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?

This trial explores the effectiveness of a pelvic floor yoga program compared to a regular physical conditioning program for women with chronic pelvic pain. Participants will attend remote, twice-weekly classes via Zoom over two months. The trial focuses on women who have experienced pelvic pain for more than six months and have already been evaluated by a healthcare professional. The study aims to determine which approach better manages and reduces pain. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance pain management strategies.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that some yoga practices might strain the pelvic floor muscles, potentially worsening pelvic pain in some women. However, another study showed that pelvic pain decreased at varying levels after two months of therapeutic yoga. This suggests that while some yoga movements might not be ideal, a structured pelvic floor yoga program can reduce pain.

Research on physical activity and exercise indicates they can improve overall quality of life and reduce pain intensity. Exercise also benefits mental health and addresses pelvic floor issues.

Both approaches have evidence supporting their safety and effectiveness in managing pelvic pain. Nonetheless, personal comfort and consultation with healthcare providers are important before starting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because pelvic floor yoga and physical conditioning offer unique approaches to managing pelvic pain. Unlike standard treatments, which often include medications or invasive procedures, pelvic floor yoga provides a non-invasive option that combines physical movement with relaxation techniques, potentially benefiting both the body and mind. Meanwhile, the physical conditioning program focuses on stretching and strengthening muscles, which could improve the overall function of the pelvic floor. Both programs are delivered via secure Zoom classes, making them more accessible and convenient for participants who may find it difficult to attend in-person sessions.

What evidence suggests that this trial's treatments could be effective for chronic pelvic pain syndrome?

This trial will compare the effects of pelvic floor yoga and a physical conditioning program on chronic pelvic pain. Studies have shown that pelvic floor yoga can help women with ongoing pelvic pain. Research indicates that participating in this type of yoga program can significantly improve quality of life and reduce pain levels. One study found that women experienced a noticeable decrease in the severity of pelvic pain over a month. Another study showed that pelvic yoga can also reduce daily episodes of urinary incontinence, which often occurs with pelvic pain. Overall, these findings suggest that pelvic floor yoga may effectively manage chronic pelvic pain.

For the physical conditioning program, another treatment arm in this trial, research highlights that general physical therapy, including muscle stretching and strengthening, can also be effective for women with chronic pelvic pain. A review of studies found that this type of physical therapy significantly helps in reducing pain. Thus, both pelvic floor yoga and physical conditioning programs show promise in improving symptoms related to chronic pelvic pain. ^{3 6 7 8 9}

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 have had pelvic pain for at least 6 months.

I agree not to start new treatments that could change my pain levels during the study.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11473233/

Efficacy of a Therapeutic Pelvic Yoga Program Versus ... Over 12 weeks, total UI frequency (primary outcome) decreased by an average of 2.3 episodes/day with pelvic yoga and 1.9 episodes/day with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04615247

NCT04615247 | Program to Overcome Pelvic Pain Study The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function. Participant ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1836955325001092

Supervised exercise and pelvic floor muscle training eases ... The primary outcomes were: change in worst pelvic and genital pain severity over the course of 1 month; and change in conditional pelvic and genital pain, ...

4. ajog.org ajog.org/article/S0002-9378(24)00827-5/fulltext

a systematic review and meta-analysis This systematic review with meta-analysis revealed that multimodal physical therapy is effective in women with chronic pelvic pain with a high ...

5. journals.lww.com journals.lww.com/jwphpt/fulltext/2020/10000/effects_of_yoga_on_quality_of_life_and_pain_in.9.aspx

Effects of Yoga on Quality of Life and Pain in Women With... The published version reads: “Statistically significant improvements were seen following the yoga intervention for within-group analysis of QOL (ES = -1.4, CI: ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6279262/

Development and Feasibility of a Group-Based Therapeutic ... Some yoga practices that have the potential to induce pelvic floor muscle strain may actually precipitate or worsen pelvic pain in women rather than improving ...

7. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/jicm.2024.0682

A Multisite Randomized Feasibility Trial of a Remotely ... From baseline to 2 months, pelvic pain intensity “at its worst,” “at its best,” and “on average” decreased by an average of 1.9, 0.6, and 1.1 points, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05899088

NCT05899088 | Mindful Movement for Pelvic Pain Chronic pelvic pain is often associated with negative cognitive, behavioral, sexual and emotional consequences, which can include physical deconditioning, pain ...

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0317820

The effectiveness and safety of physical activity and exercise ... The results indicated that physical activity and exercise have a beneficial impact on quality of life, pain intensity, mental health, pelvic floor dysfunction, ...