A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

NCT ID: NCT06130306

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 389 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-31

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.

Conditions

Urinary Incontinence Following Surgical Procedure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Electrical Pudendal Nerve Stimulation Group

Electrical Pudendal Nerve Stimulation

electrical pudendal nerve stimulation

Intervention Type: PROCEDURE

The patient was positioned prone post-micturition. Long needles (0.40 Х 100 mm) were inserted perpendicularly, 1 cm bilateral to the sacrococcygeal joint, to a depth of 80-90 mm, eliciting sensations referred to the urethra or anus. The lower points, 1 cm bilateral to the coccyx tip, received oblique insertion of longer needles (0.40 Х 125 mm) toward the ischiorectal fossa (90-110 mm depth), inducing sensations precisely to the urethra. Connected to a G6805-2 Multi-Purpose Health Device, the ipsilateral needles created an electric loop, with the upper as anode and lower as cathode. Direct electrical stimulation (2.5 Hz, 25\~35 mA) for 45 minutes targeted the pudendal nerve, thrice weekly for a minimum of 8 weeks. The treatment plan remains ongoing until the patient opts to discontinue voluntarily.

Pelvic Floor Muscle Training Group

Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation

pelvic floor muscle training combined with transanal electrical stimulation

Intervention Type: PROCEDURE

Electromyogram BF-assisted PFMT (using a nerve function reconstruction treatment system \[AM1000B; Shenzhen Creative Industry Co. Ltd, China\]) and following TES (using a neuromuscular stimulation therapy system (PHENIX USB 4, Electronic Concept Lignon Innovation, France)) at a current intensity of \< 60 mA (as high as possible to get a PFM contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-minute periods of stimulation) were performed by a specially trained therapist, 20 minutes each time, respectively (a total of 40 minutes), 3 times a week for a total of 8 weeks. The patients also conducted 30 maximal high-intensity PFM contractions for 2-6 seconds (with 2-6 seconds rest), 3 sessions every day at home for a total of 8 weeks. If the patient is willing, the treatment plan can continue until the patient voluntarily decides to stop.

Interventions

electrical pudendal nerve stimulation

The patient was positioned prone post-micturition. Long needles (0.40 Х 100 mm) were inserted perpendicularly, 1 cm bilateral to the sacrococcygeal joint, to a depth of 80-90 mm, eliciting sensations referred to the urethra or anus. The lower points, 1 cm bilateral to the coccyx tip, received oblique insertion of longer needles (0.40 Х 125 mm) toward the ischiorectal fossa (90-110 mm depth), inducing sensations precisely to the urethra. Connected to a G6805-2 Multi-Purpose Health Device, the ipsilateral needles created an electric loop, with the upper as anode and lower as cathode. Direct electrical stimulation (2.5 Hz, 25\~35 mA) for 45 minutes targeted the pudendal nerve, thrice weekly for a minimum of 8 weeks. The treatment plan remains ongoing until the patient opts to discontinue voluntarily.

Intervention Type: PROCEDURE

pelvic floor muscle training combined with transanal electrical stimulation

Electromyogram BF-assisted PFMT (using a nerve function reconstruction treatment system \[AM1000B; Shenzhen Creative Industry Co. Ltd, China\]) and following TES (using a neuromuscular stimulation therapy system (PHENIX USB 4, Electronic Concept Lignon Innovation, France)) at a current intensity of \< 60 mA (as high as possible to get a PFM contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-minute periods of stimulation) were performed by a specially trained therapist, 20 minutes each time, respectively (a total of 40 minutes), 3 times a week for a total of 8 weeks. The patients also conducted 30 maximal high-intensity PFM contractions for 2-6 seconds (with 2-6 seconds rest), 3 sessions every day at home for a total of 8 weeks. If the patient is willing, the treatment plan can continue until the patient voluntarily decides to stop.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siyou Wang

Role: PRINCIPAL_INVESTIGATOR

Shanghai research institute of acupuncture and meridian

Locations

Shanghai research institute of acupuncture and meridian

Shanghai, , China

Countries

China

Other Identifiers

PWRq2022-47

Identifier Type: -

Identifier Source: org_study_id