The pathophysiology of persistent storage symptoms after surgical relief of benign prostatic obstruction (BPO) remains unclear. It may be due to bladder changes produced by long standing bladder outlet obstruction (BOO) including bladder ischemia and denervation or it may be related to other factors rather than preoperative BOO such as aging, chronic inflammation or a subtle neurological disorder.
After exclusion of urinary tract infection (UTI) and BOO, antimuscarinics are the commonly used medications for post-prostatectomy persistent storage symptoms. However, these medications are associated with side effects which may interfere with the patient compliance.
Low-intensity shock wave therapy (Li-SWT) is a non invasive procedure that has a beneficial effect in promoting revascularization and enhancing tissue regeneration. It has been applied to the penis for erectile dysfunction and to the perineum for chronic pelvic pain syndrome (CPPS) with encouraging results. In a rat model, it has been reported that defocused Li-SWT leads to improvement of bladder innervation and vascularization.
Based on the previously mentioned studies, the investigators hypothesized that Li-SWT can offer benefit in improvement of persistent storage symptoms after surgical relief of BPO. In the present study, the investigators will evaluate the effect of Li-SWT on persistent storage symptoms after transurethral surgery for BPO compared to antimuscarinics in a randomized controlled trial (RCT).
- Conditions
- Overactive Bladder, Urinary Incontinence, Urge, Urgency-frequency Syndrome, Post Prostatectomy
- Being tested
- Li-SWT (suprapubic approach), Li-SWT (perineal approach), Li-SWT (combined approach), Sham treatment, Solifenacin
- Keywords
- low-intensity shock wave therapy, persistent storage symptoms, benign prostatic obstruction
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Li-SWT (suprapubic approach)Procedure or surgery
The patient will be asked to lie in flat dorsal position. A commercially used gel for sonography will be applied to the suprapubic region. The applicator will be placed on suprapubic region with two fingers apart from the symphysis pubis tilting to 45°. Shock waves will be directed to 3 different sites; the midline (over the bladder dome) and 3 cm right and left to the midline (over bilateral bladder walls). The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.
Li-SWT (perineal approach)Procedure or surgery
The patient will be asked to lie in lithotomy position. A commercially used gel for sonography will be applied to the perineum. The applicator will be placed on perineal region. Shock waves will be directed to 3 different sites: the midline and 2 cm above and below the midline. The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.
Li-SWT (combined approach)Procedure or surgery
The patient will receive 3000 shocks; 1500 shocks through suprapubic approach (500 shocks per site) and another 1500 shocks through perineal approach (500 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.
Sham treatmentProcedure or surgery
The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.
SolifenacinDrug
The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Li-SWT | Active comparator | Patients will be treated by 8 sessions of Li-SWT with one week interval. This group is subdivided into 3 subgroups according to the approach through which Li-SWT is applied; suprapubic, perineal and combined approaches Receives: Procedure: Li-SWT (suprapubic approach); Procedure: Li-SWT (perineal approach); Procedure: Li-SWT (combined approach) |
| Sham treatment | Sham comparator | Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches. Receives: Procedure: Sham treatment |
| antimuscarinics | Active comparator | Patients will be treated by solifenacin 10 mg once daily for 6 months. Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in overactive bladder symptoms score (OABSS)
The primary endpoint is the percent change from baseline in the total score of OABSS (total score = 15) at 3-month follow up.
Measured: approximately 20 months
Percent of responders
The percent of responders at 3-month follow up. Three points reduction in the total score of OABSS is determined as the minimal threshold for a meaningful change. Responders are defined as patients who achieved reduction in the total score of OABSS ≥ 3 at 3-month follow up, and those patients will continue on the same treatment modality.
Measured: approximately 20 months
The numerical change in overactive bladder symptoms score (OABSS)
The numerical change from baseline in the total score and sub-scores of OABSS at 3 and 6-month follow up will be reported.
Measured: approximately 2 years.
3-day voiding diary
Change in daytime frequency (times/24hrs), urgency (times/24hrs), urge incontinence (times/24hrs), nocturia (times/24hrs) and average voided volume/micturition (ml) from baseline will be compared at 3 and 6-month follow up.
Measured: approximately 2 years.
Incidence of adverse events associated with treatment
Incidence of adverse events associated with Li-SWT or solifenacin (n%) should be reported.
Measured: approximately 18 months
Secondary outcomes (7)
International index of prostate symptom score (IPSS)
Change in IPSS at 0, 3 and 6 months will be compared.
Measured: approximately 2 years.
Post voiding residual urine (PVR)
Change in PVR (ml) at 0, 3 and 6 months will be compared.
Measured: approximately 2 years.
Maximum flow rate (Qmax)
Change in Qmax (ml/s) at 0, 3 and 6 months will be compared.
Measured: approximately 2 years.
International index of erectile function-15 ( IIEF-15)
Change in IIEF-15) at 0, 3 and 6 months will be compared.
Measured: approximately 2 years.
Cystometric bladder capacity
Change in bladder volume (ml) at first sensation of filling and maximum cystometric capacity (ml) at 0 and 6 months will be analysed.
Measured: approximately 2 years.
Detrusor overactivity
Change in detrusor stability and maximum amplitude (cmH2O) of detrusor overactivity during cystometry at 0 and 6 months will be analysed.
Measured: approximately 2 years.
Detrusor contractility
Change in maximum detrusor pressure (cmH2O) and BCI during voiding at 0 and 6 months will be analysed.
Measured: approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start4 Jul 2020
- Primary completion12 Apr 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Mohamed Elshal
- Responsible party
- Principal investigator, Mohammed Hegazy, Mansoura University
- Investigators
- Mohammed Hegazy, Principal investigator, Urology and nephrology center, Mansoura, EgyptMohamed Gaballah, Study director, Urology and nephrology center, Mansoura, EgyptKhaled Sheir, Study director, Urology and nephrology center, Mansoura, EgyptAhmed Elshal, Study director, Urology and nephrology center, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437108
- Sponsor's protocol ID
- Li-SWT after relief of BPO
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04437108
- Acronym / sponsor ID
- Li-SWT after relief of BPO
- Conditions
- Overactive Bladder, Urinary Incontinence, Urge, Urgency-frequency Syndrome, Post Prostatectomy
- Keywords
- low-intensity shock wave therapy, persistent storage symptoms, benign prostatic obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Ahmed Mohamed Elshal
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 18 Jun 2020 (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.
comparing the outcome of low-intensity shock wave therapy (Li-SWT) versus solifenacin on persistent storage symptoms after transurethral surgery for benign prostatic obstruction (BPO)
Detailed description
Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in aging men including both voiding and storage symptoms. After prostatectomy, 20-30% of the patients still have persistent storage symptoms. The pathophysiology of persistent storage symptoms after surgical relief of benign prostatic obstruction (BPO) remains unclear. It may be due to bladder changes produced by long standing bladder outlet obstruction (BOO) including bladder ischemia and denervation or it may be related to other factors rather than preoperative BOO such as aging, chronic inflammation or a subtle neurological disorder.
After exclusion of urinary tract infection (UTI) and BOO, antimuscarinics are the commonly used medications for post-prostatectomy persistent storage symptoms. However, these medications are associated with side effects which may interfere with the patient compliance.
Low-intensity shock wave therapy (Li-SWT) is a non invasive procedure that has a beneficial effect in promoting revascularization and enhancing tissue regeneration. It has been applied to the penis for erectile dysfunction and to the perineum for chronic pelvic pain syndrome (CPPS) with encouraging results. In a rat model, it has been reported that defocused Li-SWT leads to improvement of bladder innervation and vascularization.
Based on the previously mentioned studies, the investigators hypothesized that Li-SWT can offer benefit in improvement of persistent storage symptoms after surgical relief of BPO. In the present study, the investigators will evaluate the effect of Li-SWT on persistent storage symptoms after transurethral surgery for BPO compared to antimuscarinics in a randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Li-SWT | Active comparator | Procedure: Li-SWT (suprapubic approach), Procedure: Li-SWT (perineal approach), Procedure: Li-SWT (combined approach)Patients will be treated by 8 sessions of Li-SWT with one week interval. This group is subdivided into 3 subgroups according to the approach through which Li-SWT is applied; suprapubic, perineal and combined approaches |
| Sham treatment | Sham comparator | Procedure: Sham treatmentPatients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches. |
| antimuscarinics | Active comparator | Drug: SolifenacinPatients will be treated by solifenacin 10 mg once daily for 6 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have to fulfill all the following criteria to be included in the study:
Key exclusion criteria (10 listed)
- Patients who have any of the following will be excluded from the study:
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 |
|---|---|---|
| Li-SWT (suprapubic approach)The patient will be asked to lie in flat dorsal position. A commercially used gel for sonography will be applied to the suprapubic region. The applicator will be placed on suprapubic region with two fingers apart from the symphysis pubis tilting to 45°. Shock waves will be directed to 3 different sites; the midline (over the bladder dome) and 3 cm right and left to the midline (over bilateral bladder walls). The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz. | Procedure or surgery | Li-SWT |
| Li-SWT (perineal approach)The patient will be asked to lie in lithotomy position. A commercially used gel for sonography will be applied to the perineum. The applicator will be placed on perineal region. Shock waves will be directed to 3 different sites: the midline and 2 cm above and below the midline. The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz. | Procedure or surgery | Li-SWT |
| Li-SWT (combined approach)The patient will receive 3000 shocks; 1500 shocks through suprapubic approach (500 shocks per site) and another 1500 shocks through perineal approach (500 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz. | Procedure or surgery | Li-SWT |
| Sham treatmentThe same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off. | Procedure or surgery | Sham treatment |
| SolifenacinThe patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy. | Drug | antimuscarinics |
Primary outcome
The percent change in overactive bladder symptoms score (OABSS)
Time frame: approximately 20 months
The primary endpoint is the percent change from baseline in the total score of OABSS (total score = 15) at 3-month follow up.
Percent of responders
Time frame: approximately 20 months
The percent of responders at 3-month follow up. Three points reduction in the total score of OABSS is determined as the minimal threshold for a meaningful change. Responders are defined as patients who achieved reduction in the total score of OABSS ≥ 3 at 3-month follow up, and those patients will continue on the same treatment modality.
The numerical change in overactive bladder symptoms score (OABSS)
Time frame: approximately 2 years.
The numerical change from baseline in the total score and sub-scores of OABSS at 3 and 6-month follow up will be reported.
3-day voiding diary
Time frame: approximately 2 years.
Change in daytime frequency (times/24hrs), urgency (times/24hrs), urge incontinence (times/24hrs), nocturia (times/24hrs) and average voided volume/micturition (ml) from baseline will be compared at 3 and 6-month follow up.
Incidence of adverse events associated with treatment
Time frame: approximately 18 months
Incidence of adverse events associated with Li-SWT or solifenacin (n%) should be reported.
7 secondary outcomes
International index of prostate symptom score (IPSS)
Time frame: approximately 2 years.
Post voiding residual urine (PVR)
Time frame: approximately 2 years.
Maximum flow rate (Qmax)
Time frame: approximately 2 years.
International index of erectile function-15 ( IIEF-15)
Time frame: approximately 2 years.
Cystometric bladder capacity
Time frame: approximately 2 years.
Detrusor overactivity
Time frame: approximately 2 years.
Detrusor contractility
Time frame: approximately 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
Mohammed Hegazy principal investigator
Urology and nephrology center, Mansoura, Egypt
Mohamed Gaballah study director
Urology and nephrology center, Mansoura, Egypt
Khaled Sheir study director
Urology and nephrology center, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Li-SWT (suprapubic approach), Li-SWT (perineal approach) and Li-SWT (combined approach) in people with Overactive Bladder and Urinary Incontinence, Urge, run by Mansoura University 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jun 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percent change in overactive bladder symptoms score (OABSS) (time frame: approximately 20 months). The study lists 5 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 15 Jun 2023.