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 <OrderedList> <ListItem> <ItemNumber>1.</ItemNumber> <ItemContent> Date of registration (needs to be before the Date of the First Patient): December 26, 2023. </ItemContent> </ListItem> <ListItem> <ItemNumber>2.</ItemNumber> <ItemContent> Date of initial participant enrollment: January 9, 2019. </ItemContent> </ListItem> <ListItem> <ItemNumber>3.</ItemNumber> <ItemContent> Clinical trial identification number: ChiCTR2300079173. </ItemContent> </ListItem> <ListItem> <ItemNumber>4.</ItemNumber> <ItemContent> URL of the registration site: <a href="http://www.chictr.org.cn/">http://www.chictr.org.cn/</a> </ItemContent> </ListItem> </OrderedList>

Magnetoelectric biofeedback for precision-targeted rectocele management: A randomized controlled trial of phenotype-driven pelvic floor neuromodulation

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2026年3月5日

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Hong Zhi Geng,
Chen Xu,
Jiying Cong,
Yuwei Li

摘要

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

Date of registration (needs to be before the Date of the First Patient): December 26, 2023.

Date of initial participant enrollment: January 9, 2019.

Clinical trial identification number: ChiCTR2300079173.

URL of the registration site: http://www.chictr.org.cn/