Int J Colorectal Dis. 2026 Mar 5;41(1):76. doi: 10.1007/s00384-026-05110-0.
ABSTRACT
PURPOSE: Magnetoelectric biofeedback therapy (MEBFT) is an emerging intervention for moderate rectocele-associated obstructed defecation syndrome (ODS); however, its efficacy and mechanisms remain unclear. This study compared MEBFT with conventional biofeedback therapy (BFT) and developed a 3D high-resolution anorectal manometry (HR-ARM)-based predictive model for clinical decision-making.
METHODS: In this prospective, single-blind, randomized controlled trial, 68 female patients with defecography-confirmed moderate rectocele-associated ODS were treated in the outpatient department of Tianjin Union Medical Center from January 2019 to June 2024). Patients were randomly assigned in a 1:1 ratio to either the MEBFT or BFT group. Primary outcomes included 3D HR-ARM parameters, Glazer surface electromyography, and patient-reported outcomes (Cleveland Clinic Constipation and Patient Assessment of Constipation Quality of Life scores) at baseline and 3 months. The secondary outcomes included predictive indicators derived from the Hosmer-Rothman model and treatment response stratification.
RESULTS: MEBFT significantly improved fast-twitch fiber recruitment, anorectal function, and quality of life compared to BFT (all P < 0.01). The Hosmer-Rothman model identified a negative MRP-MTV interaction (synergy index = 0.20), with the R11 phenotype (MRP < 80 mmHg-MTV < 135 cc) predicting an 82.35% response to MEBFT after 3 months of treatment (area under the curve [AUC] = 0.72). Phenotypic stratification-guided management: R11 for MEBFT, R00 (elevated MRP-MTV) for surgical evaluation, and R10/R01 for extended MEBFT with surgical backup.
CONCLUSIONS: MEBFT demonstrated superior clinical effectiveness, anorectal functional recovery, and quality of life compared with BFT after 3 months of treatment. The exploratory Hosmer-Rothman model may provided a moderate-accuracy phenotype-based approach using 3D HR-ARM parameters to stratify treatment response and optimize the individualized management of moderate rectocele-associated ODS.
TRIAL REGISTRATION: 1. Date of registration (needs to be before the Date of the First Patient): December 26, 2023. 2. Date of initial participant enrollment: January 9, 2019. 3. Clinical trial identification number: ChiCTR2300079173. 4. URL of the registration site: http://www.chictr.org.cn/.
PMID:41784838 | DOI:10.1007/s00384-026-05110-0
