A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI

CompletedOBSERVATIONAL
Enrollment

389

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

December 31, 2024

Conditions
Urinary Incontinence Following Surgical Procedure
Interventions
PROCEDURE

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.

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.

Trial Locations (1)

200030

Shanghai research institute of acupuncture and meridian, Shanghai

All Listed Sponsors
collaborator

Shanghai Pudong Hospital of Traditional Chinese Medicine

UNKNOWN

lead

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

NCT06130306 - A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI | Biotech Hunter | Biotech Hunter