Pelvic Floor Yoga for Pelvic Pain

(POPPY Trial)

Overseen By Alison Huang, MD, MAS, MPhil

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Analgesics, Antidepressants, Anticonvulsants

Disqualifiers: Pregnancy, Pelvic infection, Surgery, others

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

Compensation: Varies

Number of Visits: 24

220 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Who Is on the Research Team?

Alison Huang, MD

Principal Investigator

University of California, San Francisco

Carolyn Gibson, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pelvic floor yoga program Experimental Treatment 1 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 Control 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. Dumoulin, C., Hay-Smith, J.[2018]

Citations

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

The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. [2019]

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

Development and Feasibility of a Group-Based Therapeutic Yoga Program for Women with Chronic Pelvic Pain. [2022]

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

Pelvic floor muscle exercise for chronic low back pain. [2022]

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

Role of chronic exercise on pelvic floor support and function. [2018]

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

Pelvic floor fitness using lay instructors. [2018]

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

Efficacy of Community-based Pelvic Floor Muscle Training to Improve Pelvic Floor Dysfunction in Chinese Perimenopausal Women: A Randomized Controlled Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The relative activation of pelvic floor muscles during selected yoga poses. [2023]

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

Safety and effectiveness of an internal pelvic myofascial trigger point wand for urologic chronic pelvic pain syndrome. [2022]

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

Exploring the association between lifetime physical activity and pelvic floor disorders: study and design challenges. [2021]

10. China pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

The Effects of Yoga Exercise on Pelvic Floor Rehabilitation of Postpartum Women. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. [2022]

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

Factors Associated With Nonadherence to Pelvic Floor Physical Therapy Referral for the Treatment of Pelvic Pain in Women. [2020]

14. Italy pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment for urinary incontinence in women. A Cochrane systematic review. [2018]

15. Germany pubmed.ncbi.nlm.nih.gov

Physical therapy management of pelvi/perineal and perianal pain syndromes. [2019]