Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO
NCT ID: NCT04437108
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2020-07-04
2022-07-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Li-SWT
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
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.
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.
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.
Sham treatment
Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches.
Sham treatment
The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.
antimuscarinics
Patients will be treated by solifenacin 10 mg once daily for 6 months.
Solifenacin
The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.
Interventions
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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.
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.
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.
Sham treatment
The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.
Solifenacin
The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.
Eligibility Criteria
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Inclusion Criteria
1. Ability to give informed consent and reply to questionnaires.
2. Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary.
3. Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy.
Exclusion Criteria
1. Untreated UTI.
2. BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture.
3. Neurogenic lower urinary tract dysfunction (LUTD).
4. Uncontrolled diabetes mellitus.
5. Depression or any psychogenic disorders.
6. Prior radiation therapy to the pelvic area.
7. History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy.
8. Poor coagulopathy.
9. Severe cardiovascular disease.
50 Years
MALE
No
Sponsors
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Ahmed Mohamed Elshal
UNKNOWN
Mansoura University
OTHER
Responsible Party
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Mohammed Hegazy
assistant lecturer of urology
Principal Investigators
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Mohammed Hegazy
Role: PRINCIPAL_INVESTIGATOR
Urology and nephrology center, Mansoura, Egypt
Mohamed Gaballah
Role: STUDY_DIRECTOR
Urology and nephrology center, Mansoura, Egypt
Khaled Sheir
Role: STUDY_DIRECTOR
Urology and nephrology center, Mansoura, Egypt
Ahmed Elshal
Role: STUDY_DIRECTOR
Urology and nephrology center, Mansoura, Egypt
Locations
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Urology and Nephrology center
Al Mansurah, , Egypt
Countries
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Other Identifiers
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Li-SWT after relief of BPO
Identifier Type: -
Identifier Source: org_study_id
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