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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a pelvic floor muscle training program can assist individuals with certain types of spinal cord injuries. Researchers seek to assess its practicality and benefits for enhancing pelvic floor, bladder, bowel, and sexual function. Participants will engage in a specialized exercise program for three months, with tests conducted at various intervals to monitor progress. Suitable candidates have experienced a spinal cord injury affecting movement for at least a year and have issues with bladder, bowel, or sexual function due to this injury. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance the quality of life for those with similar conditions.

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 prior data suggests that this pelvic floor muscle training is safe for people with spinal cord injury?

Research has shown that pelvic floor muscle exercises are generally safe for people with spinal cord injuries. Studies have found that most participants handle this exercise treatment well, with few reports of serious side effects. In one study, these exercises helped women with partial spinal cord injuries manage urinary incontinence and were considered safe and beneficial. Another study combined these exercises with catheter use and observed improvements in bladder function without major problems. Overall, pelvic floor muscle exercises appear well-tolerated, with few negative effects reported, making them a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pelvic Floor Muscle Training for spinal cord injury because it offers a non-invasive approach to improving bladder control, which is often a major issue for patients with this condition. Unlike medications that can have side effects or require long-term use, this training method focuses on strengthening the pelvic floor muscles to enhance their function naturally. It empowers patients to take an active role in their rehabilitation, potentially leading to improved quality of life without the drawbacks of more traditional treatments like surgery or medication.

What evidence suggests that pelvic floor muscle training might be an effective treatment for spinal cord injury?

Research shows that pelvic floor muscle exercises can benefit people with spinal cord injuries. Studies have found that performing these exercises regularly for just six weeks can strengthen and sustain these muscles in individuals with incomplete spinal cord injuries. This training might also aid bladder control, a common challenge for those with spinal cord injuries. Some research suggests that combining these exercises with other treatments, such as occasional catheter use, can enhance bladder function. Overall, pelvic floor exercises appear promising for improving pelvic floor, bladder, and possibly sexual health in this group. ^{1 4 5 6 7}

Who Is on the Research Team?

Tania Lam, PhD, PT

Principal Investigator

University of British Columbia, ICORD

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397781/

Knowledge, Attitudes, and Practice of Pelvic Floor Muscle ... There is emerging evidence that pelvic floor muscle training (PFMT) may be useful for treating some urogenital conditions in people with spinal ...

2. nature.com nature.com/articles/sc2015121

Pelvic floor muscle training in spinal cord injury and its ... 6 weeks of regular pelvic floor muscle training (PFMT) can improve the strength and endurance of voluntary contractions in incomplete spinal cord injury.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9997793/

Effects of acupuncture and pelvic floor muscle training on ... Influence of intermittent catheterization combined with pelvic floor muscle training on neurogenic bladder in patients with spinal cord injury.

4. ics.org ics.org/2019/abstract/545

Exploring pelvic floor muscle sparing in individuals with ... The activation score ranged from 64-100% (mean 90%) for AB participants with the gluteal contraction and Kegel producing the most consistent ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06515223

Improving Pelvic Rehabilitation Using Epidural Stimulation ... Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1089/neu.2020.7454

Effects of Exercise-Based Interventions on Urogenital ... The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/10/8/e034582

a study protocol for a randomised controlled trial This study aims to provide a detailed rationale and methodology for comparing the effectiveness of PFMT, biofeedback and repetitive transcranial magnetic ...