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Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO

Primary Purpose

Overactive Bladder, Urinary Incontinence, Urge, Urgency-frequency Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Li-SWT (suprapubic approach)
Li-SWT (perineal approach)
Li-SWT (combined approach)
Sham treatment
Solifenacin
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring low-intensity shock wave therapy, persistent storage symptoms, benign prostatic obstruction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients have to fulfill all the following criteria to be included in the study:

    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:

  • Patients who have any of the following will be excluded from the study:

    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.

Sites / Locations

  • Urology and Nephrology center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Li-SWT

Sham treatment

antimuscarinics

Arm Description

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

Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches.

Patients will be treated by solifenacin 10 mg once daily for 6 months.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Incidence of adverse events associated with treatment
Incidence of adverse events associated with Li-SWT or solifenacin (n%) should be reported.

Secondary Outcome Measures

International index of prostate symptom score (IPSS)
Change in IPSS at 0, 3 and 6 months will be compared.
Post voiding residual urine (PVR)
Change in PVR (ml) at 0, 3 and 6 months will be compared.
Maximum flow rate (Qmax)
Change in Qmax (ml/s) at 0, 3 and 6 months will be compared.
International index of erectile function-15 ( IIEF-15)
Change in IIEF-15) at 0, 3 and 6 months will be compared.
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.
Detrusor overactivity
Change in detrusor stability and maximum amplitude (cmH2O) of detrusor overactivity during cystometry at 0 and 6 months will be analysed.
Detrusor contractility
Change in maximum detrusor pressure (cmH2O) and BCI during voiding at 0 and 6 months will be analysed.

Full Information

First Posted
June 11, 2020
Last Updated
June 12, 2023
Sponsor
Mansoura University
Collaborators
Ahmed Mohamed Elshal
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1. Study Identification

Unique Protocol Identification Number
NCT04437108
Brief Title
Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO
Official Title
Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 4, 2020 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
July 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
Ahmed Mohamed Elshal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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)
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence, Urge, Urgency-frequency Syndrome, Post Prostatectomy
Keywords
low-intensity shock wave therapy, persistent storage symptoms, benign prostatic obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Li-SWT
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Patients will be treated by 8 sessions of sham treatment with one week interval, applied through suprapubic and perineal approaches.
Arm Title
antimuscarinics
Arm Type
Active Comparator
Arm Description
Patients will be treated by solifenacin 10 mg once daily for 6 months.
Intervention Type
Procedure
Intervention Name(s)
Li-SWT (suprapubic approach)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Li-SWT (perineal approach)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Li-SWT (combined approach)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham treatment
Intervention Description
The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Intervention Description
The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.
Primary Outcome Measure Information:
Title
The percent change in overactive bladder symptoms score (OABSS)
Description
The primary endpoint is the percent change from baseline in the total score of OABSS (total score = 15) at 3-month follow up.
Time Frame
approximately 20 months
Title
Percent of responders
Description
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.
Time Frame
approximately 20 months
Title
The numerical change in overactive bladder symptoms score (OABSS)
Description
The numerical change from baseline in the total score and sub-scores of OABSS at 3 and 6-month follow up will be reported.
Time Frame
approximately 2 years.
Title
3-day voiding diary
Description
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.
Time Frame
approximately 2 years.
Title
Incidence of adverse events associated with treatment
Description
Incidence of adverse events associated with Li-SWT or solifenacin (n%) should be reported.
Time Frame
approximately 18 months
Secondary Outcome Measure Information:
Title
International index of prostate symptom score (IPSS)
Description
Change in IPSS at 0, 3 and 6 months will be compared.
Time Frame
approximately 2 years.
Title
Post voiding residual urine (PVR)
Description
Change in PVR (ml) at 0, 3 and 6 months will be compared.
Time Frame
approximately 2 years.
Title
Maximum flow rate (Qmax)
Description
Change in Qmax (ml/s) at 0, 3 and 6 months will be compared.
Time Frame
approximately 2 years.
Title
International index of erectile function-15 ( IIEF-15)
Description
Change in IIEF-15) at 0, 3 and 6 months will be compared.
Time Frame
approximately 2 years.
Title
Cystometric bladder capacity
Description
Change in bladder volume (ml) at first sensation of filling and maximum cystometric capacity (ml) at 0 and 6 months will be analysed.
Time Frame
approximately 2 years.
Title
Detrusor overactivity
Description
Change in detrusor stability and maximum amplitude (cmH2O) of detrusor overactivity during cystometry at 0 and 6 months will be analysed.
Time Frame
approximately 2 years.
Title
Detrusor contractility
Description
Change in maximum detrusor pressure (cmH2O) and BCI during voiding at 0 and 6 months will be analysed.
Time Frame
approximately 2 years.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patients suffering from persistent storage symptoms ≥ 3 months following any transurethral surgery for BPO will be asked to participate in this study.
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Hegazy
Organizational Affiliation
Urology and nephrology center, Mansoura, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Gaballah
Organizational Affiliation
Urology and nephrology center, Mansoura, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khaled Sheir
Organizational Affiliation
Urology and nephrology center, Mansoura, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Elshal
Organizational Affiliation
Urology and nephrology center, Mansoura, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Urology and Nephrology center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO

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