Pelvic Floor Muscle Training for Spinal Cord Injury

Overseen By Alison Williams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Seizure threshold lowering

Disqualifiers: Pregnancy, Urogenital surgery, Severe medical issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this trial is to learn about the feasibility and benefits of delivering a pelvic floor muscle training program to people with motor-incomplete spinal cord injury. The main questions it aims to answer are: 1. To evaluate the feasibility of delivering a pelvic floor muscle training program to people with spinal cord injury. The investigators will examine recruitment rate, compliance and adherence to the intervention and other study protocols, adverse events, and participant perspectives of the study protocols. 2. To explore the potential effectiveness of pelvic floor muscle training on pelvic floor, bladder, bowel, and sexual function. Participants will be asked to complete a pelvic floor muscle training program for 3 months. At the beginning, middle, and end of the program, researchers will conduct a series of tests to determine the feasibility and potential effectiveness of this program.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications that lower the seizure threshold, you may not be eligible to participate.

What data supports the effectiveness of the treatment Pelvic Floor Muscle Training for Spinal Cord Injury?

There is emerging evidence that pelvic floor muscle training (PFMT) may help treat some urogenital conditions in people with spinal cord injury, and a study found that PFMT, alone or with electrical stimulation, can improve urinary incontinence in women with incomplete spinal cord injury. ^{1 2 3 4 5}

Is pelvic floor muscle training safe for people with spinal cord injury?

Pelvic floor muscle training (PFMT) has been studied for its effects on urinary incontinence in women with spinal cord injury, and no specific safety concerns were reported in the studies reviewed. However, the overall quality of evidence is low due to small sample sizes and non-randomized designs, so while no major safety issues have been identified, more research is needed to confirm its safety. ^{1 2 4 6 7}

How is pelvic floor muscle training different from other treatments for spinal cord injury?

Pelvic floor muscle training (PFMT) is unique because it focuses on strengthening the muscles that support the bladder and bowel, which can help improve urinary incontinence in people with spinal cord injury. Unlike other treatments, PFMT is a non-invasive exercise-based approach that can be done without medication or surgery. ^{1 2 3 4 8}

Research Team

Tania Lam, PhD, PT

Principal Investigator

University of British Columbia, ICORD

Eligibility Criteria

This trial is for adults over 19 with non-progressive, motor-incomplete spinal cord injuries above T12 level, who've had it for at least a year. They should have bladder, bowel, or sexual dysfunction due to the injury and stable management of related health issues.

Inclusion Criteria

I am 19 years old or older.

Are able to speak and understand English

I have a spinal cord injury above T12 that hasn't worsened in over a year.

Exclusion Criteria

Are currently pregnant, have been pregnant within the past 6 months, or are planning to become pregnant in the next 6 months

Have presence of severe medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to pressure sores, cardiovascular disease, and unmanaged diabetes

Have any permanent metal fixtures in their head (excluding dental fillings), or pacemakers, stimulators, or implanted medication pumps

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a pelvic floor muscle training program

12 weeks

3 visits (in-person) at the beginning, middle, and end of the program

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Pelvic Floor Muscle Training

Trial Overview The study tests pelvic floor muscle training's feasibility and effectiveness on improving pelvic floor, bladder, bowel, and sexual function in people with certain spinal cord injuries. Participants will undergo this training program for three months.

Participant Groups

Group I: Pelvic Floor Muscle Training Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

A survey of 153 individuals with spinal cord injury revealed that 63% were aware of pelvic floor muscle training (PFMT), with higher awareness among females compared to males.

Despite positive attitudes towards PFMT, only 20% of respondents had actually practiced it, indicating a gap between awareness and implementation, particularly among those with complete paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, Attitudes, and Practice of Pelvic Floor Muscle Training in People With Spinal Cord Injury: A Cross-Sectional Survey. Sato-Klemm, M., Williams, AMM., Mortenson, WB., et al.[2022]

In a study involving 36 women with incomplete spinal cord injury, pelvic floor muscle training (PFMT) alone significantly improved urinary incontinence symptoms after 12 weeks, while the combination of PFMT with intravaginal electrical stimulation (IVES) did not show additional benefits.

The results indicated that while PFMT alone led to meaningful reductions in urinary incontinence scores, the addition of IVES did not enhance the effectiveness of PFMT, suggesting that PFMT may be sufficient as a standalone treatment for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial. Elmelund, M., Biering-Sørensen, F., Due, U., et al.[2019]

In a study involving 70 female rats, pelvic floor muscle compliance decreased after suprasacral spinal cord injury but began to improve after 8 weeks, indicating a potential recovery trajectory for pelvic floor dysfunction (PFD).

The sacral cord injury group showed similar muscle compliance to healthy rats but exhibited lower contraction activity, suggesting that while some muscle properties may remain intact, overall function is impaired compared to normal levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in pubococcygeus muscle tension in the pelvic floor of rats after spinal cord injury. Lu, Z., Li, JJ., Liao, LM., et al.[2011]

Locomotor training (LT) significantly improved bladder function in eight participants with chronic spinal cord injury, showing increased bladder capacity and efficiency, as well as reduced urinary incontinence after 80 sessions of training.

Participants also reported improvements in bowel and sexual functions, including decreased time for defecation and increased sexual desire, indicating that LT may positively influence non-locomotor functions through enhanced sensory input to the spinal cord.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. Hubscher, CH., Herrity, AN., Williams, CS., et al.[2022]

In a study involving 22 participants with spinal cord injuries, standing training did not significantly improve bladder or bowel functions compared to nonweight-bearing exercises, suggesting that weight-bearing alone is not sufficient for these functional gains.

The results indicate that while general exercise may help lower bladder pressure, task-specific locomotor training is necessary to maximize recovery of pelvic organ functions, highlighting the importance of sensory input to spinal cord circuits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. Hubscher, CH., Wyles, J., Gallahar, A., et al.[2022]

Exercise-based therapies may provide some benefits for urogenital function and quality of life in individuals with spinal cord injury, with moderate improvements in bladder capacity and compliance, but overall evidence quality is low due to small sample sizes and non-randomized designs across the ten studies reviewed involving 228 participants.

Dropout rates for these exercise interventions ranged from 12% to 25%, and while adverse events were reported in some studies, the findings suggest that exercise could improve lower urinary tract symptoms and quality of life, although the evidence is not strong enough to draw definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise-Based Interventions on Urogenital Outcomes in Persons with Spinal Cord Injury: A Systematic Review and Meta-Analysis. Zhou, X., Williams, AMM., Lam, T.[2022]

Individuals with spinal cord injury (SCI) experience significant metabolic changes, including insulin resistance and dyslipidemia, leading to a higher prevalence of coronary artery calcification compared to able-bodied individuals.

Research is ongoing to evaluate the safety and efficacy of anti-hypotensive agents to manage persistent hypotension in individuals with higher-level spinal lesions, which can contribute to cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

31st g. Heiner sell lectureship: secondary medical consequences of spinal cord injury. Bauman, WA., Korsten, MA., Radulovic, M., et al.[2022]

In a study involving 30 female rats, both suprasacral and sacral spinal cord injuries led to significantly decreased excitability and neuropeptide levels in pelvic floor muscles compared to normal rats, indicating a clear impact of spinal cord injury on pelvic floor function.

Rats with spinal cord injury at or below the sacral level exhibited the lowest muscle excitability and neuropeptide levels, suggesting that injuries below the sacral level have a more severe effect on pelvic floor dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison study of pelvic floor muscle tension and neuropeptide level in different level of spinal cord injury]. Lü, Z., Li, JJ., Liao, LM., et al.[2009]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Knowledge, Attitudes, and Practice of Pelvic Floor Muscle Training in People With Spinal Cord Injury: A Cross-Sectional Survey. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Changes in pubococcygeus muscle tension in the pelvic floor of rats after spinal cord injury. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of Exercise-Based Interventions on Urogenital Outcomes in Persons with Spinal Cord Injury: A Systematic Review and Meta-Analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

31st g. Heiner sell lectureship: secondary medical consequences of spinal cord injury. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Comparison study of pelvic floor muscle tension and neuropeptide level in different level of spinal cord injury]. [2009]