An interventional study of Kegel Exercise with Biofeedback and Kegel Exercise Only in Rectal Cancer, Low Anterior Resection Syndrome and LARS - Low Anterior Resection Syndrome, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
This randomized controlled trial aims to evaluate the effects of combining Kegel exercise with a single biofeedback session on bowel function, emotional distress, and quality of life in patients who have undergone low anterior resection (LAR) for rectal cancer. Low anterior resection syndrome (LARS) is a common postoperative complication following LAR, characterized by increased stool frequency, urgency, and incontinence, which can significantly impair patients' psychological well-being and daily quality of life. Participants will be randomly assigned to one of two groups: (1) Kegel exercise combined with one non-invasive biofeedback session, or (2) Kegel exercise alone. Both groups will perform home-based Kegel exercises for eight weeks. The study aims to determine whether the combined biofeedback and Kegel exercise intervention results in greater improvements in bowel control, emotional well-being, and quality of life compared with Kegel exercise alone.
Background:
Patients who undergo low anterior resection (LAR) for rectal cancer often experience low anterior resection syndrome (LARS), characterized by frequent bowel movements, urgency, and incontinence. These symptoms can cause considerable psychological distress and impair daily functioning. Pelvic floor muscle training (PFMT, commonly known as Kegel exercise) is a widely used bowel rehabilitation method; however, its effectiveness depends on patients' ability to perform the exercises correctly. Biofeedback therapy (BFT) provides real-time visual and auditory feedback to help patients better control pelvic floor muscle contractions and relaxations, thereby improving training precision.
Objective:
To examine whether combining a single biofeedback intervention with Kegel exercise produces greater improvements in bowel function, emotional distress, and quality of life than Kegel exercise alone in patients after low anterior resection for rectal cancer.
Methods:
This is a prospective randomized controlled trial (IRB No. 202502004RINB) to be conducted at National Taiwan University Hospital. A total of 66 eligible participants who have completed at least four weeks after LAR will be recruited. Participants will be randomized (1:1) into experimental and control groups using block randomization with block sizes of 4, 6, or 8.
The experimental group will receive one 30-minute session of non-invasive electromyographic biofeedback training to correct pelvic floor muscle contraction and relaxation techniques, followed by Kegel exercise instruction. The control group will receive only verbal instruction and demonstration of Kegel exercises without the use of biofeedback devices.
Both groups will continue home-based Kegel exercises for eight weeks, with a total follow-up period of twelve weeks. Assessments will be conducted at four time points: baseline (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3).
Outcome Measures:
Primary outcome: Low Anterior Resection Syndrome Score (LARS Score). Secondary outcomes: Hospital Anxiety and Depression Scale (HADS), The World Health Organization Quality of Life Assessment-BREF Taiwan version (WHOQOL-BREF Taiwan version).
Expected Results:
The experimental group (Kegel exercise combined with single-session biofeedback) is expected to demonstrate greater improvements in bowel function, reduced emotional distress, and enhanced quality of life compared with the Kegel-only group.
Significance:
This study aims to establish a low-cost, non-invasive, and feasible postoperative rehabilitation approach to enhance bowel recovery and improve the quality of life in patients after rectal cancer surgery.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 66 is close to the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Kegel Exercise with Biofeedback
Behavioral: Kegel Exercise Only
A single 30-minute non-invasive EMG biofeedback session will guide participants to correctly contract and relax pelvic floor muscles using real-time visual and auditory feedback. Conducted by trained healthcare staff in the physical therapy center, with additional outpatient or ward instruction if needed. After the session, participants perform home-based Kegel exercises for 8 weeks (3-5 times/day, 6-8 contractions/set, hold 5-10 sec, relax 10 sec, ≥5 days/week). Research staff will follow up every 1-2 weeks by phone to monitor adherence and adjust intensity. If stable 5-sec contractions are achieved, duration or frequency may increase; if fatigue, abdominal pressure, or discomfort occurs, training will be reduced or paused for safety.
Also known as: Kegel Exercise with Biofeedback (Kegel + BFT)
Participants in the control group will receive a single 30-minute session of verbal instruction and demonstration on Kegel exercise by trained medical personnel, without the use of any biofeedback device. The provider, setting, duration, exercise dosage, and follow-up schedule are identical to those in the experimental group.
Also known as: Kegel Exercise
Change in Bowel Function Measured by the Low Anterior Resection Syndrome (LARS) Score
Bowel function will be assessed using the validated Low Anterior Resection Syndrome (LARS) score, which consists of five items evaluating incontinence, frequency, clustering, and urgency. The total score ranges from 0 to 42, with higher scores indicating more severe bowel dysfunction.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
Change in Emotional Distress Measured by the Hospital Anxiety and Depression Scale (HADS)
Emotional distress will be measured using the Hospital Anxiety and Depression Scale (HADS), which includes 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D). Each subscale has a score range of 0-21, with higher scores indicating greater emotional distress.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
The World Health Organization Quality of Life Assessment-BREF (WHOQOL-BREF)
Quality of life will be assessed using the WHOQOL-BREF Taiwan version, a 28-item instrument developed by the WHOQOL Group and culturally adapted for use in Taiwan. The scale measures four major domains-Physical Health, Psychological Health, Social Relationships, and Environment-as well as two national items relevant to local culture. Scores in each domain are transformed to a 4-20 scale, with higher scores indicating better perceived quality of life.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 23 months is below that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Dec 2026 → Dec 2027 and completion Jan 2027 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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