220 Participants Needed

Pelvic Floor Yoga for Pelvic Pain

(POPPY Trial)

CG
AH
Overseen ByAlison Huang, MD, MAS, MPhil
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications if you have been on a stable dose for at least 4 weeks. However, you should not start, increase, or decrease any medications that might affect pelvic pain during the study.

What data supports the effectiveness of the treatment Pelvic floor yoga for pelvic pain?

Research shows that therapeutic yoga programs can help reduce pain severity and improve well-being in women with chronic pelvic pain. Additionally, stabilization exercises and pelvic floor muscle exercises have been found to improve pelvic floor function and reduce pain in related conditions.12345

Is pelvic floor yoga safe for humans?

Pelvic floor yoga, when combined with other exercises like Kegel exercises, has been shown to be safe and beneficial for improving pelvic floor dysfunction in women, especially when practiced under the guidance of qualified health professionals.678910

How is pelvic floor yoga different from other treatments for pelvic pain?

Pelvic floor yoga is unique because it combines yoga exercises with pelvic floor rehabilitation, which can improve muscle tension and elasticity, and enhance recovery from pelvic floor disorders. Unlike traditional physical therapy, it incorporates posture and relaxation techniques that may also benefit mental health.1112131415

What is the purpose of this trial?

A randomized, parallel-group, investigator-blinded, comparative effectiveness trial of a fully remote, videoconference-based pelvic floor yoga program versus a physical conditioning program for women with chronic pelvic pain syndrome.

Research Team

AH

Alison Huang, MD

Principal Investigator

University of California, San Francisco

CG

Carolyn Gibson, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for women experiencing chronic pelvic pain, which may be due to conditions like Chronic Pelvic Pain Syndrome or Somatoform Disorder. Specific eligibility criteria are not provided, but typically participants must meet certain health requirements and agree to the study's procedures.

Inclusion Criteria

Report prior clinical evaluation of their pelvic pain by a healthcare professional including at least a superficial pelvic exam
I agree not to start new treatments that could change my pain levels during the study.
I have had pelvic pain for at least 6 months.
See 1 more

Exclusion Criteria

I haven't started, increased, or decreased any medication for pelvic pain in the last 4 weeks.
Inability to understand the informed consent form or fill out questionnaires or complete study interviews
Any other serious physical or mental issue that, in the opinion of the investigators, would interfere with study participation
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Instruction

Participants receive either a pelvic floor yoga program or a physical conditioning program via videoconference, with 75-minute group classes twice weekly

8 weeks
16 virtual visits

Intervention Maintenance

Optional once-weekly, 75-minute drop-in group classes offered to maintain intervention effects

8 weeks
8 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

Treatment Details

Interventions

  • Pelvic floor yoga
  • Physical conditioning
Trial Overview The POPPY study is testing two different remote treatments: a videoconference-based pelvic floor yoga program and a physical conditioning program. Women will be randomly assigned to one of these groups in an effort to determine which method is more effective at managing chronic pelvic pain.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pelvic floor yoga programExperimental Treatment1 Intervention
Instruction in the therapeutic yoga intervention will be delivered through 75-minute group classes occurring twice weekly for a 2-month (8-week) intervention instruction period, involving a trained instructor and an expected 6-10 students (a.k.a. participants) using a secure Zoom videoconference platform. Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period.
Group II: Physical conditioning program (Skeletal muscle stretching and strengthening program)Active Control1 Intervention
The physical conditioning program (skeletal muscle stretching and strengthening program) intervention will begin with a group orientation led by a physical trainer, who will provide an overview of the program. This will be followed by 75-minute twice-weekly group classes, each with an expected class size of 6-10 participants, led by the same physical trainer who has received study-specific training from the study's expert physical therapist consultant, and using a secure Zoom videoconference platform. Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Office of Research on Women's Health (ORWH)

Collaborator

Trials
34
Recruited
36,300+

Findings from Research

Pelvic floor biofeedback therapy is a safe and effective treatment for conditions like chronic constipation, urinary incontinence, fecal incontinence, and pelvic floor pain, particularly for patients without severe pelvic organ prolapse or neurogenic defects.
The therapy's success is enhanced when patients have good mental cognition and adhere to treatment, with training focusing on muscle targeting, coordination, and strength, and its effectiveness evaluated through various symptoms and patient satisfaction.
[Pelvic floor biofeedback therapy in pelvic floor diseases].Ding, S.[2018]
In a review of 21 trials involving 1490 women, pelvic floor muscle training with regular supervision (weekly or bi-weekly group sessions) significantly improved outcomes for women with stress urinary incontinence, with only 10% reporting no improvement compared to 43% in the individual supervision group.
Despite the positive findings, the evidence is not strong enough to recommend a specific training approach, highlighting the need for more consistent and well-defined training protocols in future studies.
Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women.Hay-Smith, EJ., Herderschee, R., Dumoulin, C., et al.[2022]
Pelvic floor muscle training is an effective first-line treatment for women with stress, urge, or mixed urinary incontinence, based on a review of 13 trials involving 714 women.
The review supports the inclusion of pelvic floor muscle training in conservative management programs, although formal meta-analysis was not performed due to study heterogeneity.
Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review.Dumoulin, C., Hay-Smith, J.[2018]

References

The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. [2019]
Development and Feasibility of a Group-Based Therapeutic Yoga Program for Women with Chronic Pelvic Pain. [2022]
Pelvic floor muscle exercise for chronic low back pain. [2022]
Role of chronic exercise on pelvic floor support and function. [2018]
Pelvic floor fitness using lay instructors. [2018]
Efficacy of Community-based Pelvic Floor Muscle Training to Improve Pelvic Floor Dysfunction in Chinese Perimenopausal Women: A Randomized Controlled Trial. [2021]
The relative activation of pelvic floor muscles during selected yoga poses. [2023]
Safety and effectiveness of an internal pelvic myofascial trigger point wand for urologic chronic pelvic pain syndrome. [2022]
Exploring the association between lifetime physical activity and pelvic floor disorders: study and design challenges. [2021]
[Pelvic floor biofeedback therapy in pelvic floor diseases]. [2018]
The Effects of Yoga Exercise on Pelvic Floor Rehabilitation of Postpartum Women. [2023]
Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Factors Associated With Nonadherence to Pelvic Floor Physical Therapy Referral for the Treatment of Pelvic Pain in Women. [2020]
Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. [2018]
Physical therapy management of pelvi/perineal and perianal pain syndromes. [2019]
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