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

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04437108
Collaborator
(none)
130
1
5
23.9
5.4

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: Li-SWT (suprapubic approach)
  • Procedure: Li-SWT (perineal approach)
  • Procedure: Li-SWT (combined approach)
  • Procedure: Sham treatment
  • Drug: Solifenacin
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Low-intensity Shock Wave Therapy on Persistent Storage Symptoms After Transurethral Surgery for Benign Prostatic Obstruction: A Randomized Controlled Trial
Actual Study Start Date :
Jul 4, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Li-SWT (suprapubic approach)

Patients will be treated by 8 sessions of Li-SWT with one week interval, applied through suprapubic approach.

Procedure: 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.

Active Comparator: Li-SWT (perineal approach)

Patients will be treated by 8 sessions of Li-SWT with one week interval, applied through perineal approach.

Procedure: 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 right and left to 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.

Active Comparator: Li-SWT (combined approach)

Patients will be treated by 8 sessions of Li-SWT with one week interval, applied through suprapubic and perineal approaches during each session.

Procedure: 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 Comparator: Sham treatment

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

Procedure: Sham treatment
The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.

Active Comparator: antimuscarinics

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

Drug: Solifenacin
The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.

Outcome Measures

Primary Outcome Measures

  1. Overactive bladder symptoms score (OABSS) [Data will be analyzed at study completion at approximately 2 years.]

    Change in OABSS (total score = 15) from baseline will be compared every month for 6 months.Overall treatment success is defined as a reduction of ≥ 50% in OABSS.

  2. 3-day voiding diary [Data will be analyzed at study completion at approximately 2 years.]

    Change in daytime frequency (times/24hrs), urgency (times/24hrs), urge incontinence (times/24hrs), nocturia (times/24hrs) and functional bladder capacity (ml) from baseline will be compared every month for 6 months.

  3. Incidence of adverse events associated with treatment [Data will be analyzed at study completion at approximately 2 years.]

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

Secondary Outcome Measures

  1. International index of prostate symptom score (IPSS) [Data will be analyzed at study completion at approximately 2 years.]

    Change in IPSS at 0, 2, 4 and 6 months will be compared.

  2. Post voiding residual urine (PVR) [Data will be analyzed at study completion at approximately 2 years.]

    Change in PVR (ml) at 0, 2, 4 and 6 months will be compared.

  3. Maximum flow rate (Qmax) [Data will be analyzed at study completion at approximately 2 years.]

    Change in Qmax (ml/s) at 0, 2, 4 and 6 months will be compared.

  4. International index of erectile function-15 ( IIEF-15) [Data will be analyzed at study completion at approximately 2 years.]

    Change in IIEF-15) at 0, 2, 4 and 6 months will be compared.

  5. Ejaculatory domain of male sexual health questionnaire (Ej-MSHQ) [Data will be analyzed at study completion at approximately 2 years.]

    Change in Ej-MSHQ at 0, 2, 4 and 6 months will be compared.

  6. Ultrasound measurements of bladder wall thickness (BWT) and detrusor wall thickness (DWT) [Data will be analyzed at study completion at approximately 2 years.]

    Change in ultrasound measurements of BWT and DWT (mm) at 0, 3 and 6 months will be analysed.

  7. Cystometric bladder capacity [Data will be analyzed at study completion at approximately 2 years.]

    Change in cystometric bladder capacity (ml) at 0 and 6 months will be analysed.

  8. Detrusor overactivity [Data will be analyzed at study completion at approximately 2 years.]

    Change in the maximum amplitude (cmH2O) and pattern of detrusor overactivity during cystometry at 0 and 6 months will be analysed.

  9. Detrusor contractility [Data will be analyzed at study completion at approximately 2 years.]

    Change in maximum detrusor pressure (cmH2O) during voiding at 0 and 6 months will be analysed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology and Nephrology center Mansoura Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Mohammed Hegazy, Urology and nephrology center, Mansoura, Egypt
  • Study Chair: Atallah Saaban, Urology and nephrology center, Mansoura, Egypt
  • Study Director: Khaled Sheir, Urology and nephrology center, Mansoura, Egypt
  • Study Director: Ahmed Elshal, Urology and nephrology center, Mansoura, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Hegazy, assistant lecturer of urology, Mansoura University
ClinicalTrials.gov Identifier:
NCT04437108
Other Study ID Numbers:
  • Li-SWT after relief of BPO
First Posted:
Jun 18, 2020
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohammed Hegazy, assistant lecturer of urology, Mansoura University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022