Clinical trial NCT06130306: A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI
Official title: Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence: A Propensity Score Matching Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence Following Surgical Procedure
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong Hospital of Traditional Chinese Medicine
First posted: 2023-11-14
Enrollment: 389
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged between 18-80 with post-radical prostatectomy incontinence treated at 3 tertiary academic medical centers between 2012 and 2020 were retrieved.

Brief summary: The goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation.

Detailed description: Prostate cancer is the predominant form of cancer in older males. Radical prostatectomy (RP) is the sole treatment that enhances both overall survival and cancer-specific survival.Urinary incontinence remains a major morbidity associated with this procedure, greatly affecting patient satisfaction following RP. Extant research underscores the efficacy of pelvic floor muscle training (PFMT) in improving the strength and function of specific pelvic floor muscles, causing hypertrophy of peri-urethral striated muscles, thereby increasing the external mechanical pressure on the urethra. Another promising physiotherapy for post-radical prostatectomy incontinence (PPI) is electrical pudendal nerve stimulation (EPNS). An increasing body of research focuses on comparing continence restoration outcomes between PFMT and various electrical stimulations. However, such studies encompass cases with multiple pathological characteristics, and the reported data might not be considered representative or applicable to other populations due to overlooked confounding factors or selection bias. Thus, the investigators intend to conduct a propensity score matching (PSM) study aiming to compare the posttreatment outcomes of patients undergoing either EPNS or PFMT combined with TES, while ensuring a well-balanced control for confounding factor.

Eligibility criteria: Inclusion Criteria:

* Onset of urinary incontinence at least 1 month post-RP
* Minimum two documented incontinence episodes per week in a 7-day bladder diary
* Pathological confirmation of no residual cancer post-RP

Exclusion Criteria:

* High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
* Preoperative incontinence
* Prior anticholinergic treatment
* Urinary tract infection or hematuria
* Postvoid residual volume exceeding 100 ml (determined by bladder ultrasound)
* Neurological disorders
* Urethral stricture

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire-short form score (ICIQ-SF)
timeFrame: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).
Secondary outcomes:
measure: Pad-counting Score
timeFrame: T0 (baseline); T1 (day after 24th treatment); T2 (day after 36th treatment); T3 (day after 48th treatment); T4 (day after 60th treatment); T5 (day after 72nd treatment).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai research institute of acupuncture and meridian
Study officials:
affiliation: Shanghai research institute of acupuncture and meridian
name: Siyou Wang
role: PRINCIPAL_INVESTIGATOR
References: