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

NCT04437108 | Completed DMC

• 1 other identifier: Li-SWT after relief of BPO
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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)

Conditions

Overactive Bladder; Urinary Incontinence, Urge; Urgency-frequency Syndrome; Post Prostatectomy

Keywords

low-intensity shock wave therapy; persistent storage symptoms; benign prostatic obstruction

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  approximately 2 years.

• Incidence of adverse events associated with treatment

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

  approximately 18 months

Secondary Outcomes (7)

• International index of prostate symptom score (IPSS)

  approximately 2 years.

• Post voiding residual urine (PVR)

  approximately 2 years.

• Maximum flow rate (Qmax)

  approximately 2 years.

• International index of erectile function-15 ( IIEF-15)

  approximately 2 years.

• Cystometric bladder capacity

  approximately 2 years.

Study Arms (3)

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

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.

Procedure: Sham treatment

antimuscarinics

ACTIVE COMPARATOR

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

Drug: Solifenacin

Interventions

Li-SWT (suprapubic approach) PROCEDURE

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

Li-SWT (perineal approach) PROCEDURE

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

Li-SWT (combined approach) PROCEDURE

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.

Li-SWT

Sham treatment PROCEDURE

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

Sham treatment

Solifenacin DRUG

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

antimuscarinics

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Patients suffering from persistent storage symptoms ≥ 3 months following any transurethral surgery for BPO will be asked to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead
• Ahmed Mohamed Elshal: collaborator

Study Sites (1)

Urology and Nephrology center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mohammed Hegazy

  Urology and nephrology center, Mansoura, Egypt

  PRINCIPAL INVESTIGATOR

• Mohamed Gaballah

  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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of urology

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 18, 2020
• Study Start: July 4, 2020
• Primary Completion: April 12, 2022
• Study Completion: July 21, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

EG (1)